Consider a clinical trial for your patients with locally advanced or metastatic renal cell carcinoma. Connect with a clinical trial site to learn more and see if your patients may be eligible.

This is a Phase 1b/2 clinical trial exploring the safety and efficacy of the study drug (PF-08634404) as a monotherapy or in combination with one of 2 approved anticancer drugs (ipilimumab or axitinib) in participants with locally advanced or metastatic renal cell carcinoma.

The clinical trial has 3 cohorts:

  • Cohort A: PF-08634404 monotherapy
  • Cohort B: PF-08634404 + ipilimumab
    • Dose escalation (Part 1)
    • Randomized dose optimization/expansion (Part 2)
  • Cohort C: PF-08634404 + axitinib
    • Dose escalation (Part 1)
    • Randomized dose optimization/escalation (Part 2)

Participants may receive study treatment until investigator assessed disease progression per RECIST v1.1, or other reasons (please see protocol for details). After treatment ends, there will be an in-person follow-up visit or phone call every 12 weeks for survival status and to review anticancer therapies being received.

RECIST, Response Evaluation Criteria in Solid Tumors.

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
  • Have histologically or cytologically confirmed diagnosis of advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with a clear cell component
  • Have had no prior systemic anticancer therapy for renal cell carcinoma other than adjuvant immunotherapy with last dose received >12 months before enrollment
  • Have at least one measurable lesion per RECIST v1.1

Additional requirements apply. Only Principal Investigators can determine eligibility.

Study endpoints

TA trials

Primary endpoints

  • Confirmed ORR per RECIST v1.1 by investigator
  • AEs as characterized by type, frequency, severity as graded by NCI CTCAE v5.0, timing, seriousness, and relationship to study intervention(s)
  • DLTs in the first cycle (Cohorts B and C, Part 1 only)
check clipboard

Key secondary endpoints

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

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

ADA, anti-drug antibody; AE, adverse event; DOR, duration of response; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0; 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.