*Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma
Conditions
Interventions
*Biological: PF-08634404
-Participants will receive PF-08634404 intravenously.
-Other Names:
#SSGJ-707
*Drug: Chemotherapy
-Participants will receive PF-08634404 intravenously in combination with Chem
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *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
| Measure | Time frame |
|---|---|
| *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 | — |
Countries
Japan, Puerto Rico, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed