Trial: A Study to Learn About the Study Medici…

Trial Details

Sponsor: Pfizer (industry)

Phase: 3

Start date: Dec. 11, 2025

Planned enrollment: 800

Trial ID: NCT07222800

More trial details at ClinicalTrials.gov

Show Summary from Sponsor

The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have colorectal cancer that has spread to other parts of your body. * Be in good enough health to receive study treatment. * Should not be pregnant before starting treatment. Participants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects. The medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment. * The study is expected to last approximately 33 months for each participant. * Participants will have regular visits to the study site for treatment, health checks, and tests. * After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects. * Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.

Investigational Drug AI Analysis

Show for: PF-08634404 (SSGJ-707)

Overview

PF-08634404 (also referred to as SSGJ-707) is an investigational PD-1/VEGF bispecific antibody being developed for multiple solid tumors, including non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC). Clinical development has included Phase 2 studies in China (under the SSGJ-707 name) and Pfizer-sponsored global studies (under the PF-08634404 code).
Sources: ClinicalTrials.gov: NCT07222566, JITC abstract (2025 supplement)

Mechanism of action

Target(s): Programmed cell death protein 1 (PD-1) and vascular endothelial growth factor (VEGF).
Rationale: Dual blockade is intended to combine immune checkpoint inhibition (via PD-1) with anti-angiogenic effects (via VEGF).
Source: JCO (ASCO 2025) abstract record (ResearchGate mirror), DOI: 10.1200/JCO.2025.43.16_suppl.8543

Efficacy

First-line advanced NSCLC (SSGJ-707 + platinum-based chemotherapy; Phase 2, NCT06412471; data cutoff July 4, 2025)
Confirmed objective response rate (ORR) reported for the SSGJ-707 10 mg/kg Q3W regimen: - Nonsquamous NSCLC: ORR 58.6%
- Squamous NSCLC (cohort A): ORR 75.0%
- Squamous NSCLC (cohort B): ORR 69.2% with carboplatin + nab-paclitaxel; 37.5% with carboplatin + paclitaxel (noted as majority pending confirmation in the abstract)
Comparator arm (tislelizumab + chemotherapy) confirmed ORR: - Nonsquamous: 38.7% - Squamous: 47.6%
Source: JITC abstract (2025 supplement)

First-line advanced NSCLC (SSGJ-707 monotherapy; Phase 2, NCT06361927; interim results as of Jan 10, 2025)
In patients with treatment-naïve advanced NSCLC and PD-L1 expression ≥1%, the abstract reports (among evaluable patients) an ORR of: - 61.8% and disease control rate (DCR) 97.1% at 10 mg/kg Q3W (dose group sizes and evaluable counts are described in the abstract).
Source: JCO (ASCO 2025) abstract record (ResearchGate mirror), DOI: 10.1200/JCO.2025.43.16_suppl.8543

mCRC (SSGJ-707; Phase 2 trial registered; results not posted in the registry record)
A Phase 2 study evaluating first-line mCRC regimens including SSGJ-707 is registered, but no outcome results are posted in the record at this time.
Source: ClinicalTrials.gov: NCT06493760

Safety

First-line advanced NSCLC (SSGJ-707 + chemotherapy; Phase 2, NCT06412471; data cutoff July 4, 2025)
For the SSGJ-707 10 mg/kg arms across study parts: - Grade ≥3 treatment-related adverse events (TRAEs): 39.0% (vs 32.8% with tislelizumab + chemotherapy)
- TRAEs led to treatment discontinuation in 1.9% (2 patients)
- TRAEs associated with death in 2.9% (3 patients; hemoptysis in 2; unknown cause in 1)
Source: JITC abstract (2025 supplement)

Clinical development status (selected registered trials)

Global Phase 3 (Pfizer): PF-08634404 + chemotherapy vs pembrolizumab + chemotherapy in locally advanced/metastatic NSCLC (planned enrollment 1500; not yet recruiting as of last update posted Oct 30, 2025).
Source: ClinicalTrials.gov: NCT07222566
Phase 2 (China): SSGJ-707 in first-line mCRC (includes combination arms; no posted results)
Source: ClinicalTrials.gov: NCT06493760

TrialFetch AI Analysis

Goal: To determine whether adding the investigational PD-1/VEGF bispecific antibody PF-08634404 to standard first-line chemotherapy improves clinical outcomes versus bevacizumab plus the same chemotherapy in previously untreated metastatic colorectal cancer, while characterizing safety, pharmacokinetics, immunogenicity, and patient-reported quality of life.

Patients: Adults (≥18 years) with histologically/cytologically confirmed metastatic (stage IV) colorectal adenocarcinoma, ECOG performance status 0–1, at least one RECIST 1.1 measurable lesion, and adequate organ function. Key exclusions include locally confirmed BRAF V600E mutation, MSI-high/dMMR disease, active symptomatic CNS metastases, significant bleeding risk or recent grade ≥3 hemorrhage, recent major surgery/trauma, significant cardiovascular disease within 6 months, active autoimmune disease requiring systemic therapy within 2 years, and noninfectious/drug-induced ILD/pneumonitis.

Design: Phase 3, double-blind, randomized, active-controlled, multicenter study with planned enrollment of approximately 800 participants. Treatment is delivered in repeating IV cycles and may continue until disease progression, unacceptable toxicity, or discontinuation. Disease assessments include blinded independent central review (BICR) for key efficacy endpoints, with long-term follow-up for survival and subsequent therapy outcomes (overall follow-up up to ~4 years).

Treatments: Experimental arm: PF-08634404 administered intravenously in combination with standard chemotherapy for metastatic colorectal cancer (specific regimen not provided in the trial description). PF-08634404 (also known as SSGJ-707) is a bispecific antibody targeting PD-1 and VEGF, intended to couple immune checkpoint inhibition with anti-angiogenic effects. Early-phase experience has been reported mainly in first-line NSCLC, where combination with platinum chemotherapy showed higher objective response rates than a PD-1 inhibitor plus chemotherapy in a phase 2 report, with grade ≥3 treatment-related adverse events in the ~40% range; efficacy and safety in mCRC remain investigational and are being tested here against an established anti-VEGF standard. Comparator arm: bevacizumab (anti-VEGF monoclonal antibody) administered intravenously in combination with standard chemotherapy.

Outcomes: Co-primary endpoints are progression-free survival by BICR per RECIST 1.1 and overall survival. Key secondary endpoints include objective response rate and duration of response (each assessed by BICR and by investigator), investigator-assessed PFS, PFS2 (time to second progression after next-line therapy), treatment-emergent adverse events/serious adverse events, clinical laboratory abnormalities, pharmacokinetics of PF-08634404, anti-drug antibodies, and patient-reported outcomes (EORTC QLQ-C30 global health status/QoL, EORTC QLQ-CR29 symptom/function scales, and time to definitive deterioration).

Burden on patient: Moderate burden. Treatment requires regular on-site IV infusions consistent with standard first-line mCRC therapy, plus protocol-mandated efficacy imaging and assessments over a prolonged period (up to approximately 4 years) with blinded central review. Additional study-specific procedures include pharmacokinetic sampling and immunogenicity testing (anti-drug antibodies) over roughly the first 21 months, routine safety labs, and repeated quality-of-life questionnaires; follow-up continues every 12 weeks after treatment discontinuation, which adds ongoing visits or contact beyond typical care in some settings. No mandatory biopsies are described in the provided information.

Last updated: Jan 2026

Eligibility

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Status: Recruiting

AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER

Trial Details

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: PF-08634404 (SSGJ-707)

Overview

Mechanism of action

Efficacy

Safety

Clinical development status (selected registered trials)

Further reading

TrialFetch AI Analysis

Eligibility

Show Criteria

Sites (16)

Icon Cancer Centre Hobart

Icon Cancer Centre Wesley

Kyushu University Hospital

National Hospital Organization Osaka Medical Center

Saitama Medical University International Medical Center

Saitama Prefectural Cancer Center

The Cancer Institute Hospital of JFCR

Pan American Center for Oncology Trials, LLC

Cancer Care Centers of Brevard, Inc.

Mid Florida Hematology and Oncology Center

Hope and Healing Cancer Services

Illinois Cancer Care

Hematology Oncology Associates of Rockland

Oncology Associates of Oregon, P.C.

Texas Oncology - Northeast Texas

Texas Oncology - West Texas