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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Part1, Dose Group 1: MR001+Irinotecan Liposome+LV/5-FU | Experimental | MR001, 2mg/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 | Experimental | 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 | Experimental | 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 | Experimental | MR001, 2mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration |
|
| Dose Escalation Part2, Dose Group 2: MR001+nab-paclitaxel+gemcitabine | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR001 | Drug | Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experience one or more dose-limiting toxicities (DLTs) | Approximately 12 months | |
| Maximum Tolerated Dose (MTD) of MR001 | The maximum tolerated dose (MTD) of MR001 was assessed for QW dosing schedules | Approximately 12 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingshan Xue | Contact | +86 13332895357 | xueqs@majory.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgung Hospital | Recruiting | Beijing | Beijing Municipality | 102218 | China |
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MR001, 4mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration
|
| Dose Escalation Part2, Dose Group 3: MR001+nab-paclitaxel+gemcitabine | Experimental | MR001, 6mg/kg, QW; nab-paclitaxel+gemcitabine, Per locally approved dosage and administration |
|
| Dose Expansion Part | Experimental | 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 |
|
| 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 |
|
| 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) |
| 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 Th2 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) |
| 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) |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Active, not recruiting | Guangzhou | Guangdong | 510000 | China |
| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150081 | China |
|
| The First Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130015 | China |
|
| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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