NIPH Clinical Trials Search

Pumitamigin Combination with Chemotherapy Versus Nivolumabin Combination with Chemotherapyin Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Advanced orMetastaticGastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
Date of first enrollment	17/02/2026
Target sample size	65
Countries of recruitment	Argentina,Japan,Australia,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,China,Japan,Colombia,Japan,France,Japan,Germany,Japan,India,Japan,Italy,Japan,Mexico,Japan,Poland,Japan,Romania,Japan,Republic of Korea,Japan,Spain,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan
Study type	Interventional
Intervention(s)	Pumitamig plus Chemotherapy arm Specified dose on specified days Nivolumab plus Chemotherapy arm Specified dose on specified days

Outcome(s)

Primary Outcome	Phase2: Objective Response (OR) Phase3: Progression-Free Survival (PFS), Overall Survival (OS)
Secondary Outcome	Phase2: PFS, Duration Of Response (DOR), Time To Response (TTR), Disease control, Recommended dose of pumitamig for Phase3 Phase3: OR, DOR

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	- Previously untreated with systemic treatment for advanced/metastatic disease, histologically or cytologically confirmed advanced or metastatic GC, GEJC or distal EAC. GEJ involvement can be confirmed via biopsy, endoscopy, or imaging. - Documented PD-L1 >= 1 as determined by the Sponsor pre-approved local PD-L1 IHC assays or through Sponsor-provided central laboratory testing. - Documented HER2-negative cancer, as determined according to local guidelines. - Measurable disease as defined by RECIST v1.1.
Exclude criteria	- Untreated known CNS metastases. - Significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis,cerebrovascular accident within 6 months prior to randomization,uncontrolled hypertension (>= 160 systolic, >= 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome. - Evidence of major coagulation disorders (eg, hemophilia). - History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (eg, inferior vena cava filter placed) and/or adequately anticoagulated on a prophylactic dose. - History of abdominal fistula or GI perforation within 6 months of randomization. - Major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study intervention