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.

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • PF-08634404
  • Ipilimumab

Treatment groups

138 Participants
are divided into 2 treatment groups

Locations

35
Japan
Aichi Cancer Center464-8681, NagoyaAichi-ken, Japan
National Cancer Center Hospital East277-8577, KashiwaChiba, Japan
Kindai University Hospital- Osaka Medical Campus590-0197, SakaiOsaka, Japan
National Hospital Organization Kyushu Cancer Center811-1395, Fukuoka Japan

Sponsors and collaborators

Pfizer

Lead sponsor