NCT06577376 - A PhaseⅠ/Ⅱ Study of Simmitinib or Irinotecan Liposomes Combined With DP303c in Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma | Biotech Hunter

Enrollment

252

Participants

Timeline

Start Date

August 26, 2024

Primary Completion Date

August 26, 2026

Study Completion Date

August 26, 2027

Conditions

Localized Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction AdenocarcinomaExpressing Human Epidermal Growth Factor Receptor-2 (HER-2)Disease Progression After Receiving at Least One and at Most Two Lines of Systemic Treatment in the Past

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.

All Listed Sponsors

lead

Shanghai Runshi Pharmaceutical Technology Co., Ltd

INDUSTRY