Clinical Trial 24009

• Overview

  Study Title:

  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

  Summary:

  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.

  Objective:

  Primary Objective * To evaluate the safety and tolerability of PF-08634404 in combination with ipilimumab. Secondary Objectives * To evaluate the antitumor efficacy of PF-08634404 in combination with ipilimumab. * To evaluate additional measurements of safety of PF-08634404 in combination with ipilimumab. * To evaluate the PK of PF-08634404 in combination with ipilimumab. * To evaluate the immunogenicity of PF-08634404 in combination with ipilimumab.

• Treatments

  Therapies:

  Bispecific antibody targeting PD-L1 and VEGF-A; Immunotherapy; anti-CTLA4 antibody

  Medications:

  Ipilimumab (); PF-08634404 (); Yervoy (Ipilimumab)

• Inclusion 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

• Exclusion Criteria

  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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