A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma

PHASE3RecruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

June 30, 2024

Primary Completion Date

December 30, 2026

Study Completion Date

December 31, 2027

Conditions
Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Interventions
DRUG

Irinotecan OR Paclitaxel or Trifluridine/tipiracil( FTD/TPI)

"Drugs: Irinotecan Subjects in the control arm will receive irnotecan 150mg/m2 IV D1, D15, Q4W in 4-weeks cycles.~Drugs: Paclitaxel Subjects in the control arm will receive paclitaxel 80mg/m2 IV D1, D8, D15, Q4W in 4-week cycles, Drugs:FTD/TPI Subjects in the control arm will receive FTD/TPI 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (applicable in US/EU/Japan and other regions where FTD/TPI is approved for GC treatment)."

DRUG

IBI343

Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles .

Trial Locations (22)

100142

RECRUITING

Beijing Cancer Hospital, Beijing

791-0280

RECRUITING

Shikoku Cancer Center, Matsuyama

373-8550

RECRUITING

Gunma Prefectural Cancer Center, Ota-Shi

737-0023

RECRUITING

Kure Medical Center And Chugoku Cancer Center, Kure

006-8555

RECRUITING

Teine Keijinkai Hospital, Sapporo

811-1395

RECRUITING

National Hospital Organization Kyushu Cancer Center, Fukuoka

673-8558

RECRUITING

Hyogo Cancer Center, Akashi

650-0047

RECRUITING

Kobe City Medical Center General Hospital, Kobe

216-8511

RECRUITING

St. Marianna University Hospital, Kawasaki

232-0024

RECRUITING

Yokohama City University Medical Center, Yokohama

Unknown

RECRUITING

Kanagawa Cancer Center, Yokohama

781-8555

RECRUITING

Kochi Health Sciences Center, Kochi

589-8511

RECRUITING

Kindai University Hospital, Osakasayama-Shi

565-0871

RECRUITING

The University of Osaka Hospital, Suita-shi

350-1298

RECRUITING

Saitama Medical University - International Medical Center, Hidaka-Shi

362-0806

RECRUITING

Saitama Prefectural Cancer Center, Kitaadachi-Gun

260-8717

RECRUITING

Chiba Cancer Center, Chiba

113-8655

RECRUITING

University of Tokyo Hospital, Bunkyō-Ku

113-8677

RECRUITING

Tokyo Metropolitan Komagome Hospital, Bunkyō-Ku

135-8550

RECRUITING

Cancer Institute Hospital of JFCR, Koto

501-1194

RECRUITING

Gifu University Hospital, Gifu

541-8567

RECRUITING

Osaka Prefectural Hospital Organization - Osaka International Cancer Institute, Osaka

All Listed Sponsors
lead

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY