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

Sponsor
Zhejiang Doer Biologics Co., Ltd.
Study ID
NCT07056777
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Gastrointestinal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • DR30206 — DRUG
    Subjects receive DR30206 intravenously
  • Oxaliplatin — DRUG
    Subjects receive Oxaliplatin intravenously
  • Capecitabine — DRUG
    Subjects take Capecitabine orally
  • Calcium Folinate — DRUG
    Subjects receive Calcium Folinate intravenously
  • 5-FU — DRUG
    Subjects receive 5-FU by Intravenous Bolus
  • Irinotecan (CPT-11) — DRUG
    Subjects receive Irinotecan intravenously

Study Details

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.

Key Dates

Start date
Mar 25, 2025
Status verified
Jan 2026
Primary completion
Apr 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
186 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DR30206+Oxaliplatin+Capecitabine
    DR30206 20mpk Q3W or DR30206 30mpk Q3W; Oxaliplatin 130 mg/m2, d1, Q3W; Capecitabine 1000 mg/m2, bid, d1-14, Q3W;
  • Experimental: DR30206+Oxaliplatin+Calcium Folinate+5-FU
    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.
  • Experimental: DR30206+Irinotecan+Calcium Folinate+5-FU
    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.

Primary Outcome Measure

Phase Ib: Incidence of dose limiting toxicities (DLTs) [ Time Frame: 21 days or 28 days following first dose according to the arms. ]

Central Contacts

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