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Recruiting Phase 1/2 NCT07227012

Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.

Phase 1/2 – combined early trial
Conditions: Carcinoma, Hepatocellular Hepatocellular Cancer Hepatocellular Carcinoma Unresectable Hepatocellular Carcinoma Liver Neoplasms Advanced Hepatocellular Carcinoma Metastatic Hepatocellular Carcinoma

Sponsor: Pfizer

trial.available_in: БГ
Overview
The purpose of this study is to learn about the effects of study medicine (PF-08634404) when given alone or with another antibody (ipilimumab) for the treatment of a type of liver cancer called hepatocellular carcinoma (HCC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have locally advanced or metastatic HCC. * Is not a candidate for complete surgical or loco-regional therapies. * Have not received any whole-body treatment for HCC. Participants will receive PF-08634404 either alone or in combination with ipilimumab. The medicine will be given through intravenous (IV) infusions, which means it will be administered directly into a vein. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.
Who can participate
Inclusion Criteria: * 18 years of age or older at screening. * Locally advanced or metastatic HCC with diagnosis confirmed by histology/cytology or clinically by AASLD criteria (for patients with cirrhosis). Participants without cirrhosis require histological confirmation of diagnosis. * Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and/or locoregional therapies. * At least 1 measurable (as defined by RECIST 1.1 per investigator) and untreated lesion. * Adequate hepatic, liver, and renal function * No prior systemic therapy for HCC. * ECOG performance status 0 or 1 * Child-Pugh Class A Key Exclusion Criteria: * Moderate or severe ascites. * History of hepatic encephalopathy. * Participants with known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression. * Clinically significant risk of hemorrhage or fistula. * Participants with any history of another malignancy within 3 years. * History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. * Participants with active autoimmune diseases requiring systemic treatment within the past 2 years. * Clinically significant cardiovascular disease within 6 months prior to the first dose. * Major surgery or severe trauma within 4 weeks prior to the first dose or planned major surgery during the study. * History of severe bleeding tendency or coagulation dysfunction. * History of severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding, including bleeding event due to esophageal and/or gastric varices, within 6 months prior to the first dose. * Participants with acute, chronic or symptomatic infections. * Participants with history of immunodeficiency.
Interventions
PF-08634404
BIOLOGICAL
Ipilimumab
BIOLOGICAL
Locations 11
Japan (3)
National Hospital Organization Kyushu Cancer Center
Fukuoka
Aichi Cancer Center
Nagoya , Aichi-ken
NOT_YET_RECRUITING
Kindai University Hospital- Osaka Medical Campus
Sakai , Osaka
Puerto Rico (4)
Pan American Center for Oncology Trials, LLC - Dorado Office
Dorado , United States of America
Pan American Center for Oncology Trials, LLC - Mayaguez Office
Mayagüez , United States of America
Pan American Center for Oncology Trials, LLC
Rio Piedras
Pan American Center for Oncology Trials, LLC
San Juan
Taiwan (1)
Taipei Veterans General Hospital
Taipei
NOT_YET_RECRUITING
United States (3)
Renown Health Medical Oncology
Reno , Nevada
Renown Office of Clinical Research
Reno , Nevada
Renown Regional Medical Center
Reno , Nevada
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.12.2025
Completion date
17.10.2028
Registry ID
NCT07227012
Source
clinicaltrials.gov
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