NCT07227012RecruitingPhase 1/2
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.
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- First submitted
- 7 Nov 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 18 Oct 2027
- Lead sponsor
- Pfizer
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07227012
- EU CT number
- 2025-523525-17-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 138
- From 1 Dec 2025 to the primary completion date, 18 Oct 2027
- 80 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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.
Other illness
- History of hepatic encephalopathy.
- 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.
- History of severe bleeding tendency or coagulation dysfunction.
- Participants with acute, chronic or symptomatic infections.
- Participants with history of immunodeficiency.
Other
- Moderate or severe ascites.
- Participants with known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (80)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Completed |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Completed |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Completed |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Not yet recruiting |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Not yet recruiting |
| Hospices Civils De Lyon Coordinator of this site? Confirm its status | Lyon Cedex 04 | France | Not yet recruiting |
| Centre De Lutte Contre Le Cancer Eugene Marquis Coordinator of this site? Confirm its status | Rennes Cedex | France | Not yet recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Not yet recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Not yet recruiting |
| Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS Coordinator of this site? Confirm its status | Candiolo | Italy | Not yet recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Not yet recruiting |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Recruiting |
| National Hospital Organization Kyushu Cancer Center Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| Aichi Cancer Center Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Kindai University Hospital- Osaka Medical Campus Coordinator of this site? Confirm its status | Sakai | Japan | Recruiting |
| Pan American Center for Oncology Trials, LLC- Dorado Office Coordinator of this site? Confirm its status | Dorado | Puerto Rico | Recruiting |
| Pan American Center for Oncology Trials, LLC - Mayaguez Office Coordinator of this site? Confirm its status | Mayagüez | Puerto Rico | Recruiting |
| Pan American Center for Oncology Trials, LLC - Ponce Office Coordinator of this site? Confirm its status | Ponce | Puerto Rico | Recruiting |
| Pan American Center for Oncology Trials LLC Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Recruiting |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Duke Cancer Center Cary Coordinator of this site? Confirm its status | Cary | United States | Recruiting |
| Siteman Cancer Center - St Peters Coordinator of this site? Confirm its status | City of Saint Peters | United States | Recruiting |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Allina Health Cancer Institute - Mercy Hospital Coordinator of this site? Confirm its status | Coon Rapids | United States | Recruiting |
| Siteman Cancer Center - West County Coordinator of this site? Confirm its status | Creve Coeur | United States | Recruiting |
| Duke Cancer Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Duke University - Main Hospital and Clinics Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Duke Cancer Center - Investigational Chemotherapy Service Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Siteman Cancer Center - North County Coordinator of this site? Confirm its status | Florissant | United States | Recruiting |
| UCI Health - Irvine Infusion Pharmacy ACC Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| UCI Health-Irvine Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Chao Family Comprehensive Cancer Center and Ambulatory Care Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Saint Luke's Hospital of Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Saint Luke's Cancer Institute Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Moffitt Cancer Center at Speros Coordinator of this site? Confirm its status | Land O' Lakes | United States | Recruiting |
| USC/Norris Comprehensive Cancer Center/Investigational Drug Services Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Los Angeles General Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| LACN Century City Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Keck Hospital of USC Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| START Los Angeles, LLC Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Allina Health Cancer Institute - Abbott Northwestern Hospital Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| UC Irvine Health- Chao Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Keck Medical Center of USC Pasadena Coordinator of this site? Confirm its status | Pasadena | United States | Recruiting |
| AHN Allegheny General Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| AHN Cancer Institute at Allegheny General Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Duke Cancer Center Raleigh Coordinator of this site? Confirm its status | Raleigh | United States | Recruiting |
| Renown Regional Medical Center Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Renown Health Medical Oncology Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Renown Office of Clinical Research Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Moffitt Cancer Center at SouthShore Coordinator of this site? Confirm its status | Ruskin | United States | Recruiting |
| Allina Health Cancer Institute - United Hospital Coordinator of this site? Confirm its status | Saint Paul | United States | Recruiting |
| University of Washington Medical Center - Montlake Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Virginia Mason Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Siteman Cancer Center - Shiloh Coordinator of this site? Confirm its status | Shiloh | United States | Recruiting |
| Memorial Hospital Coordinator of this site? Confirm its status | Shiloh | United States | Recruiting |
| Siteman Cancer Center-South County Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Siteman Cancer Center Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Barnes-Jewish Hospital Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Washington University School of Medicine - Siteman Cancer Center Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Moffitt McKinley Hospital Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Moffitt Cancer Center-International Plaza Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Moffitt Cancer Center - McKinley Campus Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Moffitt Cancer Center at Wesley Chapel Coordinator of this site? Confirm its status | Wesley Chapel | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.