Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment a… (NCT07227012) | Clinical Trial Compass
RecruitingPhase 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.
United States, Japan, Puerto Rico138 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dysfunc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Adverse Events
Timeframe: Through end of study and up to approximately 24 months
2
Phase 1b: Number of participants with Dose limiting toxicities (DLT)
Timeframe: Through 90 days after the last dose of study intervention; Approximately 24 months
3
Phase 2: Confirmed Overall Response Rate (ORR) using RECIST 1.1 as assessed by investigator
Timeframe: Approximately 24 months
4
Phase 2: Recommended dose of PF-08634404 in combination with ipilimumab