AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 AS MONOTHERAPY AND COMBINATION THERAPY IN ADULT PARTICIPANTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA
Status: Recruiting
Location: See all (35) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Moffitt Cancer Center at Speros
RECRUITING
Land O' Lakes
Moffitt Cancer Center at SouthShore
RECRUITING
Ruskin
Moffitt Cancer Center
RECRUITING
Tampa
Moffitt Cancer Center - International Plaza
RECRUITING
Tampa
Moffitt Cancer Center - McKinley Campus
RECRUITING
Tampa
Moffitt McKinley Hospital
RECRUITING
Tampa
Moffitt Cancer Center at Wesley Chapel
RECRUITING
Wesley Chapel
Illinois
Memorial Hospital
NOT_YET_RECRUITING
Shiloh
Siteman Cancer Center - Shiloh
NOT_YET_RECRUITING
Shiloh
Minnesota
Allina Health Cancer Institute - Mercy Hospital
RECRUITING
Coon Rapids
Allina Health Cancer Institute - Abbott Northwestern Hospital
RECRUITING
Minneapolis
Allina Health Cancer Institute - United Hospital
RECRUITING
Saint Paul
Missouri
Siteman Cancer Center - St. Peters
NOT_YET_RECRUITING
City Of Saint Peters
Siteman Cancer Center - West County
NOT_YET_RECRUITING
Creve Coeur
Siteman Cancer Center - North County
NOT_YET_RECRUITING
Florissant
Barnes-Jewish Hospital
NOT_YET_RECRUITING
St Louis
Siteman Cancer Center
NOT_YET_RECRUITING
St Louis
Siteman Cancer Center - South County
NOT_YET_RECRUITING
St Louis
Washington University School of Medicine - Siteman Cancer Center
NOT_YET_RECRUITING
St Louis
Nevada
Renown Health Medical Oncology
RECRUITING
Reno
Renown Office of Clinical Research
RECRUITING
Reno
Renown Regional Medical Center
RECRUITING
Reno
Other Locations
Japan
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
National Cancer Center Hospital East
RECRUITING
Kashiwa
Aichi Cancer Center
RECRUITING
Nagoya
Kindai University Hospital- Osaka Medical Campus
RECRUITING
Sakai
Puerto Rico
Pan American Center for Oncology Trials, LLC - Dorado Office
RECRUITING
Dorado
Pan American Center for Oncology Trials, LLC - Mayaguez Office
RECRUITING
Mayagüez
Pan American Center for Oncology Trials, LLC - Ponce Office
RECRUITING
Ponce
Pan American Center for Oncology Trials, LLC
RECRUITING
Rio Piedras
Pan American Center for Oncology Trials, LLC
RECRUITING
San Juan
Taiwan
Taichung Veterans General Hospital
NOT_YET_RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date:2025-12-01
Estimated Completion Date:2028-10-17
Participants
Target number of participants:138
Treatments
Experimental: Phase 1b
Participants will be allocated to sequential dose levels of PF-08634404 and ipilimumab.
Experimental: Phase 2
Participants will be randomized to receive either PF-08634404 monotherapy or PF-08634404 combined with ipilimumab.