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

ConditionGastrointestinal 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

186 Participants
are divided into 3 treatment groups
Group A: DR30206+Oxaliplatin+CapecitabineExperimental treatment 3 interventions
Group B: DR30206+Oxaliplatin+Calcium Folinate+5-FUExperimental treatment 4 interventions
Group C: DR30206+Irinotecan+Calcium Folinate+5-FUExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Phase Ib: Incidence of dose limiting toxicities (DLTs)

Dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.

Time frame
21 days or 28 days following first dose according to the arms.
2

Phase Ib: Incidence and severity of treatment-emergent adverse events (TEAEs)

The incidence and severity of AEs graded according to NCI-CTCAE v5.0.

Time frame
From the first dose up to 90 days after the last dose or initiation of new anti-tumor treatment
3

Phase Ib: Maximum tolerated dose(MTD)

As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort.

Time frame
21 days or 28 days following first dose according to the arms.
4

Phase Ib: Recommended phase 2 dose (RP2D)

A recommended phase 2 dose will be determined based on safety data.

Time frame
21 days or 28 days following first dose according to the arms.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Doer Biologics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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