A Clinical Study of MHB034C for Injection in Participants With Advanced Solid Tumors

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 1 / Phase 2

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

400 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This study is an open-label, multicenter, first-in-human (FIH) Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of MHB034C in participants with advanced solid tumors.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Participants voluntarily agree to participate in this study and sign the informed consent form.
2. Aged ≥ 18 years, regardless of sex.
3. ECOG Performance Status (PS) score of 0-1.
4. Life expectancy of more than 3 months.
5. Female participants of childbearing potential, and male participants whose partners are women of childbearing potential, must agree to use highly effective contraception with their partners; must refrain from donating gametes, from initiating gamete cryopreservation, and from retrieving or using their own previously cryopreserved gametes for conception. Female participants of childbearing potential must have a negative serum β-HCG pregnancy test within 7 days prior to the first use of the investigational medicinal product (IMP), and must not be lactating.
6. Ability to understand the study requirements and willingness and ability to comply with the study and follow-up procedures.
7. Participants enrolled in the Phase I dose escalation stage must have advanced solid tumors confirmed by histopathological or cytological examination, and must have progressed on or been intolerant to standard therapy, or have no standard treatment available.
8. Participants enrolled in the Phase II dose expansion stage must have advanced solid tumors confirmed by histopathological or cytological examination, and must have progressed on or been intolerant to standard therapy, or have no standard treatment available.
9. During the dose escalation stage, the investigator should make best efforts to obtain consent from participants to provide pre-treatment tumor tissue samples; during the dose expansion stage, participants must agree to provide pre-treatment tumor tissue samples, and if such samples cannot be provided, enrolment is permitted only with the sponsor's approval.
10. At least one measurable tumor lesion according to the RECIST v1.1 criteria.
11. Adequate bone marrow function.
12. Adequate hepatic function.
13. Adequate renal function.
14. Adequate coagulation function.
15. Adequate cardiac function.

Exclusion Criteria:

1. Has had another primary malignancy within 3 years prior to signing the informed consent form, excluding early-stage malignancies that have been curatively treated.
2. Has previously used or is currently using an antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as the payload, with certain exceptions.
3. Has previously received doxorubicin at a cumulative dose of \> 360 mg/m² or an equivalent dose of a similar agent.
4. Has received chemotherapy or endocrine therapy within 3 weeks, or radiotherapy, biological therapy, immunotherapy, or other anti-tumor therapy within 4 weeks, prior to the first dose of the investigational medicinal product .
5. Has spinal cord compression, leptomeningeal metastasis, brainstem metastasis, or unstable brain metastasis.
6. Adverse events from prior anti-tumor therapy have not resolved to ≤ Grade 1 as assessed by NCI-CTCAE v6.0.
7. Has undergone major surgery on a major organ (excluding biopsy) or experienced significant trauma within 4 weeks prior to the first use of the IMP, or requires elective surgery during the study period, or currently has severe unhealed or dehiscent wounds, active and clinically significant ulcers, untreated fractures, or active unhealed stomatitis.
8. Has received a live vaccine or live attenuated vaccine within 4 weeks prior to the first use of the IMP.
9. Has received or requires systemic corticosteroids or other immunosuppressive therapy within 14 days prior to the first use of the IMP, excluding topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroid therapy, and short-term corticosteroid use for prophylaxis.
10. Has moderate or severe pulmonary disease that significantly impairs pulmonary function.
11. Has a history of interstitial lung disease/pneumonitis (ILD), currently has ILD, or suspected ILD that cannot be ruled out by imaging during screening.
12. Has severe cardiovascular disease or high-risk factors.
13. Has experienced an arterial/venous thrombotic event within 6 months prior to the first dose.
14. Has a clinically evident or uncontrolled third-space fluid collection requiring repeated drainage.
15. Currently has an active autoimmune disease, or has a history of active autoimmune disease requiring systemic immunosuppressive therapy within 2 years prior to the first use of the IMP.
16. Has clinically significant corneal disease, or is currently using other medications that may cause corneal damage.
17. Has an active infection requiring systemic therapy within 7 days prior to the first dose.
18. Has clinically uncontrolled diabetes mellitus.
19. Has active tuberculosis, or a history of tuberculosis infection that was not controlled after treatment, or is still receiving anti-tuberculosis therapy; or has active syphilis.
20. Positive serological virology results: positive for HIV antibody; or positive for HBsAg or HBcAb with HBV-DNA ≥ 500 IU/mL; or positive for HCV antibody with positive HCV-RNA.
21. Has experienced clinically significant bleeding symptoms or an obvious bleeding tendency within 1 month prior to the first dose.
22. Has known hypersensitivity or delayed hypersensitivity to certain components or analogues of the IMP in this study.
23. Has a history of severe neurological or psychiatric disorders, or a history of psychotropic substance abuse or drug abuse, or any other medical condition.
24. Has known alcohol or drug dependence.
25. Has insufficient compliance to participate in this clinical study in the investigator's judgment, or the investigator considers that the participant has a history of other serious systemic diseases or other conditions unsuitable for participation in this study.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Minghui Pharmaceutical (Shanghai) LTD

Study start

Dec 20, 2026 Estimated

Primary completion

Jun 15, 2028 Estimated

Study completion

May 19, 2029 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts