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New treatment option for Carcinoma, Hepatocellular
Official title 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.
ClinicalTrials.gov ID: NCT07227012
What this study is testing
What is PF-08634404?
PF-08634404 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for carcinoma, hepatocellular.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)...
- 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
You likely can't join if
- 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.
See the full eligibility 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...
- 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
- 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...
- Participants with acute, chronic or symptomatic infections.
- Participants with history of immunodeficiency.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Pasadena, California, United States
- Land O' Lakes, Florida, United States
- Ruskin, Florida, United States
- Tampa, Florida, United States
- Wesley Chapel, Florida, United States
- Shiloh, Illinois, United States
- Coon Rapids, Minnesota, United States
- Minneapolis, Minnesota, United States
- Saint Paul, Minnesota, United States
- City of Saint Peters, Missouri, United States
- Creve Coeur, Missouri, United States
- Florissant, Missouri, United States
- St Louis, Missouri, United States
- Reno, Nevada, United States
- Seattle, Washington, United States
- Nagoya, Aichi-ken, Japan
- Kashiwa, Chiba, Japan
- Sakai, Osaka, Japan
- Fukuoka, Japan
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Pasadena, California, United States; Land O' Lakes, Florida, United States; Ruskin, Florida, United States; Tampa, Florida, United States; Wesley Chapel, Florida, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.