A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy

Shenzhen Majory Biotechnology Co., Ltd.

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)

Treatments: Drug: MR001; Drug: Irinotecan Liposome Injection combined with 5-FU/LV; Drug: Gemcitabine (GEM); Drug: Nab-paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT07235202

MJR-MR001-02

Details and patient eligibility

About

This Phase Ib/IIa study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of MR001 Combined with Chemotherapy in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed after first-line therapy.

Full description

This is an open-label, dose-escalation and dose-expansion Phase Ib/IIa study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of MR001 in combination with standard chemotherapy regimens in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed after first-line therapy.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed locally advanced or metastatic PDAC, progressed after only one prior line of systemic therapy.
• At least one measurable lesion per RECIST v1.1.
• ECOG Performance Status of 0-1.
• Life expectancy >3 months.
• Adequate organ and marrow function as defined by laboratory parameters.
• Voluntarily sign the informed consent form.

Exclusion criteria

• Known hypersensitivity to MR001 or similar monoclonal antibodies.
• Requirement for systemic immunosuppressive therapy within 14 days before first dosing.
• Uncontrolled active infections or concurrent malignancies.
• Not adequately controlled active brain metastases or leptomeningeal metastasis.
• Clinically significant cardiovascular, renal, or hepatic disorders.
• Pregnant or breastfeeding women.
• Any other circumstances which the investigator considers may increase risks to subjects or interfere with the results of the trial.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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45 participants in 7 patient groups

Dose Escalation Part1, Dose Group 1: MR001+Irinotecan Liposome+LV/5-FU

Experimental group

Description:

MR001, 2mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration

Treatment:

Drug: Irinotecan Liposome Injection combined with 5-FU/LV

Drug: MR001

Dose Escalation Part1, Dose Group 2: MR001+Irinotecan Liposome+LV/5-FU

Experimental group

Description:

MR001, 4mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration

Treatment:

Drug: Irinotecan Liposome Injection combined with 5-FU/LV

Drug: MR001

Dose Escalation Part1, Dose Group 3: MR001+Irinotecan Liposome+LV/5-FU

Experimental group

Description:

MR001, 6mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration

Treatment:

Drug: Irinotecan Liposome Injection combined with 5-FU/LV

Drug: MR001

Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine

Experimental group

Description:

MR001, 2mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration

Treatment:

Drug: Nab-paclitaxel

Drug: Gemcitabine (GEM)

Drug: MR001

Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine

Experimental group

Description:

MR001, 4mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration

Treatment:

Drug: Nab-paclitaxel

Drug: Gemcitabine (GEM)

Drug: MR001

Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine

Experimental group

Description:

MR001, 6mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration

Treatment:

Drug: Nab-paclitaxel

Drug: Gemcitabine (GEM)

Drug: MR001

Dose Expansion Part

Experimental group

Description:

Based on the Dose escalation part results, the Investigator and Sponsor will determine one dose and dosing interval to proceed to the dose expansion study

Treatment:

Drug: Nab-paclitaxel

Drug: Gemcitabine (GEM)

Drug: Irinotecan Liposome Injection combined with 5-FU/LV

Drug: MR001