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Recruiting NCT07392892

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

Phase II / Phase III Interventional Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma Metastatic Gastric Cancer Gastroesophageal Junction Cancer Esophageal Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PF-08634404, Chemotherapy, Nivolumab.
Who it may be relevant to
Registry conditions: Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma, Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, China, Israel, Italy, Japan +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Phase 2: Confirmed Objective response rate (ORR) using RECIST 1.1 as assessed by investigator [Time frame: Approximately 4 years]
  • Phase 2: Number of participants with treatment-emergent adverse events [Time frame: Through 90 days after the last study intervention; Approximately 4 years]
  • Phase 3: Progression Free Survival (PFS) using RECIST 1.1 as assessed by BICR [Time frame: Approximately 4 years]
  • Phase 3: Overall Survival (OS) [Time frame: Approximately 4 years]
Secondary outcome measures (12)
  • Phase 2: Duration of Response (DOR) using RECIST 1.1 as assessed by investigator [Time frame: Approximately 4 years]
  • Phase 2: Progression Free Survival (PFS) using RECIST 1.1 as assessed by investigator [Time frame: Approximately 4 years]
  • Phase 2: Overall Survival (OS) [Time frame: Approximately 4 years]
  • Phase 2: Number of participants with laboratory abnormalities [Time frame: Through 90 days after the last study intervention; Approximately 4 years]
  • Phase 2: Serum concentrations of PF-08634404 [Time frame: Approximately 21 months]
  • Phase 2: Incidence of Anti-Drug Antibody (ADA) against PF-08634404 [Time frame: Approximately 21 months]
  • Phase 3: ORR using RECIST 1.1 as assessed by BICR [Time frame: Approximately 4 years]
  • Phase 3: ORR using RECIST 1.1 as assessed by investigator [Time frame: Approximately 4 years]
  • Phase 3: Progression free survival (PFS) using RECIST 1.1 as assessed by investigator [Time frame: Approximately 4 years]
  • Phase 3: DOR using RECIST 1.1 as assessed by BICR [Time frame: Approximately 4 years]
  • Phase 3: DOR using RECIST 1.1 as assessed by investigator [Time frame: Approximately 4 years]
  • Phase 3: PFS2 (PFS after next-line therapy) by investigator [Time frame: Approximately 4 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 59 centers
  • Rocky Mountain Cancer Centers, LLP — Aurora
  • Rocky Mountain Cancer Centers, LLP — Boulder
  • Rocky Mountain Cancer Centers, LLP — Centennial
  • Rocky Mountain Cancer Centers, LLP — Colorado Springs
  • Rocky Mountain Cancer Centers, LLP — Colorado Springs
  • Rocky Mountain Cancer Centers, LLP — Denver
  • Rocky Mountain Cancer Centers, LLP — Denver
  • Rocky Mountain Cancer Centers, LLP — Englewood
  • … and 51 more centers
Israel · 3 centers
  • Rabin Medical Center — Petah Tikva
  • Sheba Medical Center — Ramat Gan
  • Sourasky Medical Center — Tel Aviv
Taiwan · 3 centers
  • National Cheng Kung University Hospital — Tainan
  • National Taiwan University Hospital — Taipei
  • Taipei Veterans General Hospital — Taipei
Puerto Rico · 2 centers
  • Pan American Center for Oncology Trials, LLC - Manati Office — Manati
  • Pan American Center for Oncology Trials, LLC - Bayamón Office — Bayamón
China · 1 center
  • Zhongshan Hospital,Fudan University — Shanghai
Italy · 1 center
  • Istituto Europeo di Oncologia IRCCS — Milan
Japan · 1 center
  • Aichi Cancer Center — Nagoya

Identifiers

NCT: NCT07392892 · C6461016 · 2025-524717-86-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗