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

Sponsor
Shenzhen Majory Biotechnology Co., Ltd.
Study ID
NCT07235202
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility Criteria

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

Interventions

Study Details

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.

Key Dates

Start date
Dec 24, 2025
Status verified
Dec 2025
Primary completion
Jun 22, 2028
Completion
Dec 22, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Part1, Dose Group 1: MR001+Irinotecan Liposome+LV/5-FU
    MR001, 2mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration
  • Experimental: Dose Escalation Part1, Dose Group 2: MR001+Irinotecan Liposome+LV/5-FU
    MR001, 4mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration
  • Experimental: Dose Escalation Part1, Dose Group 3: MR001+Irinotecan Liposome+LV/5-FU
    MR001, 6mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration
  • Experimental: Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine
    MR001, 2mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration
  • Experimental: Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine
    MR001, 4mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration
  • Experimental: Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine
    MR001, 6mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration
  • Experimental: Dose Expansion Part
    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

Primary Outcome Measure

Number of participants who experience one or more dose-limiting toxicities (DLTs) [ Time Frame: Approximately 12 months ]

Central Contacts

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