NCT04689308

This is a Phase 1 Study of MH048 in Patients With Selected Relapsed/Refractory B-cell Malignancies

A Phase 1, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Antitumor Activity of MH048 in Subjects With Selected Relapsed/Refractory B-cell Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Minghui Pharmaceutical (Shanghai) LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 study of MH048 in patients with selected Relapsed/Refractory B-cell Malignancies.

Detailed description

This is an open-label, multi-center Phase 1 study of MH048 in patients with selected Relapsed/Refractory B-cell Malignancies. This study includes 2 parts: Part A is the dose escalation part of the study, and Part B is the dose expansion part of the study. In Part A, patients were enrolled using accelerated titration design for the first three single patient cohorts and 3+3 dose escalation design for the rest cohorts. The starting dose of MH048 in soft gel capsule form was 5 mg/day QD. Cycle length will be 28 days. In Part B, the dose and lymphoma subtypes for expansion phase will depend on the results from Part A.

Conditions

• Relapsed/Refractory B-cell Malignancies

Interventions

Type	Name	Description
DRUG	MH048	Soft gel capsules 5 mg and 25 mg，oral MH048 should be administered after an overnight fast.

Timeline

• Start date: 2021-01-07
• Primary completion: 2023-06-30
• Completion: 2023-10-01
• First posted: 2020-12-30
• Last updated: 2021-09-08

Locations

1 site across 1 country: China