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Recruiting Phase 1 NCT07127874

A Study of PHN-012 in Patients With Advanced Solid Tumors

Phase 1 – testing safety in a small group of people
Conditions: Colon Cancer Pancreatic Cancer Lung Cancer (NSCLC) Advanced Cancer Advanced Solid Tumors

Sponsor: Pheon Therapeutics

trial.available_in: БГ
Overview
This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-012, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.
Who can participate
Inclusion Criteria: * Has histologically confirmed, advanced/metastatic: 1. Colorectal adenocarcinoma (CRC), or 2. Non-small cell lung cancer (NSCLC), or 3. Pancreatic ductal adenocarcinoma (PDAC). * Has received at least one prior systemic therapy and radiologically or clinically determined progressive disease during or after the most recent line of therapy, and for whom no further standard therapy is available or who is intolerant to standard therapy. * Has measurable disease. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Has adequate organ function. * Has available tumor tissue sample at screening (either an archival specimen or fresh biopsy material). Exclusion Criteria: * Had prior treatment with any ADC containing topoisomerase-1 inhibiting payload. * Has unstable central nervous system metastasis. * Has persistent toxicities from previous systemic anti-cancer treatments of Grade \>1. * Has received systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the study drug. * Has received wide-field radiotherapy (\> 30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to first dose of the study drug, or no recovery from side effects of such intervention. * Had major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to first dose of the study drug, or no recovery from side effects of such intervention. * Has a history of non-infectious pneumonitis (NIP) / interstitial lung disease (ILD) requiring systemic steroids within 6 months prior to first dose of the study drug, active NIP / ILD or suspected NIP / ILD which cannot be ruled out by imaging for Screening.
Interventions
PHN-012
DRUG
Locations 21
Spain (10)
PHN-012-001 Site
Barcelona , Community of Catalonia
PHN-012-001 Site
Barcelona , Community of Catalonia
NOT_YET_RECRUITING
PHN-012-001 Site
Barcelona , Community of Catalonia
NOT_YET_RECRUITING
PHN-012-001 Site
Madrid , Madrid
NOT_YET_RECRUITING
PHN-012-001 Site
Madrid , Madrid
PHN-012-001 Site
Madrid , Madrid
NOT_YET_RECRUITING
PHN-012-001 Site
Madrid , Madrid
PHN-012-001 Site
Madrid , Madrid
PHN-012-001 Site
Valencia , Valencia
NOT_YET_RECRUITING
PHN-012-001 Site
Valencia , Valencia
United States (11)
PHN-012-001 Site
Boston , Massachusetts
PHN-012-001 Site
Durham , North Carolina
PHN-012-001 Site
Fairfax , Virginia
PHN-012-001 Site
Houston , Texas
PHN-012-001 Site
Los Angeles , California
PHN-012-001 Site
Nashville , Tennessee
PHN-012-001 Site
Portland , Oregon
PHN-012-001 Site
San Antonio , Texas
PHN-012-001 Site
San Diego , California
NOT_YET_RECRUITING
PHN-012-001 Site
St Louis , Missouri
PHN-012-001 Site
Washington D.C. , District of Columbia
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
23.09.2025
Completion date
01.05.2028
Registry ID
NCT07127874
Source
clinicaltrials.gov
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