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

ConditionPancreatic Ductal Adenocarcinoma (PDAC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen Majory Biotechnology Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MR001

    Drug

    Intravenous infusion

  • Irinotecan Liposome Injection combined with 5-FU/LV

    Drug

    Per locally approved formulation

  • Nab-paclitaxel

    Drug

    Per locally approved formulation

  • Gemcitabine (GEM)

    Drug

    Per locally approved formulation

Treatment groups

45 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Dose Escalation Part1, Dose Group 1: MR001+Irinotecan Liposome+LV/5-FUExperimental treatment 2 interventions
Group B: Dose Escalation Part1, Dose Group 2: MR001+Irinotecan Liposome+LV/5-FUExperimental treatment 2 interventions
Group C: Dose Escalation Part1, Dose Group 3: MR001+Irinotecan Liposome+LV/5-FUExperimental treatment 2 interventions
Group D: Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabineExperimental treatment 3 interventions
Group E: Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabineExperimental treatment 3 interventions
Group F: Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabineExperimental treatment 3 interventions
Group G: Dose Expansion PartExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Number of participants who experience one or more dose-limiting toxicities (DLTs)

Time frame
Approximately 12 months
2

Maximum Tolerated Dose (MTD) of MR001

The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules

Time frame
Approximately 12 months
3

Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0

Time frame
Approximately 30 months
4

Objective Response Rate (ORR)

Time frame
Approximately 24 months

Secondary outcomes

1

Recommended Phase II Dose (RP2D) of MR001 in combination with standard chemotherapy regimens in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)

Time frame
Approximately 12 months
2

Progressionfree survival (PFS)

Time frame
Approximately 24 months
3

Overall survival (OS)

Time frame
Approximately 30 months
4

Area Under the Plasma ConcentrationTime Curve (AUC) of MR001

Time frame
Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)

Other outcomes

Sponsors and contacts

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

Shenzhen Majory Biotechnology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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