PF-08634404

Shows activity

Also known as:

SSGJ-707

Cancer types include:

colon cancer non-small cell lung cancer rectal cancer small cell lung cancer

TrialFetch AI Analysis

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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

Active trials using PF-08634404

Found 3 active trials using this drug:

AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

Sponsor: Pfizer (industry) Phase: 3 Start date: Jan. 6, 2026

TrialFetch AI summary: Adults with unresectable stage IIIB/IIIC or metastatic stage IV squamous or non-squamous NSCLC without actionable driver alterations, systemic-therapy naïve for advanced disease (ECOG 0–1, measurable disease, known PD-L1 status), are randomized to PF-08634404/SSGJ-707 (investigational bispecific antibody targeting PD-1 and VEGF) plus histology-appropriate platinum-based chemotherapy followed by maintenance, versus pembrolizumab plus the same chemotherapy followed by standard maintenance. Primary outcomes compare overall survival and centrally reviewed PFS between regimens.

ClinicalTrials.gov ID: NCT07222566

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

Sponsor: Pfizer (industry) Phase: 3 Start date: Dec. 11, 2025

TrialFetch AI summary: Enrolls adults with previously untreated metastatic (stage IV) colorectal adenocarcinoma, ECOG 0–1, RECIST-measurable disease, adequate organ function, excluding MSI-high/dMMR or BRAF V600E tumors and patients with active symptomatic CNS metastases, significant bleeding/cardiovascular risk, or active autoimmune disease requiring systemic therapy. Compares PF-08634404 (SSGJ-707), a bispecific antibody targeting PD-1 and VEGF, plus standard first-line IV chemotherapy versus bevacizumab (anti-VEGF) plus the same chemotherapy, treating until progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT07222800

A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER

Sponsor: Pfizer (industry) Phase: 2/3 Start date: Dec. 9, 2025

TrialFetch AI summary: Enrolling adults with treatment-naïve extensive-stage small cell lung cancer (ECOG 0–1) and measurable disease, allowing prior curative-intent therapy for limited-stage SCLC if completed ≥6 months earlier, and excluding active CNS metastases/leptomeningeal disease and significant bleeding/fistula risk. Patients receive IV PF-08634404/SSGJ-707 (bispecific anti–PD-1/anti-VEGF antibody combining checkpoint inhibition with anti-angiogenic blockade) plus platinum/etoposide with possible maintenance, compared with atezolizumab plus the same chemotherapy backbone.

ClinicalTrials.gov ID: NCT07226999