Status:
NOT_YET_RECRUITING
A PhaseⅠ/Ⅱ Study of Simmitinib or Irinotecan Liposomes Combined With DP303c in Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
Lead Sponsor:
Shanghai Runshi Pharmaceutical Technology Co., Ltd
Conditions:
Localized Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
Expressing Human Epidermal Growth Factor Receptor-2 (HER-2)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 D...
Eligibility Criteria
Inclusion
- 1\. Aged 18-75 (including) years old; 2. Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology; 3. Disease progression after receiving one or two lines of systemic treatment in the past (first-line treatment must be platinum/fluorouracil combination chemotherapy with or without immune checkpoint inhibitors); 4. There should be at least one measurable lesion according to the response evaluation criteria in solid tumors (RECIST v1.1),; 5. HER2 expression status: 2+ to 3+(applicable to Cohort 1) or 1+(applicable to Cohort 2); 6. Adequate organ or bone marrow function
Exclusion
- \*Eligibility Criteria:
- Inclusion Criteria:
- Aged 18-75 (including) years old;
- Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;
- Disease progression after receiving one or two lines of systemic treatment in the past (first-line treatment must be platinum/fluorouracil combination chemotherapy with or without immune checkpoint inhibitors);
- There should be at least one measurable lesion according to the response evaluation criteria in solid tumors (RECIST v1.1),;
- HER2 expression status: 2+ to 3+(applicable to Cohort 1) or 1+(applicable to Cohort 2);
- Adequate organ or bone marrow function
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 26 2027
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT06577376
Start Date
August 26 2024
End Date
August 26 2027
Last Update
September 5 2024
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