Evaluation of the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Cancer
NCT07056777 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 186
Last updated 2026-01-13
Summary
This is a multicenter, open-label phase Ib/IIa clinical study conducted in China, aimed at evaluating the safety tolerance, efficacy, pharmacokinetic (PK) characteristics, and immunogenicity of DR30206 in combination with standard treatment regimens for advanced or metastatic gastrointestinal tumors.
Conditions
Interventions
- DRUG
-
DR30206
Subjects receive DR30206 intravenously
- DRUG
-
Subjects receive Oxaliplatin intravenously
- DRUG
-
Subjects take Capecitabine orally
- DRUG
-
Calcium Folinate
Subjects receive Calcium Folinate intravenously
- DRUG
-
Subjects receive 5-FU by Intravenous Bolus
- DRUG
-
Irinotecan (CPT-11)
Subjects receive Irinotecan intravenously
Sponsors & Collaborators
-
Zhejiang Doer Biologics Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Yanshan Huang CEO · Zhejiang Doer Biologics Co., Ltd.
-
Ruihua Xu · Sun Yat-sen University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-25
- Primary Completion
- 2026-04-30
- Completion
- 2026-06-30
Countries
- China
Study Locations
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