Advanced Lung CancerPhase 1/2NCT07229599
A Study of MHB036C Combined With Anti-tumor Therapies in Patients With Advanced Lung Cancer
A Phase 1/2 study testing MHB036C for Injection, MHB039A for Injection and Furmonertinib in people with Advanced Lung Cancer, run by Minghui Pharmaceutical (Hangzhou) Ltd at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Lung Cancer
- What is being tested?
- MHB036C for Injection, MHB039A for Injection and Furmonertinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2025to May 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- -
Who cannot join
- 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.
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- 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.
- Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
- Known alcohol or drug dependence.
- Pregnant or breastfeeding women, or individuals planning to conceive. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Ethics Committee, +86 021-22200000-5341, chestgcp@126.com
About this study
Official title: A Phase I/II Clinical Study to Evaluate the Efficacy and Safety of MHB036C for Injection Combined With Other Anti-tumor Therapy in Patients With Advanced Lung Cancer
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.
Read the detailed description
This first-in-human clinical trial of MHB036C combined with MHB039A or other anti-tumor therapy comprises two parts: a dose escalation phase and dose expansion phase. The dose escalation phase is an open-label, multicenter study including dose escalation and PK expansion cohorts. The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MHB036C combining different anti-tumor treatment regimens (including Furmonertinib, MHB039A for injection, and Carboplatin) in patients with advanced lung cancer, and to determine the maximum tolerated dose (MTD). Additional patients may be enrolled in the PK expansion part at dose levels that have completed DLT (dose-limiting toxicity) evaluation.
Based on the safety, PK, and preliminary efficacy data from the completed DLT-evaluated dose levels, the sponsor will initiate the dose expansion phase to further evaluate the safety and efficacy of MHB036C combined with MHB039A or other anti-tumor therapy in patients with specific types of advanced lung cancer.
- Conditions
- Advanced Lung Cancer
- Being tested
- MHB036C for Injection, MHB039A for Injection, Furmonertinib, Carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHB036C for InjectionDrug
IV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
MHB039A for InjectionDrug
IV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
FurmonertinibDrug
Oral administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
CarboplatinDrug
IV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation: cohort 1 | Experimental | Subjects will receive MHB036C Q3W by intravenous administration in combination with Furmonertinib QD by oral administration. Receives: Drug: MHB036C for Injection; Drug: Furmonertinib |
| Dose escalation: cohort 2 | Experimental | Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration Receives: 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 Receives: 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. Receives: Drug: MHB036C for Injection; Drug: Furmonertinib |
| Dose expansion: cohort 5 | Experimental | Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration Receives: 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 Receives: Drug: MHB036C for Injection; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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
Measured: 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].
Measured: 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).
Measured: 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
The PK parameters at different time points include: Area Under the Concentration-Time Curve (AUC)
Measured: From pre-dose to 22 days after the first dose
Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points
The PK parameters at different time points include: Maximum Plasma Concentration (Cmax)
Measured: From pre-dose to 22 days after the first dose
Duration of response (DOR) determined by investigators according to RECIST v1.1
DoR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used [Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].
Measured: 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
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) [Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose].
Measured: 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
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). PFS was defined as the time from random assignment (dose expansion stage) or first dose (dose escalation stage) to PD or death from any cause.
Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start9 May 2025
- Primary completionMay 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung CancerStudies of the same condition, open and under way.
- More trials run by Minghui Pharmaceutical (Hangzhou) LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minghui Pharmaceutical (Hangzhou) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229599
- Sponsor's protocol ID
- MHB036C-A-201
- Status last verified
- Oct 2025
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study to Evaluate the Efficacy and Safety of MHB036C for Injection Combined With Other Anti-tumor Therapy in Patients With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT07229599
- Acronym / sponsor ID
- MHB036C-A-201
- Conditions
- Advanced Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Minghui Pharmaceutical (Hangzhou) LtdIndustry (pharma, biotech, devices)
- Study start
- 9 May 2025 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This first-in-human clinical trial of MHB036C combined with MHB039A or other anti-tumor therapy comprises two parts: a dose escalation phase and dose expansion phase. The dose escalation phase is an open-label, multicenter study including dose escalation and PK expansion cohorts. The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MHB036C combining different anti-tumor treatment regimens (including Furmonertinib, MHB039A for injection, and Carboplatin) in patients with advanced lung cancer, and to determine the maximum tolerated dose (MTD). Additional patients may be enrolled in the PK expansion part at dose levels that have completed DLT (dose-limiting toxicity) evaluation.
Based on the safety, PK, and preliminary efficacy data from the completed DLT-evaluated dose levels, the sponsor will initiate the dose expansion phase to further evaluate the safety and efficacy of MHB036C combined with MHB039A or other anti-tumor therapy in patients with specific types of advanced lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose escalation: cohort 1 | Experimental | Drug: MHB036C for Injection, Drug: FurmonertinibSubjects will receive MHB036C Q3W by intravenous administration in combination with Furmonertinib QD by oral administration. |
| Dose escalation: cohort 2 | Experimental | Drug: MHB036C for Injection, Drug: MHB039A for InjectionSubjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration |
| Dose escalation: cohort 3 | Experimental | Drug: MHB036C for Injection, Drug: CarboplatinSubjects will receive MHB036C Q3W in combination with Carboplatin AUC 5mg/mL/min by intravenous administration |
| Dose expansion: cohort 4 | Experimental | Drug: MHB036C for Injection, Drug: FurmonertinibSubjects will receive MHB036C Q3W by intravenous administration in combination with Furmonertinib QD by oral administration. |
| Dose expansion: cohort 5 | Experimental | Drug: MHB036C for Injection, Drug: MHB039A for InjectionSubjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration |
| Dose expansion: cohort 6 | Experimental | Drug: MHB036C for Injection, Drug: CarboplatinSubjects will receive MHB036C Q3W in combination with Carboplatin AUC 5mg/mL/min by intravenous administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MHB036C for InjectionIV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression. | Drug | 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 InjectionIV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression. | Drug | Dose escalation: cohort 2, Dose expansion: cohort 5 |
| FurmonertinibOral administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression. | Drug | Dose escalation: cohort 1, Dose expansion: cohort 4 |
| CarboplatinIV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression. | Drug | Dose escalation: cohort 3, Dose expansion: cohort 6 |
Primary outcome
(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.
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)
Time frame: 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
Time frame: 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).
5 secondary outcomes
Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points
Time frame: From pre-dose to 22 days after the first dose
Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points
Time frame: From pre-dose to 22 days after the first dose
Duration of response (DOR) determined by investigators according to RECIST v1.1
Time frame: 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
Time frame: 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
Time frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MHB036C for Injection, MHB039A for Injection and Furmonertinib in people with Advanced Lung Cancer, run by Minghui Pharmaceutical (Hangzhou) Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CMO/ Senior Vice President of R&D (86 0571-86963293, jwshi@minghuipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.