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RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07392892

Registry updated: 2026-10-13
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Description

This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to people with gastroesophageal cancer that is locally advanced (spread to nearby tissues) or has spread to other parts of the body. To join the study, participants must meet the following conditions: Be 18 years or older. Have locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma Be treatment naïve for advanced or metastatic disease Be in good physical condition and have healthy organs based on medical tests. The study has two parts: * In the first part, researchers will check how safe the study medicine in combination with chemotherapy is and how well people respond to it. * In the second part, they will compare study medicine plus chemotherapy to another approved treatment (nivolumab plus chemotherapy) to see which works better. The treatment will be given in repeated time periods called cycles.

Interventions

  • PF-08634404 (Biological)
    Participants will receive PF-08634404 intravenously.
  • Chemotherapy (Drug)
    Participants will receive PF-08634404 intravenously in combination with Chemotherapy.
  • Nivolumab (Biological)
    Participants will receive Nivolumab intravenously.

Eligibility criteria

Inclusion Criteria: * Histological or cytological confirmed gastric, gastroesophageal junction or esophageal adenocarcinoma. * Evidence of locally advanced or metastatic disease. * Eastern Cooperative Oncology Group performance status (ECOG) 0-1 * No prior systemic therapy for advanced or metastatic disease. * Adequate hepatic, liver, and renal function * HER-2 negative status based on local testing * PD-L1 positive status based on local testing Exclusion Criteria: * Participants with known active CNS metastases, including leptomeningeal, brainstem, meningeal, or spinal cord metastases or compression * Clinically significant risk of hemorrhage or fistula * Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study * History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. * Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events * Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose * Participants with active autoimmune diseases requiring systemic treatment within the past 2 years * Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis

Conditions

Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma Metastatic Gastric Cancer Gastroesophageal Junction Cancer Esophageal Adenocarcinoma

Locations

  • UCLA Hematology/Oncology - Atascadero — Atascadero, California, United States
  • UCLA Hematology/Oncology - Burbank — Burbank, California, United States
  • UCLA Hematology/Oncology - Encino — Encino, California, United States
  • UCLA Hematology/Oncology - Marina del Rey — Marina del Rey, California, United States
  • UCLA Hematology/Oncology - Porter Ranch — Porter Ranch, California, United States
  • UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
  • UCSF Investigational Drugs Pharmacy — San Francisco, California, United States
  • UCLA Hematology/Oncology - San Luis Obispo — San Luis Obispo, California, United States
  • UCLA Hematology/Oncology - Santa Barbara — Santa Barbara, California, United States
  • UCLA Hematology/Oncology - Santa Monica — Santa Monica, California, United States
  • Rocky Mountain Cancer Centers, LLP — Aurora, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Boulder, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Centennial, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Colorado Springs, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Colorado Springs, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Englewood, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Lakewood, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Littleton, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Lone Tree, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Longmont, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Pueblo, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Thornton, Colorado, United States
  • Florida Cancer Specialists — Daytona Beach, Florida, United States
  • Florida Cancer Specialists — Fleming Island, Florida, United States
  • Florida Cancer Specialists — Palm Beach Gardens, Florida, United States
  • Florida Cancer Specialists — Sebring, Florida, United States
  • Florida Cancer Specialists — Wellington, Florida, United States
  • Florida Cancer Specialists — West Palm Beach, Florida, United States
  • Illinois Cancer Specialists — Arlington Heights, Illinois, United States
  • Illinois CancerCare - Bloomington — Bloomington, Illinois, United States
  • Illinois Cancer Specialists — Chicago, Illinois, United States
  • Illinois CancerCare - Galesburg — Galesburg, Illinois, United States
  • Illinois Cancer Specialists — Niles, Illinois, United States
  • Illinois CancerCare-Ottawa-Fox River Cancer Center — Ottawa, Illinois, United States
  • Illinois CancerCare-Pekin — Pekin, Illinois, United States
  • Illinois CancerCare, P.C. — Peoria, Illinois, United States
  • Illinois CancerCare-Peru - Valley Regional Cancer Center — Peru, Illinois, United States
  • Illinois CancerCare-Washington — Washington, Illinois, United States
  • Maryland Oncology Hematology, P.A. — Annapolis, Maryland, United States
  • Maryland Oncology Hematology, P.A. — Bethesda, Maryland, United States
  • Maryland Oncology Hematology, P.A. — Brandywine, Maryland, United States
  • Maryland Oncology Hematology, P.A. — Columbia, Maryland, United States
  • Maryland Oncology Hematology, P.A. — Germantown, Maryland, United States
  • Maryland Oncology Hematology, P.A. — Largo, Maryland, United States
  • Maryland Oncology Hematology, P.A. — Rockville, Maryland, United States
  • Maryland Oncology Hematology, P.A. — Silver Spring, Maryland, United States
  • Renown Health Medical Oncology — Reno, Nevada, United States
  • Renown Office of Clinical Research — Reno, Nevada, United States
  • Renown Regional Medical Center — Reno, Nevada, United States
  • Atlantic Health System — Morristown, New Jersey, United States
  • Atlantic Health System / Overlook Medical Center — Summit, New Jersey, United States
  • Memorial Sloan Kettering Cancer Center Pharmacy (IMP ship to address) — Long Island City, New York, United States
  • Memorial Sloan Kettering Cancer Center Pharmacy (IMP storage location) — Long Island City, New York, United States
  • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). — New York, New York, United States
  • Rockefeller Outpatient Pavilion (53rd Street) — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center - Main Campus — New York, New York, United States
  • Oncology Hematology Care Clinical Trials, LLC — Cincinnati, Ohio, United States
  • Oncology Hematology Care Clinical Trials, LLC — Cincinnati, Ohio, United States
  • Oncology Hematology Care Clinical Trials, LLC — Cincinnati, Ohio, United States
  • Oncology Hematology Care Clinical Trials, LLC — Fairfield, Ohio, United States
  • Alliance Cancer Specialists, PC — Bensalem, Pennsylvania, United States
  • Alliance Cancer Specialists, PC — Doylestown, Pennsylvania, United States
  • Alliance Cancer Specialists, PC — Horsham, Pennsylvania, United States
  • Alliance Cancer Specialists, PC — Langhorne, Pennsylvania, United States
  • Alliance Cancer Specialists, PC — Media, Pennsylvania, United States
  • Alliance Cancer Specialists, PC — Sellersville, Pennsylvania, United States
  • Alliance Cancer Specialists, PC — Wynnewood, Pennsylvania, United States
  • US Oncology Investigational Products Center (IPC) — Irving, Texas, United States
  • Virginia Cancer Specialists, PC — Arlington, Virginia, United States
  • Virginia Oncology Associates — Chesapeake, Virginia, United States
  • Virginia Cancer Specialists, PC — Fairfax, Virginia, United States
  • Virginia Oncology Associates — Hampton, Virginia, United States
  • Virginia Cancer Specialists, PC — Manassas, Virginia, United States
  • Virginia Oncology Associates — Newport News, Virginia, United States
  • Virginia Oncology Associates — Norfolk, Virginia, United States
  • Virginia Cancer Specialists, PC — Reston, Virginia, United States
  • Virginia Oncology Associates — Virginia Beach, Virginia, United States
  • Virginia Cancer Specialists, PC — Woodbridge, Virginia, United States
  • Harborview Medical Center — Seattle, Washington, United States
  • Fred Hutchinson Cancer Center — Seattle, Washington, United States
  • University of Washington Medical Center — Seattle, Washington, United States
  • London Health Sciences Centre - Verspeeten Family Cancer Centre — London, Ontario, Canada
  • The Sixth Affiliated hospital, Sun Yat-sen University — Guangzhou, Guangdong, China
  • Hubei Cancer Hospital — Wuhan, Hubei, China
  • Zhongshan Hospital,Fudan University — Shanghai, Shanghai Municipality, China
  • Sichuan Cancer hospital — Chengdu, Sichuan, China
  • Hôpital Européen Georges Pompidou — Paris, France
  • Rabin Medical Center — Petah Tikva, Central District, Israel
  • Sheba Medical Center — Ramat Gan, HA Merkaz, Israel
  • Sourasky Medical Center — Tel Aviv, TELL ABĪB, Israel
  • Istituto Europeo di Oncologia IRCCS — Milan, Italy
  • Aichi Cancer Center — Nagoya, Aichi-ken, Japan
  • Pan American Center for Oncology Trials, LLC - Manati Office — Manati, United States, Puerto Rico
  • Pan American Center for Oncology Trials, LLC - Bayamón Office — Bayamón, Puerto Rico
  • Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [barcelona], Spain
  • Hospital Universitario 12 de Octubre — Madrid, Madrid, Comunidad de, Spain
  • Complexo Hospitalario Universitario de Ourense — Ourense, Ourense [orense], Spain
  • National Cheng Kung University Hospital — Tainan, Taiwan
  • National Taiwan University Hospital — Taipei, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record