Search trials – HealthDB

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Намерени 282 изпитвания Стр. 10 от 15

Active (not recruiting) Phase 3

A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

Chronic inflammatory demyelinating polyneuropathy (CIDP)

Trial status: Authorised 1. Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) centile points score at week 24, 2. Change from baseline in Medical Research Council Sum Score (MRC-SS) at week 24, 3. Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24, 4. Time to reduction of ≥1 point from baseline in aINCAT score, 5. Change from baseline in Timed Up and Go (TUG) at week 24, 6. Time to increase of ≥1 point compared with baseline in aINCAT score by week 24, 7. Change from baseline in grip strength (3-day moving average) of both hands over time and change from baseline in grip strength (daily average) for both hands, 8. Change from baseline in aINCAT over time, 9. Change from baseline in I-RODS centile points score over time, 10. Change from baseline in MRC-SS over time, 11. Change from baseline in TUG over time, 12. Change from baseline in EQ-5D-5L, RT-FSS, SF-12 and BPI-SF over time, 13. PGI-S and PGI-C values over time, 14. Values for work-related and household chore activities of the HRPQ, 15. Percentage of scheduled hours lost in total (absenteeism + presenteeism), 16. Incidence and prevalence of antidrug antibodies and neutralizing antibodies against empasiprubart in serum, 17. Incidence and severity of adverse events, incidence of serious adverse events and clinically meaningful changes in laboratory parameters, ECG results, and vital signs, 18. Absolute values and percentage change from baseline in free C2 and total C2 over time, 19. Serum concentrations of empasiprubart over time Decrease of ≥1 point compared with baseline in aINCAT score at week 24

Начало: 01.12.2025 Възраст: от 18 г.

Austria, Bulgaria, Czech Republic +16 Argenx 2024-520097-36-00

Active (not recruiting) Phase 2

A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-407 in Subjects with Autosomal Dominant Polycystic Kidney Disease Who Have a Subset of PKD1 Gene Variants

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Trial status: Authorised Percent change from baseline in htTKV on MRI over time, Safety and tolerability of VX¬407 based on adverse events (AEs), clinical laboratory values (i.e., hematology, serum chemistry, coagulation), standard 12-lead ECGs, and vital signs, Plasma PK parameters of VX 407 Proportion of subjects with percent change from baseline in htTKV ≤0 on MRI over time

Начало: 28.11.2025 Възраст: 18–64 г.

Belgium, France, Germany +3 Vertex Pharmaceuticals Inc. 2024-517393-13-00

Active (not recruiting) Phase 3

A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants with Acute Suicidal Ideation or Behavior

Major Depressive Disorder

Trial status: Authorised Change from baseline (Day 1, predose) at 24 hours post first dose in depressive symptoms, as measured by the CDRS-R total score

Начало: 19.11.2025

Hungary, Italy, Romania +1 Janssen Cilag International 2024-518615-19-00

Active (not recruiting) Phase 2

Phase 1/2 Study of PYX-201 in Combination with Pembrolizumab in Advanced Solid Tumors

Advanced Solid Tumors

Trial status: Authorised

Начало: 19.11.2025 Възраст: от 18 г.

France, Poland, Spain Pyxis Oncology Inc. 2025-521828-30-00

Active (not recruiting) Phase 3

A Phase III, Randomized, Open-Label, Multicenter, Global Study of Puxitatug Samrotecan (AZD8205) Monotherapy versus Physician’s Choice of Chemotherapy in Participants with B7-H4-Selected Advanced/Metastatic Endometrial Cancer Who Progressed On or After Platinum-Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (Bluestar-Endometrial01)

B7-H4-Selected Advanced/Metastatic Endometrial Cancer.

Trial status: Authorised ORR is defined as the proportion of participants who have a response of CR or PR, as determined by BICR assessments, per RECIST 1.1., DoR will be defined as the time from the date of first documented response until the date of documented progression per RECIST 1.1 as assessed by BICR, or death due to any cause., PFS2 will be defined as the time from randomization to the earliest of the progression event (following the initial Investigator-assessed progression), after first subsequent therapy, or death., TFST is defined as the time from randomization until the start date of the first subsequent anticancer therapy after discontinuation of the randomized treatment, or death due to any cause., TSST is defined as the time from randomization until the start date of the second subsequent anticancer therapy after discontinuation of the first subsequent treatment, or death due to any cause., TDT is defined as the time from randomization until discontinuation of treatment for any reason, including disease progression, toxicity, and death., Time to worsening is defined as time from date of randomization to the date of worsening while on treatment for endometrial symptoms, physical functioning, and health-related quality of life based on select items from the EORTC IL389. PFS is defined as the time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause., OS is defined as the time from randomization until the date of death due to any cause.

Начало: 17.11.2025 Възраст: от 18 г.

Austria, Belgium, Czech Republic +12 AstraZeneca AB 2024-518777-34-00

Active (not recruiting) Phase 3

Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL.

Framework for Optimizing Refining and Unifying Management of HSCT in Pediatric ALL

Trial status: Authorised R1 Sub-Study: The primary endpoint is Event Free Survival (EFS) at year 4. EFS is defined as the time from randomization (intention-to-treat analysis) or HSCT (per-protocol/as treated) to first failure event defined as follows: Failure events are: • Relapse • Death from any cause • Diagnosis of a second malignant neoplasm Patients without event will be censored at last follow-up date., R2 Sub-Study: • Overall response rate (ORR) at Day 28 after randomization, defined as the proportion of patients in each arm demonstrating a complete response (CR) or partial response (PR) without requirement for additional systemic therapies for earlier progression, mixed response or nonresponse. Scoring of response will be relative to the organ stage at the time of randomization., S1 Sub-Study: EFS is defined as the time from HSCT to first failure event defined as follows: Failure events are: - Relapse - Graft failure - Death from any cause - Diagnosis of a second malignant neoplasm Patients without event will be censored at last follow-up date., P1 Sub-Study: Compare the CIR 2 years after HSCT in blinatumomab-treated patents and historical controls. CIR is calculated from the time of study enrolment until the date of relapse (defined as either bone marrow aspirate or biopsy with ≥ 5% blasts or as appearance of leukemia cells in an extramedullary site) or last follow-up (death from any cause other than leukemia relapse will be considered a competing event).

Начало: 17.11.2025 Възраст: 18–64 г.

Austria, Czech Republic, Denmark +6 Ospedale Pediatrico Bambino Gesu 2025-522052-13-00

Active (not recruiting) Phase 1

A first study in humans testing the safety and effects of KUP-101A in patients with certain advanced solid cancers

Advanced solid tumors (cutaneous melanoma mucosal melanoma cutaneous squamous cell carcinoma Merkel cell carcinoma +1

Trial status: Authorised

Начало: 12.11.2025 Възраст: от 18 г.

Germany Kupando GmbH 2025-522402-21-00

Active (not recruiting) Phase 3

A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients with BRCAm Localised High-risk Prostate Cancer Receiving Radiotherapy with Androgen Deprivation Therapy (EvoPAR-Prostate02)

Prostate Cancer

Trial status: Authorised OS is defined as the time from randomisation until the date of death due to any cause., MFS is defined as the time from randomisation until the date of distant metastases, confirmed by conventional imaging (CT/MRI and bone scan), or death due to any cause., MFS is defined as the time from randomisation until the date of distant metastases, confirmed by PSMA-PET imaging or death due to any cause., MFS is defined as the time from randomisation until the date of distant metastases, confirmed by standard clinical imaging (CT/MRI and bone scan or PSMA-PET), histology, or death due to any cause., Time from randomisation to PFS2 is defined as the time from randomisation to the earliest of progression [defined as radiographic progression, clinical progression, or prostate-specific antigen (PSA) progression] after initiation of first subsequent systemic treatment following the initial investigator-assessed progression or death. The date of second progression will be investigator assessed according to local standard clinical practice., Time to biochemical recurrence is defined as the time from randomisation to biochemical recurrence per Phoenix criteria., PCSS is defined as the time from randomisation until the date of death due to the underlying prostate cancer., TTDUS is defined as the time from randomisation to deterioration in EORTC-QLQ-PR25 (US) subscale scores., TTDPF is defined as the time from randomisation to deterioration in EORTC-QLQ-C30 Physical Function subscale scores, To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety). MFS is defined as the time from randomisation until the date of first appearance of distant metastases, confirmed by standard clinical imaging [computed tomography (CT)/ magnetic resonance imaging (MRI) and bone scan, or prostate-specific membrane antigen-positron emission tomography (PSMA-PET)], as assessed by blinded independent central review (BICR) or death due to any cause.

Начало: 12.11.2025 Възраст: от 18 г.

Austria, Belgium, Finland +8 AstraZeneca AB 2024-513586-39-00

Active (not recruiting) Phase 2

Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis

Trial status: Authorised Part A: 1. Clinical remission at Week 12., Part A: 2. Endoscopic improvement at Week 12., Part A: 3. Change in modified Mayo score from baseline at Week 12., Part A: 4. Study drug concentration through Week 12., Part A: 5. Percentage of participants with ADAs to study drug(s) through Week 12., Part B: 1. Endoscopic improvement at Week 12., Part B: 2. Clinical response at Week 12., Part B: 3. Histologic improvement at Week 12., Part B: 4. HEMI at Week 12., Part B: 5. Clinical remission at Week 48., Part B: 6. Study drug concentration through Week 12., Part B: 7. Percentage of participants with ADA to study drug(s) through Week 12. Part A: Change in RHI from baseline at Week 12., Part B: Clinical remission at Week 12.

Начало: 10.11.2025 Възраст: от 18 г.

Austria, Belgium, Bulgaria +13 Spyre Therapeutics Inc. 2025-521242-26-00

Active (not recruiting) Phase 3

STOP-PKD: SGLT2-inhibition to improve Prognosis in Polycystic Kidney Disease

Autosomal dominant polycystic kidney disease (ADPKD)

Trial status: Authorised Off-treatment values: eGFR change from before to after treatment (using the mean of two creatine measurements for each timepoint; week -4 and 0 for before treatment; week 162 and 168 for follow-up), Composite outcome: Sustained 40 % decrease in eGFR from randomization (confirmed by second measurement in next scheduled visit or measured at the last study follow-up visit / the last scheduled visit before death) • OR ESKD: start of dialysis or kidney transplantation or sustained eGFR

Начало: 06.11.2025 Възраст: 18–64 г.

Austria, Germany, Netherlands +1 University Of Cologne 2025-521276-59-00

Active (not recruiting) Phase 3

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1020 for the Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD)

Facioscapulohumeral Muscular Dystrophy (FSHD)

Trial status: Authorised 1.1 Key Secondary Endpoints • Change from Baseline to Week 78 in: o Timed-Up-and-Go (TUG) velocity o NeuroQoL Upper Extremity Function o Quantitative Muscle Testing (QMT) total composite score (PPN), 1.2 Other Secondary Endpoints • Change from Baseline over time in: o Patient-reported Outcomes Measurement Information System instruments (PROMIS) (Physical Function) o PROMIS Fatigue o Worst Pain Numerical Rating Scale (NRS) o Patient Global Impression of Severity (PGI-S)/Patient Global Impression of Change (PGI-C) o Quality of Life in Neurological Disorders (NeuroQoL) Sleep Disturbance o DUX4-regulated plasma KHDC1L o Serum CK Change from Baseline to Week 78 in 10MWRT velocity (m/sec)

Начало: 04.11.2025 Възраст: от 18 г.

Denmark, France, Germany +3 Avidity Biosciences Inc. 2025-521012-18-00

Active (not recruiting) Phase 2

A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults with Lewy Body Dementia Psychosis (LBDP)

Lewy Body Dementia Psychosis (LBDP)

Trial status: Authorised Change from Baseline in SAPS-LBDP total score at Week 6

Начало: 29.10.2025 Възраст: от 18 г.

Bulgaria, Czech Republic, France +1 Acadia Pharmaceuticals Inc. 2025-521710-25-00

Active (not recruiting) Phase 4

LIVER AKI: A randomized, open-label trial to evaluate the efficacy of intravenous human albumin administration versus saline solution (NaCl 0.9%) in patients with decompensated cirrhosis and AKI 1B or grater.

descompensated hepatic cirrosis

Trial status: Authorised Survival rate at 28 days, considering liver transplantation as a competitive risk event, AKI improvement, defined as the percentage of patients who decrease at least 1 grade of AKI classification (from 3 to 2, from 2 to 1B, and from 1B to 1A or recovery), without the need for RRT, Proportion of patients requiring RRT In both groups, Changes from baseline in systemic inflammatory response, evaluated by measurement in a large array of plasma cytokine levels including, but not limited to TNFα, IL-6, IL8, IL-10, IL-1β, IFN-ɣ, G-CSF, VCAM, VEGF, as well as an oxidized form of albumin, human nonmercaptalbumin-2 (HNA2) at visits 1, 2, 4, 5 and 6, Changes from baseline in different plasma and urine prognostic biomarkers including, but not only, copeptin, NGAL, PD-L1, L-FABP at visits 1, 2, 4, 5 and 6., Changes from baseline in systemic hemodynamics and vasoactive hormones: plasma renin concentration and plasma copeptin at visits 1, 2, 4, 5 and 6,, Changes in echocardiographic parameters (E/E', ITV, among others) at visit 1, 2, 7 and 28., Proportion of patients and severity of treatment-related adverse events during the study period Analyze the effect of HA versus (NaCl 0.9%) administration on the probability of AKI resolution among patients with decompensated cirrhosis and AKI 1B or greater acute kidney injury (AKI) clinical efficacy of HA versus saline (NaCl 0.9%) administration in patients with AKI 1B or higher will be evaluated, defining AKI resolution as the percentage of patients with a decrease in serum creatinine levels < 0.3 mg/dL with respect to baseline serum creatinine, without the need for TRT.

Начало: 29.10.2025 Възраст: от 18 г.

Spain Fundacio De Recerca Clinic Barcelona-Institut D’Investi 2025-521457-16-00

Active (not recruiting) Phase 2

A Phase 2b, Multi-center, Randomized, Double-blind, Placebo controlled Study of IMVT-1402 Treatment in Adult Participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Trial status: Authorised Change from baseline to Week 24 in I-RODS., Change from baseline to Week 24 in Mean Grip Strength in the dominant hand., Change from baseline to Week 24 in MRC-SS., Change from baseline to Week 24 in aINCAT score. The proportion of participants remaining Relapse-free by Week 24.

Начало: 28.10.2025 Възраст: от 18 г.

Austria, Belgium, Bulgaria +16 Immunovant Sciences GmbH 2024-517614-14-00

Active (not recruiting) Phase 3

A Phase III, randomized, multi-site, open-label trial of BNT323/DB-1303 versus investigator’s choice of chemotherapy in previously treated patients with HER2- expressing recurrent endometrial cancer

Endometrial cancer

Trial status: Authorised Cohort 1, by treatment arm: overall survival (OS) defined as the time from randomization to death from any cause., Cohort 1, by treatment arm: PFS assessed by the investigator defined as the time from randomization to the first objective tumor progression (per RECIST 1.1) or death from any cause, whichever occurs first., Cohort 1, by treatment arm: Objective response rate (ORR) defined as the proportion of participants with a complete response (CR) or partial response (PR) (per RECIST 1.1) as best overall response with confirmation., Cohort 1, by treatment arm: Duration of response (DoR) defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective tumor progression (progressive disease [PD] per RECIST 1.1) or death from any cause, whichever occurs first., Cohort 1, by treatment arm: Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs by relationship from the time of initiation of the first dose of trial treatment to 35 days after the last trial treatment dose., Cohort 1, by treatment arm: Occurrences of TEAEs leading to drug interruption, dose reduction, or discontinuation of trial treatment., For Cohort 2, for BNT323 monotherapy: ORR assessed by the investigator, defined as the proportion of participants with a CR or PR (per RECIST 1.1) as best overall response with confirmation., For Cohort 2, for BNT323 monotherapy: DoR defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective tumor progression (PD per RECIST 1.1) or death from any cause, whichever occurs first., For Cohort 2, for BNT323 monotherapy: PFS defined as the time from the first dose of trial treatment to the first objective tumor progression (per RECIST 1.1) or death from any cause, whichever occurs first., For Cohort 2, for BNT323 monotherapy: OS defined as the time from the first dose of trial treatment to death from any cause., For Cohort 2, for BNT323 monotherapy: Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs by relationship from the time of initiation of the first dose of trial treatment to 35 days after the last trial treatment dose., For Cohort 2, for BNT323 monotherapy: Occurrences of TEAEs leading to drug interruption, dose reduction, or discontinuation of trial treatment. Cohort 1: By treatment arm, PFS by BICR defined as the time from randomization to the first objective tumor progression (per RECIST 1.1) or death from any cause, whichever occurs first., Cohort 2: For BNT323 monotherapy, objective response rate (ORR) assessed by blinded independent central review (BICR), defined as the proportion of participants with a complete response (CR) or partial response (PR) (per RECIST 1.1) as best overall response with confirmation.

Начало: 27.10.2025 Възраст: от 18 г.

Austria, Belgium, Czech Republic +12 BioNTech SE 2023-507525-42-00

Active (not recruiting) Phase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated with Mild to Moderate Alzheimer’s Disease (MINDSET 1)

Mild to moderate Alzheimer’s Disease

Trial status: Authorised Change from baseline in ADCS-ADL at Week 24, Change from baseline in NPI total score at Week 24, Occurence of AEs and SAEs, AESIs, AEs leading to study intervention discontinuation, AEs leading to study discontinuation, and AEs leading to death through Week 24, Incidence and severity of clinically significant changes in vital signs, ECG, C-SSRS, weight, and safety laboratory tests through Week 24 Change from baseline in ADAS-Cog11 at Week 24, CIBIC+ at Week 24

Начало: 21.10.2025 Възраст: от 18 г.

Croatia, Czech Republic, Germany +5 Bristol-Myers Squibb Services Unlimited Company 2025-520746-30-00

Active (not recruiting) Phase 2

A Phase 2, Multicenter, Randomized, Double blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of NGM120 in Participants with Colorectal Cancer who have Cancer Cachexia

Colorectal Cancer with Cancer Cachexia

Trial status: Authorised Key: Change from baseline in body weight at Week 16, Change from baseline over time in: − FAACT sub-scale scores (FAACT-ACS, FAACT-5IASS) − PROMIS (fatigue 7a & physical function 8c) − PGI-S and PGI-C (appetite and fatigue) − PGI-S and PGI-C (physical activity and walking), Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug, Change in body weight over time, Serum concentration and PK parameters of NGM120., Incidence and titer of ADA and NAb over time. Change from baseline in body weight at Week 12, Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug

Начало: 21.10.2025 Възраст: от 18 г.

Bulgaria, Czech Republic, Hungary +2 Ngm Biopharmaceuticals Inc. 2025-521730-28-00

Active (not recruiting) Phase 3

The IMAGINE study: A phase 3b open label, single arm study to assess the effect of depemokimab on airway structure and function in asthma with Type 2 inflammation characterized by an eosinophilic phenotype utilizing quantitative high-resolution CT and bronchoscopic airway sampling in a sub study

Asthma with type 2 inflammation characterized by an eosinophilic phenotype

Trial status: Authorised Change from baseline in airway wall thickness measured at TLC at Week 52. Change from baseline in total mucus plug volume measured at TLC at Week 26

Начало: 20.10.2025 Възраст: от 18 г.

Belgium, France, Germany +3 Glaxosmithkline Research & Development Limited 2024-519976-19-00

Active (not recruiting) Phase 2

EPIK-P4: A Phase II single arm study to assess the efficacy, safety and pharmacokinetics of alpelisib (BYL719) in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS)

PIK3CA-Related Overgrowth Spectrum (PROS)

Trial status: Authorised Changes from baseline in PROS lesion volumes(as assessed by BIRC) in the: • Sum of target lesion volume. • Sum of MRI-measurable non-target lesion volume. • Sum of all MRI-measurable (target and nontarget)lesion volume. Change from baseline in other non-target lesions(by BIRC). Appearance of new lesions (by BIRC)., Proportion of participants with a radiological response at scheduled protocol timepoints, Duration of response defined as the time from the first documented confirmed objective response until progression of any PROS lesion (by BIRC) or death due to any cause or rescue surgery for any PROS lesion, whichever comes first, Alpelisib plasma concentration at selected time points., Change in scores from Brief Pain Inventory (BPI) items, or Wong-Baker Faces Scale (age appropriate), and Patient Global Impression of Symptom Severity (PGI-S)., Time to treatment failure (TTF) is defined as the time from alpelisib treatment start date until disease progression confirmed by BIRC, death, rescue surgery for any PROS lesion or discontinuation of the study treatment due to any reason other than technical problems or study termination by the sponsor., Overall clinical response as assessed by Investigator, Change from baseline in PROS-related symptoms and in complications/comorbidities among participants with symptoms and complications/comorbidities present at baseline., Number/percentage of participants with healthcare visits/hospitalized due to PROS; number of hospitalizations. Number/percentage of participants with surgeries required to manage PROS; number of surgeries., Incidence, type and severity of treatment-emergent adverse events per CTCAE v4.03 criteria and other safety data including changes in laboratory values, vital signs, assessments of cardiac function, growth, bone/dental development and sexual maturation (for applicable age). Proportion of participants achieving confirmed objective response at any time, defined as achieving radiological response confirmed by a subsequent assessment performed at least after 4 weeks.

Начало: 20.10.2025 Възраст: от 18 г.

Austria, Belgium, France +4 Novartis Pharma AG 2024-519960-42-00

Active (not recruiting) Phase 3

A Global, Multicenter, Prospective, Controlled, Open-Label Pivotal Study of Iodofalan (131I) Solution for Injection (TLX101-Tx) Plus Lomustine Versus Lomustine Alone in Patients with Radiographically Confirmed Recurrent Glioblastoma at First Recurrence (IPAX-3)

Glioblastoma

Trial status: Authorised Part 1 Safety and Dosimetry Lead-In: Part 1a and 1b:Absorbed radiation doses based on quantitative imaging (expressed as mGy/MBq of administered TLX101-Tx) to tumor and bone marrow, using SPECT imaging. The planar images of the head and tumor volume estimates from CT/MRI will be used to obtain an estimate of the tumor dose per administered activity of 131I., Part 1a and 1b: Time course of the radioactivity and of TLX101 in blood and cumulative urine excretion of the radioactivity after administration of TLX101-Tx Blood and urine PK parameters of TLX101-Tx, PK/PD modeling will be performed using venous blood samples and if data allows, exposure-response analyses will be performed to correlate blood PK metrics and/or tumor and organ absorbed doses to efficacy and safety endpoints., Part 1a BOIN: Safety assessments include physical examination, vital signs, ECG abnormalities, clinical laboratory assessments, adverse events reported according to the NCI CTCAE v5.0. Tolerability as assessed by HRQoL total scores on European Organization for Research and Treatment of Cancer – EORTC QLQ-C30 and EORTC-BN20 questionnaires, neurological symptoms assessed with the NANO scale., Part 1b Dose Expansion Cohort: PFS from the time of enrollment as assessed by central core lab using RANO 2.0 or death due to any cause (whichever occurs first)., Part 1b Dose Expansion Cohort: Objective response rate assessed by the central core lab according to RANO 2.0., Part 2 Randomized Study: PFS from the date of enrollment randomization per RANO 2.0 criteria as assessed by the central core lab or death due to any cause (whichever occurs first)., Part 2 Randomized Study: Tolerability as assessed by HRQoL total scores on European Organization for Research and Treatment of Cancer – EORTC QLQ-C30 and EORTC-BN20 questionnaires., Part 2 Randomized Study: Safety assessments include physical examination, vital signs, and clinical laboratory assessments as well as adverse events reported according to the NCI CTCAE v5.0. Part 1 Safety and Dosimetry Lead-in: Part 1a BOIN: Assessment of TEAEs type as described as dose-limiting, frequency, severity according to NCI CTCAE v5.0., Part 1 Safety and Dosimetry Lead-in: Part 1b Dose Expansion Cohort: Safety assessments include physical examination, vital signs, ECG abnormalities, clinical laboratory assessments, adverse events reported according to the NCI CTCAE v5.0. Tolerability as assessed by HRQoL total scores on European Organization for Research and Treatment of Cancer – EORTC QLQ-C30 and EORTC-BN20 questionnaires, neurological symptoms assessed with the NANO scale., Part 2 Randomized Study: OS determined from the date of enrollment until death from any cause.

Начало: 13.10.2025 Възраст: от 18 г.

Austria, Belgium, Netherlands Telix Pharmaceuticals (Innovations) Pty Limited 2025-521785-10-00

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