IBI343 Combined With Sintilimab Plus Chemotherapy in Previously Untreated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (Dragon15)
IBI343 Combined With Sintilimab Plus Chemotherapy in Previously Untreated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (Dragon15)
This is a Single-arm, Open-label, Phase 1b/2 Study of IBI343 Combined with Sintilimab Plus Chemotherapy in Previously Untreated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
This trial is a phase Ib/II study to evaluate the safety, tolerability and efficacy of IBI343 in combination with sintilimab and chemotherapy in patients with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. In dose-escalation stage, patients with CLDN 18.2-positive, HER2-negative were treated with IBI 343, sintilimab, and chemotherapy (oxaliplatin, S-1) as first-line therapy, which followed a 3+3 design. The dose expansion stage aimed to further investigate the safety and preliminary efficacy of recommended phase II dose (RP2D), including Cohort 1 and Cohort 2. In Cohort 1, 25 patients with CLDN18.2-positive, HER2-negative advanced G/GEJ adenocarcinoma will be enrolled. In Cohort 2, 15 patients with CLDN18.2-positive, HER2-negative gastric signet-ring cell carcinoma will be enrolled.
Inclusion Criteria:
1. Able and willing to sign a written Informed Consent Form (ICF) and to comply with protocol-specified visits and related procedures.
2. Age was 18-75 years at the time of signing the ICF, and gender was unlimited.
3. Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).
4. No received systemic therapy. 5. Has histopathologically confirmed CLDN18.2-positive disease. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Exclusion Criteria:
1. Has HER2-positive (defined as immunohistochemistry [IHC] 3+, or IHC 2+ and positive by in situ hybridization) disease.
2. Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study.
3. Has a history of treatment with topoisomerase inhibitor-based antibody-drug conjugate(s).
sm11998@rjh.com.cn021-64370045