Consider a clinical trial for your patients who have unresectable, locally advanced, or metastatic hepatocellular carcinoma. Connect with a clinical trial site to learn more and see if your patients may be eligible.

This is an open-label Phase 1b/2 clinical trial exploring the safety, efficacy, and pharmacokinetics of the study drug (PF-08634404) as monotherapy and in combination with (ipilimumab) in participants with hepatocellular carcinoma.

The study consists of 2 phases:

  • Phase 1b (safety run-in): different doses of PF-08634404 and ipilimumab evaluated for safety and tolerability to select up to 2 recommended doses of the combination for expansion for Phase 2
  • Phase 2 (dose optimization/expansion): A PF-08634404 monotherapy arm initiated in addition to the recommended doses for expansion selected in Phase 1b

Participants may receive the study treatment until radiographically confirmed disease progression. After treatment ends, there will be an in-person follow-up visit then phone calls every 12 weeks for survival status and anticancer therapies being received.

To view all C646 clinical trials, click here

About the study medicine

The study medicine, PF-08634404, is a bispecific antibody drug that was designed to target both PD-1 and VEGF. This dual mechanism has the potential to achieve tumor immunosurveillance, while disrupting vascular support for tumor progression, compared with blocking either target alone in patients with solid tumors.

Preliminary clinical data with [(PF-08634404)] as a single agent and combined with chemotherapy shows encouraging results in patients with metastatic colorectal cancer and non-small cell lung cancer as well as other advanced solid tumors.1-3

Key eligibility criteria

  • Aged 18 years or older
  • Diagnosis of locally advanced or metastatic hepatocellular carcinoma confirmed by histology/cytology or clinically by AASLD criteria (for participants with cirrhosis), those without cirrhosis require histological confirmation of diagnosis
  • Have not received prior systemic therapy for their hepatocellular carcinoma
  • Have at least one measurable lesion per RECIST v1.1
  • No previous treatment with anti-VEGF inhibitor or immunotherapy

AASLD, American Association for the Study of Liver Diseases; RECIST, Response Evaluation Criteria in Solid Tumors.

Additional requirements apply. Only Principal Investigators can determine eligibility.

Study endpoints

TA trials

Primary endpoints

  • Dose-limiting toxicities (Phase 1b)
  • AEs as characterized by type, frequency, severity as graded by NCI CTCAE v5.0, timing, seriousness, and relationship to study intervention
  • Confirmed ORR per RECIST v1.1 by investigator (Phase 2)
check clipboard

Secondary endpoints

  • DOR per RECIST v1.1 as assessed by investigator
  • PFS per RECIST v1.1 as assessed by investigator
  • Confirmed ORR per RECIST v1.1 by investigator (Phase 1b)
  • Overall survival
  • Laboratory test abnormalities as characterized by type, frequency, severity as graded by NCI CTCAE v5.0, and timing
  • Predose and/or postdose concentrations of PF-08634404
  • Incidence of ADA against PF-08634404
about clinical trials

Note: This is not a complete list of study endpoints.

ADA, anti-drug antibodies; AE, adverse event; DOR, duration of response; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; ORR, objective response rate; PFS, progression-free survival.

Together, we can make a difference

People are often introduced to clinical trials through conversations with their healthcare providers. We appreciate you taking the time to have discussions with your patients and their loved ones who may be interested in contributing to research.

Should any of your patients take part in this clinical trial, they will remain under your medical care for all non-study-related needs.

Thank you for considering your patients for this important clinical trial.

Is this page helpful?
References
  1. Xu X, Li W, Liu T, et al. 796P A phase II trial to evaluate the safety and efficacy of SSGJ-707: A bispecific antibody targeting PD-1 and VEGF, in combination with chemotherapy in patients with metastatic CRC. Annals of Oncology. 2025;36. doi: 10.1016/j.annonc.2025.08.1369
  2. Wu L, Yao J, Sun Y., et al. A phase II trial to evaluate the safety and efficacy of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, as a monotherapy in patients with advanced NSCLC. Journal of Clinical Oncology. 2025;43(16_suppl): 8543. doi: 10.1200/JCO.2025.43.16_suppl.8543
  3. Wu L, Xu H, Sun Y, et al. 1328 SSGJ-707, a PD-1/VEGF bispecific antibody, combined with platinum-based chemotherapy in first-line treatment of advanced non-small cell lung cancer (NSCLC): Results from a phase 2 study. Journal for ImmunoTherapy of Cancer. 2025;13. doi:10.1136/jitc-2025-SITC2025.1328.