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drugset / Trial / NCT07056777

Evaluation of the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Cancer

NCT07056777 ↗

Phase 1/2 Recruiting 186 enrolled Zhejiang Doer Biologics Co., Ltd.
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-03-25
Primary completion
2027-04-30
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject DR30206 Unknown 15 mg/kg Intravenous
Subject DR30206 Unknown 20 mg/kg Intravenous
Subject DR30206 Unknown 30 mg/kg Intravenous
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Irinotecan Small molecule 180 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous
Background fluorouracil Small molecule 1200 mg/m2 Intravenous

Indications

digestive system cancer