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 (SSGJ-707) is an investigational bispecific antibody being studied for advanced cancers, including non-small cell lung cancer (NSCLC). Human phase 2 results have been reported, but the evidence remains preliminary: the principal findings are from conference abstracts, and a phase 3 NSCLC trial is intended to test the treatment more definitively. (ascopubs.org)

Mechanism of action

The antibody binds both PD-1, an immune checkpoint, and VEGF, a driver of blood-vessel growth. It is designed to combine PD-1 blockade with VEGF inhibition in one molecule. (ascopubs.org)

Efficacy

NSCLC, without chemotherapy: In a phase 2 study of previously untreated advanced disease with PD-L1 expression of at least 1%, the confirmed objective response rate was 67.6% among 34 patients receiving 10 mg/kg every three weeks. Median progression-free survival was 12.4 months; median overall survival had not been reached at the November 28, 2025, data cutoff. This treatment group had no comparator arm. (ascopubs.org)
NSCLC, with chemotherapy: An early randomized phase 2 study reported confirmed response rates of 58.6% with SSGJ-707 plus chemotherapy versus 38.7% with tislelizumab plus the same chemotherapy in the nonsquamous NSCLC groups (29 and 31 patients, respectively). These small, early groups do not establish a survival advantage. (jitc.bmj.com)
Other cancers: Early phase 2 abstracts have also reported responses with SSGJ-707 plus chemotherapy in metastatic colorectal and advanced or recurrent endometrial cancer. Because these are combination regimens, their results cannot isolate the drug’s contribution. (annalsofoncology.org)

Safety

In the NSCLC monotherapy study, 42.2% of 83 patients across dose groups had a treatment-related adverse event of grade 3 or higher. The most frequent were pneumonia (8.4%), hypertension (7.2%), and coughing up blood (hemoptysis; 6.0%). In the NSCLC chemotherapy study, grade 3 or higher treatment-related events occurred in 39.0% of patients receiving the 10 mg/kg SSGJ-707 regimen, versus 32.8% receiving tislelizumab; three treatment-related deaths were reported in the SSGJ-707 group, including two attributed to hemoptysis. Safety estimates may change with larger studies and longer follow-up. (ascopubs.org)

TrialFetch AI Analysis

Goal: Assess the safety and antitumor activity of PF-08634404 plus chemotherapy as first-line treatment for advanced gastroesophageal adenocarcinoma, then compare its efficacy with nivolumab plus chemotherapy.

Patients: Adults with locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma; HER2-negative and PD-L1-positive disease; ECOG performance status 0–1; and no prior systemic therapy for advanced disease. Key exclusions include active CNS metastases, significant bleeding risk, recent major surgery, clinically significant cardiovascular disease, active autoimmune disease requiring systemic treatment, and interstitial lung disease or pneumonitis.

Design: Two-part phase 2/3 study. Phase 2 evaluates PF-08634404 plus chemotherapy for response and safety; the randomized phase 3 portion compares that regimen with nivolumab plus chemotherapy. Treatment is given in repeated cycles.

Treatments: PF-08634404 (SSGJ-707) is an investigational bispecific antibody targeting PD-1 and VEGF, designed to combine immune-checkpoint blockade with inhibition of tumor-associated blood-vessel growth. Preliminary phase 2 NSCLC data have shown responses, including a 58.6% confirmed response rate with PF-08634404 plus chemotherapy versus 38.7% with tislelizumab plus chemotherapy in small nonsquamous cohorts; these results do not establish benefit in gastroesophageal cancer. Serious bleeding, including fatal hemoptysis, has been reported in early studies. Nivolumab is an approved PD-1 inhibitor given with chemotherapy as the active comparator.

Outcomes: Phase 2 primary measures are investigator-assessed confirmed objective response rate by RECIST 1.1 and treatment-emergent adverse events. Phase 3 primary measures are blinded independent central review–assessed progression-free survival and overall survival. Secondary measures include response and duration of response, additional survival measures, safety and laboratory abnormalities, PF-08634404 pharmacokinetics and anti-drug antibodies, and gastric cancer–specific quality of life.

Burden on patient: Moderate to high. Repeated treatment cycles and oncology visits, imaging for response assessment, laboratory and safety monitoring, and follow-up require ongoing time and travel. Participants receiving PF-08634404 also have predose and postdose blood sampling for pharmacokinetics and anti-drug antibodies; phase 3 participants complete quality-of-life assessments. No mandatory research biopsy or exact visit schedule is specified.

Last updated: Sep 2026

Eligibility

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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

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Rocky Mountain Cancer Centers, LLP

Denver, Colorado, 80218, United States

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Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, 80012, United States

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Rocky Mountain Cancer Centers, LLP

Denver, Colorado, 80220, United States

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Rocky Mountain Cancer Centers, LLP

Englewood, Colorado, 80113, United States

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Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Lakewood, Colorado, 80228, United States

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Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Littleton, Colorado, 80120, United States

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Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, 80124, United States

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Rocky Mountain Cancer Centers, LLP

Longmont, Colorado, 80504, United States

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Rocky Mountain Cancer Centers, LLP

Pueblo, Colorado, 81003, United States

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Rocky Mountain Cancer Centers, LLP

Thornton, Colorado, 80260, United States

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Rocky Mountain Cancer Centers, LLP

Boulder, Colorado, 80303, United States

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Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Centennial, Colorado, 80112, United States

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Status: Recruiting

Illinois Cancer Specialists

Chicago, Illinois, 60631, United States

No email / No phone

Status: Recruiting

Illinois Cancer Specialists

Niles, Illinois, 60714, United States

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Status: Recruiting

Illinois Cancer Specialists

Arlington Heights, Illinois, 60005, United States

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Status: Recruiting

Illinois CancerCare - Bloomington

Bloomington, Illinois, 61704, United States

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Status: Recruiting

Illinois CancerCare - Galesburg

Galesburg, Illinois, 61401, United States

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Status: Recruiting

Illinois CancerCare, P.C.

Peoria, Illinois, 61615, United States

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Illinois CancerCare-Ottawa-Fox River Cancer Center

Ottawa, Illinois, 61350, United States

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Status: Recruiting

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

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Status: Recruiting

Illinois CancerCare-Peru - Valley Regional Cancer Center

Peru, Illinois, 61354, United States

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Status: Recruiting

Illinois CancerCare-Washington

Washington, Illinois, 61571, United States

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Status: Recruiting

Maryland Oncology Hematology, P.A.

Largo, Maryland, 20774, United States

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Status: Recruiting

Maryland Oncology Hematology, P.A.

Annapolis, Maryland, 21401, United States

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Maryland Oncology Hematology, P.A.

Bethesda, Maryland, 20817, United States

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Maryland Oncology Hematology, P.A.

Brandywine, Maryland, 20613, United States

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Maryland Oncology Hematology, P.A.

Columbia, Maryland, 21044, United States

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Maryland Oncology Hematology, P.A.

Germantown, Maryland, 20876, United States

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Maryland Oncology Hematology, P.A.

Rockville, Maryland, 20850, United States

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Maryland Oncology Hematology, P.A.

Silver Spring, Maryland, 20904, United States

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Renown Health Medical Oncology

Reno, Nevada, 89502, United States

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Renown Office of Clinical Research

Reno, Nevada, 89502, United States

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Renown Regional Medical Center

Reno, Nevada, 89502, United States

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Status: Recruiting

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, 45242, United States

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Status: Recruiting

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, 45245, United States

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Status: Recruiting

Oncology Hematology Care Clinical Trials, LLC

Fairfield, Ohio, 45014, United States

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Status: Recruiting

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, 45211, United States

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Status: Recruiting

Alliance Cancer Specialists, PC

Doylestown, Pennsylvania, 18901, United States

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Status: Recruiting

Alliance Cancer Specialists, PC

Langhorne, Pennsylvania, 19047, United States

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Status: Recruiting

Alliance Cancer Specialists, PC

Media, Pennsylvania, 19063, United States

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Alliance Cancer Specialists, PC

Sellersville, Pennsylvania, 18960, United States

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Alliance Cancer Specialists, PC

Wynnewood, Pennsylvania, 19096, United States

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Status: Recruiting

Alliance Cancer Specialists, PC

Bensalem, Pennsylvania, 19020, United States

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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

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Status: Not yet recruiting

Virginia Cancer Specialists, PC

Manassas, Virginia, 20110, United States

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Status: Not yet recruiting

Virginia Cancer Specialists, PC

Reston, Virginia, 20190, United States

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Virginia Cancer Specialists, PC

Woodbridge, Virginia, 22191, United States

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Virginia Cancer Specialists, PC

Arlington, Virginia, 22201, United States

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Virginia Oncology Associates

Chesapeake, Virginia, 23320, United States

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Virginia Oncology Associates

Hampton, Virginia, 23666, United States

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Virginia Oncology Associates

Newport News, Virginia, 23606, United States

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Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

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Virginia Oncology Associates

Virginia Beach, Virginia, 23456, United States

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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

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