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

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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