A Study of MHB036C Combined With Anti-tumor Therapies in Patients With Advanced Lung Cancer

Sponsor
Minghui Pharmaceutical (Hangzhou) Ltd
Study ID
NCT07229599
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • MHB036C for Injection — DRUG
    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 — DRUG
    IV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
  • Furmonertinib — DRUG
    Oral administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
  • Carboplatin — DRUG
    IV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Study Details

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.

Key Dates

First listed
Nov 17, 2025
Start date
May 9, 2025
Status verified
Oct 2025
Primary completion
May 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation: cohort 1
    Subjects will receive MHB036C Q3W by intravenous administration in combination with Furmonertinib QD by oral administration.
  • Experimental: Dose escalation: cohort 2
    Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration
  • Experimental: Dose escalation: cohort 3
    Subjects will receive MHB036C Q3W in combination with Carboplatin AUC 5mg/mL/min by intravenous administration
  • Experimental: Dose expansion: cohort 4
    Subjects will receive MHB036C Q3W by intravenous administration in combination with Furmonertinib QD by oral administration.
  • Experimental: Dose expansion: cohort 5
    Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration
  • Experimental: Dose expansion: cohort 6
    Subjects will receive MHB036C Q3W in combination with Carboplatin AUC 5mg/mL/min by intravenous administration

Primary Outcome Measure

(Dose-Escalation Stage): Maximum tolerated dose (MTD) for MHB036C and other anti-tumor treatment combination therapy [ Time Frame: Up to day 21 from the first dose for Q3W administration. ]

Central Contacts

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