Phase 1/2a Study of MPB-1734 in Patients With Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04643418|
Recruitment Status : Not yet recruiting
First Posted : November 25, 2020
Last Update Posted : November 25, 2020
MegaPro Biomedical Co. Ltd.
Information provided by (Responsible Party):
MegaPro Biomedical Co. Ltd.
This is a first-in-human (FIH), multicenter, open-label, uncontrolled, Phase 1/2a study with dose escalation in patients with advanced solid tumors (Part 1) and cohorts of up to 15 patients per selected indication (Part 2). The solid tumor types in Part 2 will be decided by the sponsor prior to the start of Part 2, but not be solely based on the efficacy results in Part 1.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor, Unspecified, Adult||Drug: MPB-1734||Phase 1 Phase 2|
This study will occur in two parts, Dose-escalation (Part 1) and Cohort-expansion (Part 2). The main purpose of Part 1 is to determine the doses and dosing schedule of MPB-1734 that is safe and tolerable when given in subjects with certain types of advanced cancer. Part 2 of the study will begin when the Sponsor determines the safe and tolerable doses and dosing schedule from Part 1. The main purpose of Part 2 is to continue to assess the safety and tolerability of the MPB-1734 dose and dosing schedule determined by the Sponsor during Part 1. The preliminary efficacy of MPB-1734 will also be assessed in both Part 1 and Part 2.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2a Dose-ranging, Safety, Pharmacokinetics, and Preliminary Efficacy Study of MPB-1734 in Patients With Advanced Solid Tumors in Part 1 and With Selected Solid Tumors in Part 2|
|Estimated Study Start Date :||March 2021|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||August 2024|
Experimental: MPB-1734, single arm, dose escalation
intravenous, once per 3 weeks, starting at 10 mg/m˄2
Administered once daily in a 21-day cycle
Other Name: DMB025
Primary Outcome Measures :
- Evaluation the recommended Phase 2 dose(RP2D) or the maximum tolerated dose(MTD) [ Time Frame: Through the end of the first cycle (Days 1-21). ]Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle.
Secondary Outcome Measures :
- Incidence of Treatment-Emergence Adverse Events (Safety and Tolerability) [ Time Frame: Approximately 24 weeks ]Each adverse event will be coded using the Medical Dictionary for Regulatory Activities (version 20.0) classification system. The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
- Maximum observed plasma concentration (Cmax) [ Time Frame: Day 1 ]
- Area under the plasma concentration-time curve (AUC) [ Time Frame: Day 1 ]
- half-life (T1/2) [ Time Frame: Day 1 ]Evaluation of PK parameters
No Contacts or Locations Provided