Trials / Not Yet Recruiting
Not Yet RecruitingNCT06577376
A PhaseⅠ/Ⅱ Study of Simmitinib or Irinotecan Liposomes Combined With DP303c in Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
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
- Status
- Not Yet Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 252 (estimated)
- Sponsor
- Shanghai Runshi Pharmaceutical Technology Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-08-26
- Primary completion
- 2026-08-26
- Completion
- 2027-08-26
- First posted
- 2024-08-29
- Last updated
- 2024-09-05
Source: ClinicalTrials.gov record NCT06577376. Inclusion in this directory is not an endorsement.