Trial: A Study to Learn About the Study Medici…

Trial Details

Sponsor: Pfizer (industry)

Phase: 2/3

Start date: Feb. 6, 2026

Planned enrollment: 840

Trial ID: NCT07392892

More trial details at ClinicalTrials.gov

Show Summary from Sponsor

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 evaluate whether adding PF-08634404 to chemotherapy is safe and active in the first-line treatment of locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, and to determine in the phase 3 portion whether PF-08634404 plus chemotherapy improves outcomes compared with nivolumab plus chemotherapy.

Patients: The trial enrolls adults with histologically or cytologically confirmed gastric, gastroesophageal junction, or esophageal adenocarcinoma that is locally advanced or metastatic. Eligible patients must be treatment-naïve for advanced or metastatic disease, have ECOG performance status 0–1, adequate organ function, HER2-negative disease, and PD-L1-positive disease by local testing. Key exclusions include active CNS metastases, clinically significant bleeding or fistula risk, recent major surgery or trauma, significant cardiovascular comorbidity, active autoimmune disease requiring recent systemic therapy, prior allogeneic transplant, and noninfectious or drug-induced interstitial lung disease/pneumonitis.

Design: This is a randomized, industry-sponsored phase 2/3 interventional treatment study. The phase 2 portion evaluates PF-08634404 plus chemotherapy for safety, tolerability, and preliminary antitumor activity. The phase 3 portion randomizes patients to PF-08634404 plus chemotherapy versus nivolumab plus chemotherapy, with efficacy assessed by RECIST 1.1, including blinded independent central review for key phase 3 endpoints. Treatment is administered in repeated cycles and follow-up continues for approximately 4 years.

Treatments: The experimental regimen is PF-08634404 in combination with chemotherapy. PF-08634404, also known as SSGJ-707, is an investigational bispecific antibody targeting PD-1 and VEGF, designed to combine immune checkpoint blockade with anti-angiogenic activity. Early phase 2 data in advanced NSCLC have reported encouraging response rates, including confirmed ORRs around 59%–75% in first-line chemotherapy combinations at 10 mg/kg every 3 weeks, with grade ≥3 treatment-related adverse events reported in approximately 39% and rare treatment-related deaths including hemoptysis; efficacy and safety in gastroesophageal adenocarcinoma remain investigational. The active comparator regimen is nivolumab plus chemotherapy, an established first-line immunotherapy-based approach for selected patients with advanced HER2-negative gastroesophageal adenocarcinoma.

Outcomes: In phase 2, the primary endpoints are investigator-assessed confirmed objective response rate by RECIST 1.1 and treatment-emergent adverse events. Phase 2 secondary endpoints include duration of response, progression-free survival, overall survival, laboratory abnormalities, PF-08634404 serum concentrations, and anti-drug antibodies. In phase 3, the primary endpoints are blinded independent central review-assessed progression-free survival and overall survival. Phase 3 secondary endpoints include objective response rate, investigator-assessed PFS, duration of response, PFS2, safety and laboratory abnormalities, PF-08634404 pharmacokinetics and immunogenicity, and patient-reported outcomes using FACT-Ga and Gastric Cancer Subscale measures.

Burden on patient: The patient burden is moderate. Treatment requires recurrent clinic visits for intravenous study therapy and chemotherapy, similar to standard first-line chemoimmunotherapy, with routine laboratory monitoring, adverse-event assessments, and serial radiographic tumor assessments over a prolonged follow-up period. Additional burden comes from protocol-specific blood sampling for PF-08634404 pharmacokinetics and anti-drug antibody testing, and completion of quality-of-life questionnaires in the phase 3 portion. No mandatory on-treatment biopsy is specified, which keeps the burden below that of more intensive translational or early phase dose-escalation studies.

Last updated: May 2026

Eligibility

Show Criteria

Sites (58)

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Rocky Mountain Cancer Centers, LLP

Colorado Springs, Colorado, 80907, United States

No email / No phone

Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Colorado Springs, Colorado, 80923, United States

No email / No phone

Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, 80218, United States

No email / No phone

Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, 80012, United States

No email / No phone

Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, 80220, United States

No email / No phone

Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Englewood, Colorado, 80113, United States

No email / No phone

Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Lakewood, Colorado, 80228, United States

No email / No phone

Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Littleton, Colorado, 80120, United States

No email / No phone

Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, 80124, United States

No email / No phone

Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Longmont, Colorado, 80504, United States

No email / No phone

Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Pueblo, Colorado, 81003, United States

No email / No phone

Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Thornton, Colorado, 80260, United States

No email / No phone

Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Boulder, Colorado, 80303, United States

No email / No phone

Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Centennial, Colorado, 80112, United States

No email / No phone

Status: Recruiting

Illinois Cancer Specialists

Chicago, Illinois, 60631, United States

No email / No phone

Status: Recruiting

Illinois Cancer Specialists

Niles, Illinois, 60714, United States

No email / No phone

Status: Recruiting

Illinois Cancer Specialists

Arlington Heights, Illinois, 60005, United States

No email / No phone

Status: Recruiting

Illinois CancerCare - Bloomington

Bloomington, Illinois, 61704, United States

No email / No phone

Status: Recruiting

Illinois CancerCare - Galesburg

Galesburg, Illinois, 61401, United States

No email / No phone

Status: Recruiting

Illinois CancerCare, P.C.

Peoria, Illinois, 61615, United States

No email / No phone

Status: Recruiting

Illinois CancerCare-Ottawa-Fox River Cancer Center

Ottawa, Illinois, 61350, United States

No email / No phone

Status: Recruiting

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

No email / No phone

Status: Recruiting

Illinois CancerCare-Peru - Valley Regional Cancer Center

Peru, Illinois, 61354, United States

No email / No phone

Status: Recruiting

Illinois CancerCare-Washington

Washington, Illinois, 61571, United States

No email / No phone

Status: Recruiting

Maryland Oncology Hematology, P.A.

Largo, Maryland, 20774, United States

No email / No phone

Status: Recruiting

Maryland Oncology Hematology, P.A.

Annapolis, Maryland, 21401, United States

No email / No phone

Status: Recruiting

Maryland Oncology Hematology, P.A.

Bethesda, Maryland, 20817, United States

No email / No phone

Status: Recruiting

Maryland Oncology Hematology, P.A.

Brandywine, Maryland, 20613, United States

No email / No phone

Status: Recruiting

Maryland Oncology Hematology, P.A.

Columbia, Maryland, 21044, United States

No email / No phone

Status: Recruiting

Maryland Oncology Hematology, P.A.

Germantown, Maryland, 20876, United States

No email / No phone

Status: Recruiting

Maryland Oncology Hematology, P.A.

Rockville, Maryland, 20850, United States

No email / No phone

Status: Recruiting

Maryland Oncology Hematology, P.A.

Silver Spring, Maryland, 20904, United States

No email / No phone

Status: Recruiting

Renown Health Medical Oncology

Reno, Nevada, 89502, United States

No email / No phone

Status: Recruiting

Renown Office of Clinical Research

Reno, Nevada, 89502, United States

No email / No phone

Status: Recruiting

Renown Regional Medical Center

Reno, Nevada, 89502, United States

No email / No phone

Status: Recruiting

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, 45242, United States

No email / No phone

Status: Recruiting

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, 45245, United States

No email / No phone

Status: Recruiting

Oncology Hematology Care Clinical Trials, LLC

Fairfield, Ohio, 45014, United States

No email / No phone

Status: Recruiting

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, 45211, United States

No email / No phone

Status: Recruiting

Alliance Cancer Specialists, PC

Doylestown, Pennsylvania, 18901, United States

No email / No phone

Status: Recruiting

Alliance Cancer Specialists, PC

Langhorne, Pennsylvania, 19047, United States

No email / No phone

Status: Recruiting

Alliance Cancer Specialists, PC

Media, Pennsylvania, 19063, United States

No email / No phone

Status: Recruiting

Alliance Cancer Specialists, PC

Sellersville, Pennsylvania, 18960, United States

No email / No phone

Status: Recruiting

Alliance Cancer Specialists, PC

Wynnewood, Pennsylvania, 19096, United States

No email / No phone

Status: Recruiting

Alliance Cancer Specialists, PC

Bensalem, Pennsylvania, 19020, United States

No email / No phone

Status: Recruiting

US Oncology Investigational Products Center (IPC)

Irving, Texas, 75063, United States

No email / No phone

Status: Recruiting

Pan American Center for Oncology Trials, LLC - Manati Office

Manati, United States, 00674, Puerto Rico

No email / No phone

Status: Not yet recruiting

US Oncology Investigational Products Center (IPC)

Irving, Texas, 75063, United States

No email / No phone

Status: Not yet recruiting

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

No email / No phone

Status: Not yet recruiting

Virginia Cancer Specialists, PC

Manassas, Virginia, 20110, United States

No email / No phone

Status: Not yet recruiting

Virginia Cancer Specialists, PC

Reston, Virginia, 20190, United States

No email / No phone

Status: Not yet recruiting

Virginia Cancer Specialists, PC

Woodbridge, Virginia, 22191, United States

No email / No phone

Status: Not yet recruiting

Virginia Cancer Specialists, PC

Arlington, Virginia, 22201, United States

No email / No phone

Status: Not yet recruiting

Virginia Oncology Associates

Chesapeake, Virginia, 23320, United States

No email / No phone

Status: Not yet recruiting

Virginia Oncology Associates

Hampton, Virginia, 23666, United States

No email / No phone

Status: Not yet recruiting

Virginia Oncology Associates

Newport News, Virginia, 23606, United States

No email / No phone

Status: Not yet recruiting

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

No email / No phone

Status: Not yet recruiting

Virginia Oncology Associates

Virginia Beach, Virginia, 23456, United States

No email / No phone

Status: Not yet recruiting

A PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA

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 (58)

Rocky Mountain Cancer Centers, LLP

Rocky Mountain Cancer Centers, LLP

Rocky Mountain Cancer Centers, LLP

Rocky Mountain Cancer Centers, LLP

Rocky Mountain Cancer Centers, LLP

Rocky Mountain Cancer Centers, LLP

Rocky Mountain Cancer Centers, LLP

Rocky Mountain Cancer Centers, LLP

Rocky Mountain Cancer Centers, LLP

Rocky Mountain Cancer Centers, LLP

Rocky Mountain Cancer Centers, LLP

Rocky Mountain Cancer Centers, LLP

Rocky Mountain Cancer Centers, LLP

Rocky Mountain Cancer Centers, LLP

Illinois Cancer Specialists

Illinois Cancer Specialists

Illinois Cancer Specialists

Illinois CancerCare - Bloomington

Illinois CancerCare - Galesburg

Illinois CancerCare, P.C.

Illinois CancerCare-Ottawa-Fox River Cancer Center

Illinois CancerCare-Pekin

Illinois CancerCare-Peru - Valley Regional Cancer Center

Illinois CancerCare-Washington

Maryland Oncology Hematology, P.A.

Maryland Oncology Hematology, P.A.

Maryland Oncology Hematology, P.A.

Maryland Oncology Hematology, P.A.

Maryland Oncology Hematology, P.A.

Maryland Oncology Hematology, P.A.

Maryland Oncology Hematology, P.A.

Maryland Oncology Hematology, P.A.

Renown Health Medical Oncology

Renown Office of Clinical Research

Renown Regional Medical Center

Oncology Hematology Care Clinical Trials, LLC

Oncology Hematology Care Clinical Trials, LLC

Oncology Hematology Care Clinical Trials, LLC

Oncology Hematology Care Clinical Trials, LLC

Alliance Cancer Specialists, PC

Alliance Cancer Specialists, PC

Alliance Cancer Specialists, PC

Alliance Cancer Specialists, PC

Alliance Cancer Specialists, PC

Alliance Cancer Specialists, PC

US Oncology Investigational Products Center (IPC)

Pan American Center for Oncology Trials, LLC - Manati Office

US Oncology Investigational Products Center (IPC)

Virginia Cancer Specialists, PC

Virginia Cancer Specialists, PC

Virginia Cancer Specialists, PC

Virginia Cancer Specialists, PC

Virginia Cancer Specialists, PC

Virginia Oncology Associates

Virginia Oncology Associates

Virginia Oncology Associates

Virginia Oncology Associates

Virginia Oncology Associates