Clinical trial · Interventional
A Study of MHB042C in Patients With Advanced Solid Tumors
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB042C for Injection in Patients With Advanced Solid Tumors
NCT07192107CI-TRIAL-00107793recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a first-in-human, open-label, multicenter Phase I/II study of MHB042C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB042C monotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Solid Tumor | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MHB042C for Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MHB042C (Phase I: Dose escalation)
- description
- There are seven escalating dose cohorts.
- interventionNames
- Drug: MHB042C for Injection
- type
- EXPERIMENTAL
- label
- MHB042C (Phase II: Dose expansion)
- description
- The recommended dose from the dose-escalation stage and other potential doses will be further explored.
- interventionNames
- Drug: MHB042C for Injection
Primary outcomes (2)
- measure
- (Dose-Escalation Stage): Dose-Limiting Toxicity (DLT) and Maximum tolerated dose (MTD) for MHB042C
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. -
References
Publications (0)
Data not yet available
No reference posted for this study.