drugset / Trial / NCT06577376

A PhaseⅠ/Ⅱ Study of Simmitinib or Irinotecan Liposomes Combined With DP303c in Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

NCT06577376

Phase 1/2 Not yet recruiting 252 enrolled Shanghai Runshi Pharmaceutical Technology Co., Ltd
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is divided into two parts: Cohort 1 and Cohort 2. Cohort 1 includes the dose escalation phase of DP303c combined with simmitinib, as well as the randomized controlled trial (RCT) phase of DP303c combined with simmitinib; Cohort 2 includes dose escalation/dose extension of DP303c combined with irinotecan liposomes, as well as RCT stage of DP303c combined with irinotecan liposomes.

Timeline

Start
2024-08-26
Primary completion
2026-08-26
Completion
2027-08-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule
Comparator Irinotecan Small molecule
Subject Irinotecan liposomes Unknown
Comparator Paclitaxel Small molecule
Subject Simmitinib Small molecule Oral
Subject TRASTUZUMAB ENVEDOTIN Monoclonal antibody Intravenous