MHB048C for Injection: IV administration of MHB048C Q2W or Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Study summary
This is a first-in-human, open-label, multicenter Phase I/II study of MHB048C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB048C monotherapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
6. At least one measurable lesion per RECIST v1.1 criteria or one bone.
7. Adequate bone marrow reserve and organ function. -
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 first study dose.
3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug.
4. Brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
5. Severe bone damage caused by bone metastasis of prostate cancer.
6. Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1.
7. Severe lung disease affecting pulmonary function.
8. Vaccinated within 4 weeks before dosing.
9. Active systemic infection requiring treatment within 7 days before dosing.
10. Serious cardiovascular or cerebrovascular diseases.
11. Uncontrolled third-space effusions not suitable for enrollment.
12. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.
13. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
14. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
15. Known alcohol or drug dependence.
16. 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 MHB048C — Up to day 21 from the first dose for Q3W administration. To determine the MTD for further evaluation of IV administration of MHB048C monotherapy 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 To determine the recommended Phase II dose (RP2D) of MHB048C for the treatment of selected patients with advanced solid tumors based on the safety and efficacy results from all enrolled subjects.
Trial sites (1)
Facility
City
Region
Status
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
Recruiting
More Minghui Pharmaceutical (Hangzhou) Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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