A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy
Not Applicable
Not yet recruiting
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Interventions
- Registration Number
- NCT07235202
- Lead Sponsor
- Shenzhen Majory Biotechnology Co., Ltd.
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 45
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation Part1, Dose Group 1: MR001+Irinotecan Liposome+LV/5-FU MR001 MR001, 2mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine Nab-paclitaxel MR001, 4mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine MR001 MR001, 6mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine Nab-paclitaxel MR001, 6mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine Gemcitabine (GEM) MR001, 6mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration Dose Escalation Part1, Dose Group 1: MR001+Irinotecan Liposome+LV/5-FU Irinotecan Liposome Injection combined with 5-FU/LV MR001, 2mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration Dose Escalation Part1, Dose Group 3: MR001+Irinotecan Liposome+LV/5-FU MR001 MR001, 6mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine MR001 MR001, 2mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine Gemcitabine (GEM) MR001, 2mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration Dose Expansion Part Nab-paclitaxel 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 Dose Expansion Part Gemcitabine (GEM) 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 Dose Escalation Part1, Dose Group 2: MR001+Irinotecan Liposome+LV/5-FU MR001 MR001, 4mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration Dose Escalation Part1, Dose Group 2: MR001+Irinotecan Liposome+LV/5-FU Irinotecan Liposome Injection combined with 5-FU/LV MR001, 4mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration Dose Escalation Part1, Dose Group 3: MR001+Irinotecan Liposome+LV/5-FU Irinotecan Liposome Injection combined with 5-FU/LV MR001, 6mg/kg, QW; Irinotecan Liposome+LV/5-FU, Per locally approved dosage and administration Dose Escalation Part2, Dose Group 1: MR001+nab-paclitaxel+gemcitabine Nab-paclitaxel MR001, 2mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine MR001 MR001, 4mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine Gemcitabine (GEM) MR001, 4mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration Dose Expansion Part MR001 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 Dose Expansion Part Irinotecan Liposome Injection combined with 5-FU/LV 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 Measures
Name Time Method Number of participants who experience one or more dose-limiting toxicities (DLTs) Approximately 12 months Maximum Tolerated Dose (MTD) of MR001 Approximately 12 months The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules
Objective Response Rate (ORR) Approximately 24 months Disease control rate (DCR) Approximately 24 months Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0 Approximately 30 months Best Overall Response (BOR) Approximately 24 months
- Secondary Outcome Measures
Name Time Method Recommended Phase II Dose (RP2D) of MR001 in combination with standard chemotherapy regimens in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) Approximately 12 months Progressionfree survival (PFS) Approximately 24 months Change from baseline at different time points for CD4 in plasma Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks) Overall survival (OS) Approximately 30 months Area Under the Plasma ConcentrationTime Curve (AUC) of MR001 Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks) Half-life (T1/2) of MR001 Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks) Change from baseline at different timepoints for Th2 in plasma Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks) Maximum Plasma Concentration (Cmax) of MR001 Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks) Incidence of Antidrug Antibodies (ADA) to MR001 Predose in every 4 cycles for approximately 18 months (each cycle = 2 weeks or 4 weeks) Change from baseline at different time points for Th1 in plasma Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks) Change from baseline at different timepoints for TGF-β1 in plasma Predose and at designated timepoints in each cycle for approximately 18 months (each cycle = 2 weeks or 4 weeks)
Trial Locations
- Locations (1)
Beijing Tsinghua Changgung Hospital
🇨🇳Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital🇨🇳Beijing, Beijing Municipality, ChinaJiahong Dong, MD, PhDContact+86-10-56118899dongjiahong@mail.tsinghua.edu.cn