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

NCT06577376 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2024-09-05

No results posted yet for this study

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.

Conditions

  • Localized Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
  • Expressing 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.

Sponsors & Collaborators

  • Shanghai Runshi Pharmaceutical Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06577376 on ClinicalTrials.gov