Consider a clinical trial for your patients with treatment-naïve metastatic colorectal cancer. Connect with a clinical trial site to learn more and see if your patients may be eligible.
This is a phase 3, double-blind, randomized clinical trial exploring the efficacy and safety of the study drug, (PF-08634404) in combination with chemotherapy versus the comparator drug (bevacizumab) in combination with chemotherapy in participants with treatment-naïve metastatic colorectal cancer.
Approximately 800 participants will be randomized 1:1 to one of the following groups:
- Experimental arm: PF-08634404 + chemotherapy
- Control arm: bevacizumab + chemotherapy
Participants may receive the study treatment until objective disease progression per blinded independent central review (BICR). However, if a clinical benefit is observed, participants may continue treatment beyond progression. After treatment ends, there will be an in-person follow-up visit, phone call, or review of medical information every 12 weeks for survival status and anticancer therapies being received.
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 in combination with mFOLFOX6 shows encouraging results in patients with first-line mCRC.1
Key eligibility criteria
- Aged 18 years or older
- Have Stage IV colorectal cancer
- Known RAS mutation status per local test
- At least one measurable lesion per RECIST 1.1
- No prior systemic therapy for metastatic disease
- Do not have MSI-H/dMMR tumors
- Do not have BRAF V600E mutation
- No prior exposure to anti-VEGF therapy or cancer immunotherapy
Additional requirements apply. Only Principal Investigators can determine eligibility.
Study endpoints
Primary endpoints
- Progression-free survival (PFS) by BICR
- Overall survival
Key secondary endpoints
- PFS and PFS2 by investigator
- ORR and DOR by BICR and by investigator
Safety endpoints
- AEs as characterized by type, frequency, severity as graded by NCI CTCAE v5.0, timing, seriousness, and relationship to study intervention(s)
- Laboratory test abnormalities as characterized by type, frequency, severity as graded by NCI CTCAE v5.0, and timing
Note: This is not a complete list of study endpoints.
AE, adverse event; BICR, blinded independent central review; DOR, duration of response; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; ORR, objective response rate; PFS, progression-free survival; PFS2, PFS on next-line therapy.
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.
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