NCT04643418

Phase 1/2a Study of MPB-1734 in Patients With Advanced Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: MegaPro Biomedical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Solid Tumor, Unspecified, Adult

Interventions

Type	Name	Description
DRUG	MPB-1734	Administered once daily in a 21-day cycle

Timeline

• Start date: 2022-03-08
• Primary completion: 2025-03-31
• Completion: 2025-12-01
• First posted: 2020-11-25
• Last updated: 2025-11-03

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study