Pancreatic Ductal Adenocarcinoma (PDAC)
Conditions
Keywords
MR001, PDAC, CD4, TGF-β1
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.
Interventions
DRUGMR001
Intravenous infusion
Per locally approved formulation
DRUGNab-paclitaxel
Per locally approved formulation
Per locally approved formulation
Sponsors
Shenzhen Majory Biotechnology Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Incidence of Adverse Events (AEs) as Assessed by CTCAE v5.0 | Approximately 30 months | — |
| Objective Response Rate (ORR) | Approximately 24 months | — |
| Best Overall Response (BOR) | Approximately 24 months | — |
| Disease control rate (DCR) | Approximately 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| 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 |
| 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) |
| 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) |
| 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) |
| Progressionfree survival (PFS) | Approximately 24 months |
| 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) |
| 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) |
| 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) |
Countries
China
Contacts
Primary ContactQingshan Xue
Outcome results
None listed