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

Official record

Identifier

NCT07392892

Recruiting locations

countries

United StatesChinaIsraelItalyJapanPuerto RicoTaiwan

Interventions studied

PF-08634404ChemotherapyNivolumab

Lead sponsor

Pfizer

Target enrolment

840 participants

Study type

INTERVENTIONAL

Phase

Phase 2/3

Status

Recruiting

First posted

Feb 6, 2026

Last updated on the registry

Jul 30, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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

Indexed under

Esophageal Cancer