At a glance
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A Phase Ib/IIa Clinical Trial Evaluating the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Tumors
In Brief
A Phase 1 clinical trial evaluating DR30206, Oxaliplatin, and 4 other interventions for Gastrointestinal Cancer. Currently recruiting, targeting 186 participants across 1 site.
Detailed 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.
Study Details
Timeline
Arms & Interventions
DR30206 20mpk Q3W or DR30206 30mpk Q3W; Oxaliplatin 130 mg/m2, d1, Q3W; Capecitabine 1000 mg/m2, bid, d1-14, Q3W;
DR30206 15mpk Q2W or DR30206 20mpk Q2W; Oxaliplatin 85 mg/m2, d1, Q2W; Calcium Folinate 400mg/m2, d1, Q2W; 5-FU 400mg/m2, d1 and 5-FU 1200mg/m2, d2-3, Q2W.
DR30206 15mpk Q2W or DR30206 20mpk Q2W; Irinotecan 180 mg/m2, d1, Q2W; Calcium Folinate 400mg/m2, d1, Q2W; 5-FU 400mg/m2, d1 and 5-FU 1200mg/m2, d2-3, Q2W.
Interventions
Subjects receive DR30206 intravenously
Subjects receive Oxaliplatin intravenously
Subjects take Capecitabine orally
Subjects receive Calcium Folinate intravenously
Subjects receive 5-FU by Intravenous Bolus
Subjects receive Irinotecan intravenously