Recruiting
Phase 1/2
A Study of MHB088C Combined With MHB039A in Patients With Advanced Malignant Solid Tumors
Condition(s) studied
Advanced Malignant Solid Tumor
Investigational drug(s) / intervention(s)
MHB088C for Injection: Intravenous administration
MHB039A for Injection: Intravenous administration
Study summary
This is a first-in-human, open-label, multicenter Phase I/II study of MHB088C combined with MHB039A in patients with advanced malignant solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB088C and MHB039A combination therapy.
Eligibility
Inclusion Criteria:
1. Voluntarily agrees to participate in the study and signs the informed consent form.
2. Age ≥ 18 years, no restriction on gender.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Estimated life expectancy ≥ 3 months.
5. 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.
6. 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.
7. At least one measurable lesion per RECIST v1.1 criteria.
8. Adequate bone marrow reserve and organ function.
9. 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.
Exclusion Criteria:
1. History of ≥2 primary malignancies within 5 years prior to informed consent.
2. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before dosing.
3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.
4. Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
5. 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.
6. Previous or concurrent gastrointestinal perforation, surgical procedures and wound healing complications, as well as bleeding events.
7. Received intravenous thrombolysis treatment within 2 weeks, except for preventive anticoagulation and antiplatelet therapy.
8. Vaccinated within 4 weeks before dosing.
9. Treated with systemic corticosteroids within 14 days before dosing.
10. Severe lung disease affecting pulmonary function.
11. Active systemic infection requiring treatment within 7 days before dosing.
12. Uncontrolled third-space effusion.
13. Serious cardiovascular or cerebrovascular diseases.
14. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
15. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
16. Known alcohol or drug dependence.
17. Pregnant or breastfeeding women, or individuals planning to conceive.
Primary outcome measure(s)
- (Dose-Escalation Stage): Dose-Limiting Toxicity (DLT) and Maximum tolerated dose (MTD) for MHB088C and MHB039A combination therapy — Up to day 21 from the first dose for Q3W administration, or up to day 28 from the first dose for Q2W administration.
To determine the MTD for further evaluation of IV administration of MHB088C and MHB039A combination therapy in subjects with advanced solid tumors.
- (Dose-Expansion Stage): Objective tumor response (ORR) 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
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).
Trial sites (1)
| Facility | City | Region | Status |
| Ethics Committee of Shanghai East Hospital |
Shanghai |
Shanghai Municipality |
Recruiting |
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