Sign in

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
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

Full criteria on ClinicalTrials.gov

Sites (80)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhongshan Hospital,Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Charite Universitaetsmedizin Berlin KöR
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Universitaetsklinikum Bonn AöR
Coordinator of this site? Confirm its status
BonnGermanyCompleted
Universitaetsklinikum Duesseldorf AöR
Coordinator of this site? Confirm its status
DuesseldorfGermanyCompleted
Universitaetsklinikum Erlangen AöR
Coordinator of this site? Confirm its status
ErlangenGermanyCompleted
Medizinische Hochschule Hannover
Coordinator of this site? Confirm its status
HanoverGermanyCompleted
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Coordinator of this site? Confirm its status
MainzGermanyCompleted
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainNot yet recruiting
Hospital Universitario HM Sanchinarro
Coordinator of this site? Confirm its status
MadridSpainNot yet recruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainNot yet recruiting
Hospital Universitario Central De Asturias
Coordinator of this site? Confirm its status
OviedoSpainNot yet recruiting
Centr Georges Francois Leclerc
Coordinator of this site? Confirm its status
DijonFranceNot yet recruiting
Hospices Civils De Lyon
Coordinator of this site? Confirm its status
Lyon Cedex 04FranceNot yet recruiting
Centre De Lutte Contre Le Cancer Eugene Marquis
Coordinator of this site? Confirm its status
Rennes CedexFranceNot yet recruiting
Institut Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceNot yet recruiting
Azienda Ospedaliero-Universitaria delle Marche
Coordinator of this site? Confirm its status
AnconaItalyNot yet recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Coordinator of this site? Confirm its status
BolognaItalyNot yet recruiting
Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS
Coordinator of this site? Confirm its status
CandioloItalyNot yet recruiting
Ospedale San Raffaele S.r.l.
Coordinator of this site? Confirm its status
MilanItalyNot yet recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Coordinator of this site? Confirm its status
NaplesItalyNot yet recruiting
Humanitas Mirasole S.p.A.
Coordinator of this site? Confirm its status
RozzanoItalyNot yet recruiting
National Cancer Center Hospital
Coordinator of this site? Confirm its status
Chuo KuJapanRecruiting
National Hospital Organization Kyushu Cancer Center
Coordinator of this site? Confirm its status
FukuokaJapanRecruiting
National Cancer Center Hospital East
Coordinator of this site? Confirm its status
KashiwaJapanRecruiting
Aichi Cancer Center
Coordinator of this site? Confirm its status
NagoyaJapanRecruiting
Kindai University Hospital- Osaka Medical Campus
Coordinator of this site? Confirm its status
SakaiJapanRecruiting
Pan American Center for Oncology Trials, LLC- Dorado Office
Coordinator of this site? Confirm its status
DoradoPuerto RicoRecruiting
Pan American Center for Oncology Trials, LLC - Mayaguez Office
Coordinator of this site? Confirm its status
MayagüezPuerto RicoRecruiting
Pan American Center for Oncology Trials, LLC - Ponce Office
Coordinator of this site? Confirm its status
PoncePuerto RicoRecruiting
Pan American Center for Oncology Trials LLC
Coordinator of this site? Confirm its status
San JuanPuerto RicoRecruiting
Taichung Veterans General Hospital
Coordinator of this site? Confirm its status
TaichungTaiwanRecruiting
National Cheng Kung University Hospital
Coordinator of this site? Confirm its status
TainanTaiwanRecruiting
National Taiwan University Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Taipei Veterans General Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Duke Cancer Center Cary
Coordinator of this site? Confirm its status
CaryUnited StatesRecruiting
Siteman Cancer Center - St Peters
Coordinator of this site? Confirm its status
City of Saint PetersUnited StatesRecruiting
University Hospitals Cleveland Medical Center*
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting
Allina Health Cancer Institute - Mercy Hospital
Coordinator of this site? Confirm its status
Coon RapidsUnited StatesRecruiting
Siteman Cancer Center - West County
Coordinator of this site? Confirm its status
Creve CoeurUnited StatesRecruiting
Duke Cancer Center
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting
Duke University - Main Hospital and Clinics
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting
Duke Cancer Center - Investigational Chemotherapy Service
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting
Siteman Cancer Center - North County
Coordinator of this site? Confirm its status
FlorissantUnited StatesRecruiting
UCI Health - Irvine Infusion Pharmacy ACC
Coordinator of this site? Confirm its status
IrvineUnited StatesRecruiting
UCI Health-Irvine
Coordinator of this site? Confirm its status
IrvineUnited StatesRecruiting
Chao Family Comprehensive Cancer Center and Ambulatory Care
Coordinator of this site? Confirm its status
IrvineUnited StatesRecruiting
Saint Luke's Hospital of Kansas City
Coordinator of this site? Confirm its status
Kansas CityUnited StatesRecruiting
Saint Luke's Cancer Institute
Coordinator of this site? Confirm its status
Kansas CityUnited StatesRecruiting
Moffitt Cancer Center at Speros
Coordinator of this site? Confirm its status
Land O' LakesUnited StatesRecruiting
USC/Norris Comprehensive Cancer Center/Investigational Drug Services
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Los Angeles General Medical Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
LACN Century City
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Keck Hospital of USC
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
START Los Angeles, LLC
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
USC / Norris Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Allina Health Cancer Institute - Abbott Northwestern Hospital
Coordinator of this site? Confirm its status
MinneapolisUnited StatesRecruiting
UC Irvine Health- Chao Family Comprehensive Cancer Center
Coordinator of this site? Confirm its status
OrangeUnited StatesRecruiting
Keck Medical Center of USC Pasadena
Coordinator of this site? Confirm its status
PasadenaUnited StatesRecruiting
AHN Allegheny General Hospital
Coordinator of this site? Confirm its status
PittsburghUnited StatesRecruiting
AHN Cancer Institute at Allegheny General Hospital
Coordinator of this site? Confirm its status
PittsburghUnited StatesRecruiting
Duke Cancer Center Raleigh
Coordinator of this site? Confirm its status
RaleighUnited StatesRecruiting
Renown Regional Medical Center
Coordinator of this site? Confirm its status
RenoUnited StatesRecruiting
Renown Health Medical Oncology
Coordinator of this site? Confirm its status
RenoUnited StatesRecruiting
Renown Office of Clinical Research
Coordinator of this site? Confirm its status
RenoUnited StatesRecruiting
Moffitt Cancer Center at SouthShore
Coordinator of this site? Confirm its status
RuskinUnited StatesRecruiting
Allina Health Cancer Institute - United Hospital
Coordinator of this site? Confirm its status
Saint PaulUnited StatesRecruiting
University of Washington Medical Center - Montlake
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
Fred Hutchinson Cancer Center
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
Virginia Mason Medical Center
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
Siteman Cancer Center - Shiloh
Coordinator of this site? Confirm its status
ShilohUnited StatesRecruiting
Memorial Hospital
Coordinator of this site? Confirm its status
ShilohUnited StatesRecruiting
Siteman Cancer Center-South County
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Siteman Cancer Center
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Barnes-Jewish Hospital
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Washington University School of Medicine - Siteman Cancer Center
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Moffitt McKinley Hospital
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting
Moffitt Cancer Center-International Plaza
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting
Moffitt Cancer Center - McKinley Campus
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting
Moffitt Cancer Center
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting
Moffitt Cancer Center at Wesley Chapel
Coordinator of this site? Confirm its status
Wesley ChapelUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.