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
Study ID
NCT06577376
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • DP303c — DRUG
    DP303c is an antibody conjugate drug (ADC), composed of one anti-HER2 monoclonal antibody coupled to one MMAE via an enzyme specific linker
  • Simmitinib tablets — DRUG
    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)
  • Irinotecan liposomes — DRUG
    A chemotherapy
  • Paclitaxel or docetaxel or irinotecan — DRUG
    Paclitaxel or docetaxel or irinotecan is used as a control.

Study Details

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.

Key Dates

Start date
Aug 26, 2024
Status verified
Aug 2024
Primary completion
Aug 26, 2026
Completion
Aug 26, 2027

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DP303c injection, dose level 1, Q3W + simmitinib tablets, dose level 1, D1-D21, Q4W
    DP303c injection, dose level 1, intravenous drip, Q3W + simmitinib tablets, dose level 1, oral, QD, taken for 3 weeks, discontinued for 1 week, Q4W
  • Experimental: DP303c injection, dose level 1, Q3W + simmitinib tablets, dose level 2, D1-D21, Q4W
    DP303c injection, dose level 1, intravenous drip, Q3W + simmitinib tablets, dose level 2, oral, QD, taken for 3 weeks, discontinued for 1 week, Q4W
  • Experimental: DP303c injection, dose level 1, Q2W + simmitinib tablets, dose level 2, D1-D21, Q4W
    DP303c injection, dose level 1, intravenous drip, Q2W + simmitinib tablets, dose level 2, oral, QD, taken for 3 weeks, discontinued for 1 week, Q4W
  • Experimental: DP303c injection, dose level 2, Q3W + simmitinib tablets, dose level 2, D1-D21, Q4W
    DP303c injection, dose level 2, intravenous drip, Q3W + simmitinib tablets, dose level 2, oral, QD, taken for 3 weeks, discontinued for 1 week, Q4W
  • Experimental: DP303c RP2D + irinotecan liposomes RP2D
  • Active Comparator: Single agent chemotherapy chosen by researchers
    Single agent chemotherapy chosen by researchers: paclitaxel, docetaxel, or irinotecan

Primary Outcome Measure

Dose-limiting toxicity(DLT) occurrence and incidence [ Time Frame: Up to approximately 36 months after the first participant is enrolled ]