NCT05642949

Study of MHB036C in Participants With Advanced or Metastatic Solid Tumors

Phase 1/2, Multi-center, Open-label, Dose Escalation and Cohort Expansion Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Efficacy of MHB036C in Participants With Advanced or Metastatic Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Minghui Pharmaceutical Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, pharmacokinetics, and anti-tumor efficacy of MHB036C in participants with advanced or metastatic solid tumors.

Detailed description

This study is the first-in-human (FIH) trial of MHB036C, and contains two parts: dose escalation phase (part one) and dose expansion phase (part two). The dose escalation phase is an open-label, multi-center study in which eligible participants with advanced or metastatic solid tumors will be enrolled to receive MHB036C monotherapy. This study is designed to assess the safety and tolerability of MHB036C in participants with advanced or metastatic solid tumors, to determine the maximum tolerated dose (MTD) of MHB036C, and to assess its pharmacokinetic profile and preliminary efficacy. The dose expansion part is an open-label, multi-center, multi-cohort expansion study in which participants with advanced or metastatic solid tumors of some predefined cancer types will be enrolled to receive MHB036C monotherapy. Participants with same types of solid tumors will be randomized assigned into different selected dose groups, and will be treated with the corresponding dose. This study is designed to assess the preliminary efficacy and safety of MHB036C monotherapy in subjects with some types of advanced or metastatic solid tumors, so as to determine the recommended phase 2 dose (RP2D); and to assess the immunogenicity and pharmacokinetic profiles of MHB036C.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	MHB036C	MHB036C will be administered intravenously at a frequency of once every 3 weeks (Q3W).

Timeline

• Start date: 2023-01-23
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2022-12-08
• Last updated: 2023-01-09

Locations

3 sites across 1 country: Australia