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

NCT07229599 | Recruiting Phase 1

• 1 other identifier: MHB036C-A-201
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Lung Cancer

Outcome Measures

Primary Outcomes (3)

• (Dose-Escalation Stage): Maximum tolerated dose (MTD) for MHB036C and other anti-tumor treatment combination therapy

  To determine the MTD for further evaluation of MHB036C and other anti-tumor treatment combination therapy

  Up to day 21 from the first dose for Q3W administration.

• (Dose-Escalation Stage): Incidence and severity of adverse events (AEs)

  AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0\].

  Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years.

• (Dose-Expansion Stage): Objective tumor response (ORR) determined by investigators according to RECIST v1.1

  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).

  Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years

Secondary Outcomes (5)

• Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points

  From pre-dose to 22 days after the first dose

• Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points

  From pre-dose to 22 days after the first dose

• Duration of response (DOR) 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

• Disease control rate (DCR) 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

• Progression-free survival (PFS) 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

Study Arms (6)

Dose escalation: cohort 1

EXPERIMENTAL

Subjects will receive MHB036C Q3W by intravenous administration in combination with Furmonertinib QD by oral administration.

Drug: MHB036C for Injection; Drug: Furmonertinib

Dose escalation: cohort 2

EXPERIMENTAL

Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration

Drug: MHB036C for Injection; Drug: MHB039A for Injection

Dose escalation: cohort 3

EXPERIMENTAL

Subjects will receive MHB036C Q3W in combination with Carboplatin AUC 5mg/mL/min by intravenous administration

Drug: MHB036C for Injection; Drug: Carboplatin

Dose expansion: cohort 4

EXPERIMENTAL

Subjects will receive MHB036C Q3W by intravenous administration in combination with Furmonertinib QD by oral administration.

Drug: MHB036C for Injection; Drug: Furmonertinib

Dose expansion: cohort 5

EXPERIMENTAL

Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration

Drug: MHB036C for Injection; Drug: MHB039A for Injection

Dose expansion: cohort 6

EXPERIMENTAL

Subjects will receive MHB036C Q3W in combination with Carboplatin AUC 5mg/mL/min by intravenous administration

Drug: MHB036C for Injection; Drug: Carboplatin

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.

Dose escalation: cohort 1; Dose escalation: cohort 2; Dose escalation: cohort 3; Dose expansion: cohort 4; Dose expansion: cohort 5; Dose expansion: cohort 6

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.

Dose escalation: cohort 2; Dose expansion: cohort 5

Furmonertinib DRUG

Oral administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Dose escalation: cohort 1; Dose expansion: cohort 4

Carboplatin DRUG

IV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Dose escalation: cohort 3; Dose expansion: cohort 6

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily agrees to participate in the study and signs the informed consent form.
• Age ≥ 18 years and≤75 years, no restriction on gender.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Estimated life expectancy ≥ 3 months.
• For the dose escalation stage: Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
• For the dose expansion stage: Histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors, not suitable for radical surgery and/or radical concurrent/sequential radiotherapy and chemotherapy.
• At least one measurable lesion per RECIST v1.1 criteria.
• Adequate bone marrow reserve and organ function.
• Eligible participants of childbearing potential (males and females) must agree to take highly reliable contraceptive measures with their partners during the study and within at least 12 weeks after the last dose.

You may not qualify if:

• Small cell lung cancer (SCLC) components in the histopathology.
• History of ≥2 primary malignancies within 5 years prior to informed consent.
• Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
• Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.
• Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
• Underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose of investigational drug or requiring elective surgery during the study.
• Previous or concurrent gastrointestinal perforation, surgical procedures and wound healing complications, as well as bleeding events.
• Received intravenous thrombolysis treatment within 2 weeks, except for preventive anticoagulation and antiplatelet therapy.
• Vaccinated within 4 weeks before dosing.
• Treated with systemic corticosteroids within 14 days before dosing.
• Severe impairment of pulmonary function; interstitial lung disease or a history of pneumonia requiring steroid treatment; previous left or right pneumonectomy.
• Active systemic infection requiring treatment within 7 days before dosing.
• Uncontrolled third-space effusion.
• Serious cardiovascular or cerebrovascular diseases.
• Known hypersensitivity or delayed allergic reaction to the investigational product or its components.

Sponsors & Collaborators

• Minghui Pharmaceutical (Hangzhou) Ltd: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

Injections; aflutinib; Carboplatin

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Coordination Complexes; Organic Chemicals

Central Study Contacts

CMO/ Senior Vice President of R&D

CONTACT

86 0571-86963293; jwshi@minghuipharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: May 9, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)