NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	*Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma
Date of first enrollment	26/06/2026
Target sample size	840
Countries of recruitment	United States,Japan,Puerto Rico,Japan
Study type	Interventional
Intervention(s)	*Biological: PF-08634404 -Participants will receive PF-08634404 intravenously. -Other Names: #SSGJ-707 *Drug: Chemotherapy -Participants will receive PF-08634404 intravenously in combination with Chemotherapy. *Biological: Nivolumab -Participants will receive Nivolumab intravenously.

Outcome(s)

Primary Outcome

*Phase 2: Confirmed Objective response rate (ORR) using RECIST 1.1 as assessed by investigator [Time Frame: Approximately 4 years] -Confirmed ORR by investigator is defined as the proportion of participants with confirmed Complete Response (CR) or Partial Response (PR) per RECIST v1.1 as assessed by investigator. *Phase 2: Number of participants with treatment-emergent adverse events [Time Frame: Through 90 days after the last study intervention; Approximately 4 years] -Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention. *Phase 3: Progression Free Survival (PFS) using RECIST 1.1 as assessed by BICR [Time Frame: Approximately 4 years] -PFS by BICR is defined as the time from the date of randomization to the date of first documented disease progression per RECIST 1.1 as assessed by BICR, or death due to any cause, whichever occurs first. *Phase 3: Overall Survival (OS) [Time Frame: Approximately 4 years] -OS is defined as the time from the date of randomization to the date of death due to any cause.

Secondary Outcome

*Phase 2: Duration of Response (DOR) using RECIST 1.1 as assessed by investigator [Time Frame: Approximately 4 years] -DOR by investigator is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, respectively, or death due to any cause, whichever occurs first. *Phase 2: Progression Free Survival (PFS) using RECIST 1.1 as assessed by investigator [Time Frame: Approximately 4 years] -PFS by investigator is defined as the time from the date of first dose to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, or death due to any cause, whichever occurs first. *Phase 2: Overall Survival (OS) [Time Frame: Approximately 4 years] -OS is defined as the time from the date of first dose to the date of death due to any cause. *Phase 2: Number of participants with laboratory abnormalities [Time Frame: Through 90 days after the last study intervention; Approximately 4 years] -Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing. For laboratory tests without CTCAE grade definitions, results will be categorized as normal, high, low, or not done and be listed. *Phase 2: Serum concentrations of PF-08634404 [Time Frame: Approximately 21 months] -Predose and postdose concentrations of PF-08634404 *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] -ORR by BICR is defined as the proportion of participants with a Best Overall Response (BOR) of confirmed CR or confirmed PR per RECIST 1.1 as assessed by BICR. *Phase 3: ORR using RECIST 1.1 as assessed by investigator [Time Frame: Approximately 4 years] -ORR by investigator is defined as the proportion of participants with a BOR of confirmed CR or confirmed PR per RECIST 1.1 as assessed by investigator. *Phase 3: Progression free survival (PFS) using RECIST 1.1 as assessed by investigator [Time Frame: Approximately 4 years] -PFS by investigator is defined as the time from the date of randomization to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, or death due to any cause, whichever occurs first *Phase 3: DOR using RECIST 1.1 as assessed by BICR [Time Frame: Approximately 4 years] -DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST 1.1 as assessed by BICR, respectively, or death due to any cause, whichever occurs first. *Phase 3: DOR using RECIST 1.1 as assessed by investigator [Time Frame: Approximately 4 years] -DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, respectively, or death due to any cause, whichever occurs first. *Phase 3: PFS2 (PFS after next-line therapy) by investigator [Time Frame: Approximately 4 years] -PFS2 is defined as the time from the date of randomization to the date of second objective disease progression or death due to any cause, whichever occurs first *Phase 3: Number of participants with treatment-emergent adverse events [Time Frame: Through 90 days after the last study intervention; Approximately 4 years] -AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s) *Phase 3: Number of participants with laboratory abnormalities [Time Frame: Through 90 days after the last study intervention; Approximately 4 years] -Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing. For laboratory tests without CTCAE grade definitions, results will be categorized as normal, high, low, or not done and be listed. *Phase 3: Serum concentrations of PF-08634404 [Time Frame: Approximately 21 months] -Predose and postdose concentrations of PF-08634404 *Phase 3: Incidence of ADA against PF-08634404 [Time Frame: Approximately 21 months] *Phase 3: Change from baseline in Functional Assessment of Cancer Therapy - Gastric (FACT-Ga) Total score [Time Frame: Approximately 4 years] *Phase 3: Time to definitive deterioration in FACT-Ga Total score [Time Frame: Approximately 4 years] *Phase 3: Time to definitive deterioration in Gastric Cancer Subscale (GaCS) score [Time Frame: Approximately 4 years]

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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 *PD-L1 positive status
Exclude criteria	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