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NOT YET RECRUITING
NCT06577376
PHASE1/PHASE2

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

Sponsor: Shanghai Runshi Pharmaceutical Technology Co., Ltd

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Open-label Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Simmitinib or Irinotecan Liposomes Combined With DP303c Injection in the Treatment of HER2 Expressing Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

252

Start Date

2024-08-26

Completion Date

2027-08-26

Last Updated

2024-09-05

Healthy Volunteers

No

Interventions

DRUG

DP303c

DP303c is an antibody conjugate drug (ADC), composed of one anti-HER2 monoclonal antibody coupled to one MMAE via an enzyme specific linker

DRUG

Simmitinib tablets

A novel small molecule inhibitor targeting fibroblast growth factor receptor (FGFR), vascular endothelial growth factor receptor (VEGFR2, KDR), and colony-stimulating factor 1 receptor (CSF-1R)

DRUG

Irinotecan liposomes

A chemotherapy

DRUG

Paclitaxel or docetaxel or irinotecan

Paclitaxel or docetaxel or irinotecan is used as a control.