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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Doer Biologics Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Voluntarily sign a written informed consent form.

Patients must be ≥ 18 and ≤75 years of age.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Expected survival period of at least 3 months.

Disqualifiers

Subjects with MSI-H or dMMR.

A history of severe allergic reactions to other monoclonal antibodies (mAb) or bispecific antibodies, or known allergies to any investigational drug or its components in this study.

Use of high-dose corticosteroids (>10 mg/day prednisone or equivalent doses of other corticosteroids) or other immunosuppressive drugs within 14 days prior to the first administration of the investigational drug.

Received the following treatments or medications within 28 days before starting the study treatment: a. Inoculate live attenuated vaccines, or expect to receive such vaccines during the study treatment period or within 5 months after the last administration of the study treatment; b.Systemic treatment with anti-tumor drugs, or local anti-tumor therapy.

Trial design

Treatments tested in this trial

  • DR30206
  • Oxaliplatin
  • Capecitabine
  • Calcium Folinate
  • 5-FU
  • Irinotecan (CPT-11)

Treatment groups

186 Participants
are divided into 3 treatment groups