PF-08634404 alone or with ipilimumab for adults with advanced hepatocellular carcinoma not removable by surgery
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
This tests PF-08634404 by itself and together with ipilimumab in adults whose hepatocellular carcinoma is advanced and cannot be removed surgically.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | ipilimumab |
| Locations | 11 sites (Reno, Nevada and 10 other locations) |
| Trial ID | NCT07227012 on ClinicalTrials.gov |
What this trial studies
This phase 1/2 interventional trial gives PF-08634404 intravenously either alone or combined with the checkpoint antibody ipilimumab to adults with locally advanced or metastatic hepatocellular carcinoma not amenable to curative surgery or locoregional therapy. Phase 1 focuses on safety, tolerability, and dose finding, followed by phase 2 to explore anti-tumor activity. Eligible participants must have measurable, untreated lesions, Child-Pugh A liver function, ECOG performance status 0–1, and no prior systemic therapy for HCC. Treatments are administered at clinical sites with monitoring during and after each infusion.
Who should consider this trial
Good fit: Adults (18+) with locally advanced or metastatic hepatocellular carcinoma not eligible for curative surgery or loco-regional therapy, Child-Pugh A, ECOG 0–1, at least one measurable untreated lesion, and no prior systemic HCC therapy are ideal candidates.
Not a fit: Patients with poorer liver function (Child-Pugh B/C), moderate to severe ascites, hepatic encephalopathy, active CNS metastases, prior systemic HCC treatment, or high bleeding/fistula risk are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the regimen could shrink tumors or slow disease progression and provide a new treatment option for patients with unresectable HCC.
How similar studies have performed: Other immune-based combinations have shown meaningful activity in HCC, so combining an investigational agent like PF-08634404 with ipilimumab builds on existing immunotherapy approaches though PF-08634404 itself is investigational.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Reno, Nevada and 10 other locations
- Renown Health Medical Oncology — Reno, Nevada, United States (Recruiting)
- Renown Office of Clinical Research — Reno, Nevada, United States (Recruiting)
- Renown Regional Medical Center — Reno, Nevada, United States (Recruiting)
- Aichi Cancer Center — Nagoya, Aichi-ken, Japan (Not_yet_recruiting)
- Kindai University Hospital- Osaka Medical Campus — Sakai, Osaka, Japan (Recruiting)
- National Hospital Organization Kyushu Cancer Center — Fukuoka, Japan (Recruiting)
- Pan American Center for Oncology Trials, LLC - Dorado Office — Dorado, United States of America, Puerto Rico (Recruiting)
- Pan American Center for Oncology Trials, LLC - Mayaguez Office — Mayagüez, United States of America, Puerto Rico (Recruiting)
- Pan American Center for Oncology Trials, LLC — Rio Piedras, Puerto Rico (Recruiting)
- Pan American Center for Oncology Trials, LLC — San Juan, Puerto Rico (Recruiting)
- Taipei Veterans General Hospital — Taipei, Taiwan (Not_yet_recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.