A Randomized，Multicenter, Open-Label，Phase II/III Study to Evaluate the Safety and Efficacy of Disitamab Vedotin Combined With Cadonilimab in Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma Who Have Progressed on r First-line Therapy

NCT06221748 Phase 2/Phase 3 RECRUITING

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.

Details

Lead sponsor	RemeGen Co., Ltd.
Phase	Phase 2/Phase 3
Status	RECRUITING
Enrolment	90
Start date	2024-02-22
Completion	2027-12

Conditions

• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma

Interventions

• Disitamab Vedotin Injection
• Cadonilimab Injection
• Paclitaxel Injection

Primary outcomes

• Objective remission rate (ORR) (Phase II) — Up to approximately 2 years
  ORR assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1)
• Percentage of Participants With Adverse Events (AEs)(Phase II) — Up to approximately 2 years
  Number of participants with adverse effects of treatment. Frequency and severity of adverse effects of treatment as assessed by NCI CTCAE v5.0
• Progression-Free Survival(PFS) （IRC）（ Phase III) — Up to approximately 2 years
  PFS was defined as the time from random assignment to the onset of disease progression (as assessed by the IRC according to RECIST v1.1 criteria) or death (whichever event occurs first)
• Overall Survival (OS)(Phase III) — Up to approximately 2 years
  OS was defined as the time from the date of randomization to the date of death from any cause.

Countries

China