A Study of MHB036C Combined With Anti-tumor Therapies in Patients With Advanced Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
MHB036C for Injection: IV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
MHB039A for Injection: IV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Furmonertinib: Oral administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Carboplatin: IV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Study summary
This is a first-in-human, open-label, multicenter Phase I/II study of MHB036C combined with MHB039A or other anti-tumor therapy in patients with advanced lung cancer. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB036C combined with MHB039A or other anti-tumor therapies.
Eligibility
Primary outcome measure(s)
- (Dose-Escalation Stage): Maximum tolerated dose (MTD) for MHB036C and other anti-tumor treatment combination therapy — Up to day 21 from the first dose for Q3W administration.
To determine the MTD for further evaluation of MHB036C and other anti-tumor treatment combination therapy - (Dose-Escalation Stage): Incidence and severity of adverse events (AEs) — Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years.
AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0\]. - (Dose-Expansion Stage): Objective tumor response (ORR) determined by investigators according to RECIST v1.1 — Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of CR and PR (Confirmed CR/PR assessment require at least 1 repeat).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | Recruiting |
More Minghui Pharmaceutical (Hangzhou) Ltd trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07229599 on ClinicalTrials.gov ↗ ← All trials in China