> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/symbiotic-gi-16-a-study-to-learn-about-the-study-medicine-f88d5a1d-bd05-49e5-a9f1-c0459dcb2b9f > Record changed: 2026-10-13 # Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer NCT07392892 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) Participants 840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) Lead sponsor Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) Start date 2026-05-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) Number of sites 74 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Short title** Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) ## Dates **Completion date** 2032-07-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **First posted** 2026-02-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Registry last updated** 2026-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Primary completion date** 2031-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Start date** 2026-05-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) ## Size and sites **Participants** 840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Planned participants** 840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Number of sites** 74 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Lead sponsor** Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) ## Identifiers **Registry ID** NCT07392892 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **ClinicalTrials.gov ID** NCT07392892 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masking description** Phase 2 is open-label, whereas Phase 3 is double-blind, randomized design **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) ## Outcomes ### Primary outcomes 1. Phase 2: Confirmed Objective response rate (ORR) using RECIST 1.1 as assessed by investigator Timeframe: 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. 2. Phase 2: Number of participants with treatment-emergent adverse events Timeframe: 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. 3. Phase 3: Progression Free Survival (PFS) using RECIST 1.1 as assessed by BICR Timeframe: 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. 4. Phase 3: Overall Survival (OS) Timeframe: Approximately 4 years OS is defined as the time from the date of randomization to the date of death due to any cause. ### Secondary outcomes 1. Phase 2: Duration of Response (DOR) using RECIST 1.1 as assessed by investigator Timeframe: 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. 2. Phase 2: Progression Free Survival (PFS) using RECIST 1.1 as assessed by investigator Timeframe: 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. 3. Phase 2: Overall Survival (OS) Timeframe: Approximately 4 years OS is defined as the time from the date of first dose to the date of death due to any cause. 4. Phase 2: Number of participants with laboratory abnormalities Timeframe: 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. 5. Phase 2: Serum concentrations of PF-08634404 Timeframe: Approximately 21 months Predose and postdose concentrations of PF-08634404 6. Phase 2: Incidence of Anti-Drug Antibody (ADA) against PF-08634404 Timeframe: Approximately 21 months 7. Phase 3: ORR using RECIST 1.1 as assessed by BICR Timeframe: 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. 8. Phase 3: ORR using RECIST 1.1 as assessed by investigator Timeframe: 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. 9. Phase 3: Progression free survival (PFS) using RECIST 1.1 as assessed by investigator Timeframe: 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 10. Phase 3: DOR using RECIST 1.1 as assessed by BICR Timeframe: 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. 11. Phase 3: DOR using RECIST 1.1 as assessed by investigator Timeframe: 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. 12. Phase 3: PFS2 (PFS after next-line therapy) by investigator Timeframe: 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 13. Phase 3: Number of participants with treatment-emergent adverse events Timeframe: 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) 14. Phase 3: Number of participants with laboratory abnormalities Timeframe: 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. 15. Phase 3: Serum concentrations of PF-08634404 Timeframe: Approximately 21 months Predose and postdose concentrations of PF-08634404 16. Phase 3: Incidence of ADA against PF-08634404 Timeframe: Approximately 21 months 17. Phase 3: Change from baseline in Functional Assessment of Cancer Therapy - Gastric (FACT-Ga) Total score Timeframe: Approximately 4 years 18. Phase 3: Time to definitive deterioration in FACT-Ga Total score Timeframe: Approximately 4 years 19. Phase 3: Time to definitive deterioration in Gastric Cancer Subscale (GaCS) score Timeframe: Approximately 4 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) ## Sites - Rocky Mountain Cancer Centers, LLPAurora, United StatesRecruiting - Rocky Mountain Cancer Centers, LLPBoulder, United StatesRecruiting - Rocky Mountain Cancer Centers, LLPCentennial, United StatesRecruiting - Rocky Mountain Cancer Centers, LLPColorado Springs, United StatesRecruiting - Rocky Mountain Cancer Centers, LLPColorado Springs, United StatesRecruiting - Rocky Mountain Cancer Centers, LLPDenver, United StatesRecruiting - Rocky Mountain Cancer Centers, LLPDenver, United StatesRecruiting - Rocky Mountain Cancer Centers, LLPEnglewood, United StatesRecruiting - Rocky Mountain Cancer Centers, LLPLakewood, United StatesRecruiting - Rocky Mountain Cancer Centers, LLPLittleton, United StatesRecruiting - Rocky Mountain Cancer Centers, LLPLone Tree, United StatesRecruiting - Rocky Mountain Cancer Centers, LLPLongmont, United StatesRecruiting - Rocky Mountain Cancer Centers, LLPPueblo, United StatesRecruiting - Rocky Mountain Cancer Centers, LLPThornton, United StatesRecruiting - Illinois Cancer SpecialistsArlington Heights, United StatesRecruiting - Illinois CancerCare - BloomingtonBloomington, United StatesRecruiting - Illinois Cancer SpecialistsChicago, United StatesRecruiting - Illinois CancerCare - GalesburgGalesburg, United StatesRecruiting - Illinois Cancer SpecialistsNiles, United StatesRecruiting - Illinois CancerCare-Ottawa-Fox River Cancer CenterOttawa, United StatesRecruiting - Illinois CancerCare-PekinPekin, United StatesRecruiting - Illinois CancerCare, P.C.Peoria, United StatesRecruiting - Illinois CancerCare-Peru - Valley Regional Cancer CenterPeru, United StatesRecruiting - Illinois CancerCare-WashingtonWashington, United StatesRecruiting - Maryland Oncology Hematology, P.A.Annapolis, United StatesRecruiting And 49 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C6461016) ### Other registry identifiers (2) - 2025 - 2025-524717-86-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07392892) ## Related records ### Drugs (1) - [Nivolumab](https://trialight.com/data/asset/nivolumab-d2e207ca-a7d1-43d0-987f-43ef7eef8f1b.md) ### Lead sponsors (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) ### Conditions (3) - [Esophageal adenocarcinoma](https://trialight.com/data/condition/esophageal-adenocarcinoma-4bf4a077-18f0-54cb-9a30-b8ea936afe32.md) - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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