New hope for liver cancer: pfizer tests experimental drug
NCT ID NCT07227012
First seen Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 8 times
Summary
This study tests a new drug called PF-08634404, given alone or with another drug (ipilimumab), in adults with advanced liver cancer that cannot be surgically removed. The goal is to check safety, side effects, and whether the drug shrinks tumors. About 138 participants will receive the treatment through IV infusions at clinical trial sites.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PF-08634404 (a biologic drug) and ipilimumab (also known as Yervoy)
- What this could lead to
- If successful, this could lead to a new treatment option for people with advanced liver cancer that cannot be removed by surgery.
- What could go wrong
- This is an early-phase trial (Phase 1b/2) with a small number of participants, so the drug may not prove effective or safe enough for wider use. Side effects are possible, and the combination with ipilimumab may increase risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 138 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
54 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aichi Cancer Center
RECRUITINGNagoya, Aichi-ken, 464-8681, Japan
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Allina Health Cancer Institute - Abbott Northwestern Hospital
RECRUITINGMinneapolis, Minnesota, 55407, United States
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Allina Health Cancer Institute - Mercy Hospital
RECRUITINGCoon Rapids, Minnesota, 55433, United States
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Allina Health Cancer Institute - United Hospital
RECRUITINGSaint Paul, Minnesota, 55102, United States
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Barnes-Jewish Hospital
RECRUITINGSt Louis, Missouri, 63110, United States
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Chao Family Comprehensive Cancer Center and Ambulatory Care
RECRUITINGIrvine, California, 92612, United States
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Duke Cancer Center
RECRUITINGDurham, North Carolina, 27710, United States
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Duke Cancer Center - Investigational Chemotherapy Service
RECRUITINGDurham, North Carolina, 27710, United States
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Duke Cancer Center Cary
RECRUITINGCary, North Carolina, 27518, United States
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Duke Cancer Center Raleigh
RECRUITINGRaleigh, North Carolina, 27609, United States
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Duke University - Main Hospital and Clinics
RECRUITINGDurham, North Carolina, 27710, United States
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Fred Hutchinson Cancer Center
RECRUITINGSeattle, Washington, 98109, United States
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Keck Hospital of USC
RECRUITINGLos Angeles, California, 90033, United States
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Keck Medical Center of USC Pasadena
RECRUITINGPasadena, California, 91105, United States
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Kindai University Hospital- Osaka Medical Campus
RECRUITINGSakai, Osaka, 590-0197, Japan
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Los Angeles General Medical Center
RECRUITINGLos Angeles, California, 90033, United States
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Memorial Hospital
RECRUITINGShiloh, Illinois, 62269, United States
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
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Moffitt Cancer Center - International Plaza
RECRUITINGTampa, Florida, 33607, United States
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Moffitt Cancer Center - McKinley Campus
RECRUITINGTampa, Florida, 33612, United States
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Moffitt Cancer Center at SouthShore
RECRUITINGRuskin, Florida, 33570, United States
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Moffitt Cancer Center at Speros
RECRUITINGLand O' Lakes, Florida, 34638, United States
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Moffitt Cancer Center at Wesley Chapel
RECRUITINGWesley Chapel, Florida, 33544, United States
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Moffitt McKinley Hospital
RECRUITINGTampa, Florida, 33612, United States
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National Cancer Center Hospital
RECRUITINGChuo-ku, Tokyo, 104-0045, Japan
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National Cancer Center Hospital East
RECRUITINGKashiwa, Chiba, 277-8577, Japan
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National Cheng Kung University Hospital
RECRUITINGTainan, 704, Taiwan
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National Hospital Organization Kyushu Cancer Center
RECRUITINGFukuoka, 811-1395, Japan
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National Taiwan University Hospital
RECRUITINGTaipei, 10002, Taiwan
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Pan American Center for Oncology Trials, LLC
RECRUITINGSan Juan, 00909, Puerto Rico
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Pan American Center for Oncology Trials, LLC - Dorado Office
RECRUITINGDorado, United States of America, 00646, Puerto Rico
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Pan American Center for Oncology Trials, LLC - Mayaguez Office
RECRUITINGMayagüez, United States of America, 00680, Puerto Rico
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Pan American Center for Oncology Trials, LLC - Ponce Office
RECRUITINGPonce, United States of America, 00730, Puerto Rico
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Renown Health Medical Oncology
RECRUITINGReno, Nevada, 89502, United States
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Renown Office of Clinical Research
RECRUITINGReno, Nevada, 89502, United States
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Renown Regional Medical Center
RECRUITINGReno, Nevada, 89502, United States
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Saint Luke's Cancer Institute
RECRUITINGKansas City, Missouri, 64111, United States
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Saint Luke's Hospital of Kansas City
RECRUITINGKansas City, Missouri, 64111, United States
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Siteman Cancer Center
RECRUITINGSt Louis, Missouri, 63108, United States
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Siteman Cancer Center - North County
RECRUITINGFlorissant, Missouri, 63031, United States
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Siteman Cancer Center - Shiloh
RECRUITINGShiloh, Illinois, 62269, United States
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Siteman Cancer Center - South County
RECRUITINGSt Louis, Missouri, 63129, United States
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Siteman Cancer Center - St. Peters
RECRUITINGCity of Saint Peters, Missouri, 63376, United States
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Siteman Cancer Center - West County
RECRUITINGCreve Coeur, Missouri, 63141, United States
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Taichung Veterans General Hospital
RECRUITINGTaichung, 407, Taiwan
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Taipei Veterans General Hospital
RECRUITINGTaipei, 112, Taiwan
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UC Irvine Health - Chao Family Comprehensive Cancer Center
RECRUITINGOrange, California, 92868, United States
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UCI Health - Irvine
RECRUITINGIrvine, California, 92612, United States
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UCI Health - Irvine Infusion Pharmacy ACC
RECRUITINGIrvine, California, 92612, United States
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USC/Norris Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90033, United States
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USC/Norris Comprehensive Cancer Center / Investigational Drug Services
RECRUITINGLos Angeles, California, 90033, United States
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University of Washington Medical Center- Montlake
RECRUITINGSeattle, Washington, 98195, United States
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Virginia Mason Medical Center
NOT_YET_RECRUITINGSeattle, Washington, 98101, United States
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Washington University School of Medicine - Siteman Cancer Center
RECRUITINGSt Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a computer model read MRI scans to predict which liver cancer patients will relapse?
- New antibody drug conjugate tested against advanced cancers
- Sparing the liver: targeted chemoembolization meets lenvatinib in liver cancer
- AI-Enhanced ultrasound aims to catch liver cancer earlier
- Can scans predict which liver cancer patients need extra local therapy?
- Can turbocharged immune cells stop liver cancer from coming back?