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.
Key facts
- Where
- Ancona, Bologna, Candiolo, Milan, Naples, and Rozzano, ItalySee the 6 sites
- Phase
- Phase 1/2
Where in Italy
- Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyNot yet recruiting
- Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCSCandiolo, ItalyNot yet recruiting
- Ospedale San Raffaele S.r.l.Milan, ItalyNot yet recruiting
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyNot yet recruiting
- Humanitas Mirasole S.p.A.Rozzano, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT07227012EU 2025-523525-17-00
- Record updated
- 8 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; 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; Moderate or severe ascites; Participants with known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.