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Study of MHB088C in Participants With Advanced or Metastatic Solid Tumors

Advanced or Metastatic Solid Tumors Clinical Trial

Official title:
Phase 1/2, Two-Part, Multi-center, Open-label, Dose Escalation and Dose Expansion First-In-Human Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Efficacy of MHB088C in Participants With Advanced or Metastatic Solid Tumors

Clinical Trial Summary

This study will evaluate the safety/tolerability, pharmacokinetics and efficacy of MHB088C in participants with advanced or metastatic solid tumors.

Clinical Trial Description

This study is the first-in-human (FIH) trial of MHB088C, which contains two parts: dose escalation (part one) and dose expansion (part two). Part one: Dose Escalation Study of MHB088C Monotherapy in Participants with Advanced or Metastatic Malignant Solid Tumors The dose escalation part is an open-label, multi-center study in which the eligible participants with advanced or metastatic solid tumors will be enrolled to receive MHB088C monotherapy to assess the safety and tolerability of MHB088C in participants with advanced or metastatic solid tumors, to determine the maximum tolerated dose (MTD) of MHB088C, 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 MHB088C monotherapy. Participants with same types of solid tumors will be randomised 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 MHB088C monotherapy in participants 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 MHB088C. ;

Study Design

Related Conditions & MeSH terms

  • Advanced or Metastatic Solid Tumors
  • Neoplasms
Clinical Trial Details
NCT number NCT05652855
Study type Interventional
Source Minghui Pharmaceutical Pty Ltd
Contact Contact for Clinical Trial Information Minghui Pharmaceutical
Phone 086-02160898367
Email minghui_ra@minghuipharma.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date January 23, 2023
Completion date July 31, 2026
View Details
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