Trials / Recruiting

RecruitingNCT07056777

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

A Phase Ib/IIa Clinical Trial Evaluating the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Tumors

Status: Recruiting
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 186 (estimated)

Sponsor: Zhejiang Doer Biologics Co., Ltd. · Industry
Sex: All
Age: 18 Years – 75 Years
Healthy volunteers: Not accepted

Summary

Detailed description

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. The study consists of two phases: the dose escalation phase (phase Ib) and the dose expansion phase (phase IIa). Based on the tumor type and treatment approach of the participants, different cohorts are established within both the phases Ib and IIa.

Conditions

Gastrointestinal Cancer

Interventions

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

Timeline

Start date: 2025-03-25
Primary completion: 2026-04-30
Completion: 2026-06-30
First posted: 2025-07-09
Last updated: 2026-01-13

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07056777. Inclusion in this directory is not an endorsement.