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Recruiting Phase 1/2

A Study of MHB009C in Patients With Advanced Solid Tumors

NCT07326488 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2026-03-17
Last updated
2026-04-13

Condition(s) studied

Advanced Malignant Solid Tumor

Investigational drug(s) / intervention(s)

MHB009C for Injection

MHB009C for Injection: IV administration of MHB009C 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 MHB009C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB009C 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 MHB009C — Up to day 21 from the first dose.
    To determine the MTD for further evaluation of IV administration of MHB009C 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 MHB009C for the treatment of selected patients with advanced solid tumors based on the safety and efficacy results from all enrolled subjects.

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center, Shanghai Shanghai Shanghai Municipality Recruiting
Official registry record

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.

View NCT07326488 on ClinicalTrials.gov ↗ ← All trials in China