Clinical trial · Interventional
A Study of MHB046C Injection in Patients With Advanced Solid Tumors
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB046C Injection in Patients With Advanced Solid Tumors
NCT06985355CI-TRIAL-00095376recruitingPhase 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 MHB046C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB046C 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 Solid Cancer | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MHB046C | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MHB046C (Phase I: Dose escalation)
- description
- There are six escalating dose cohorts.
- interventionNames
- Drug: MHB046C
- type
- EXPERIMENTAL
- label
- MHB046C (Phase II: Dose expansion)
- description
- The recommended dose from the dose-escalation stage and other potential doses will be further explored.
- interventionNames
- Drug: MHB046C
Primary outcomes (2)
- measure
- I (Dose-Escalation Stage): Maximum tolerated dose (MTD) for MHB046C
- timeFrame
- Up to day 21 from the first dose
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. Able to understand and comply with the study protocol and follow-up procedures. 6. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options. 7. At least one measurable lesion per RECIST v1.1 criteria. 8. Adequate 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 (2 weeks for palliative bone radiotherapy), or biologic, endocrine, or immunotherapy within 4 weeks before first study dose. 3. Brain metastases (unless asymptomatic, no edema, stable ≥4 weeks without steroids), leptomeningeal disease, brainstem metastases, or spinal cord compression. 4. Severe lung disease affecting pulmonary function. 5. Active systemic infection requiring treatment within 7 days before dosing. 6. Serious cardiovascular or cerebrovascular diseases 7. Uncontrolled third-space effusions not suitable for enrollment: 8. Uncontrolled diabetes, including ketoacidosis or hyperosmolar state within 6 months. 9. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose. 10. Known hypersensitivity or delayed allergic reaction to the investigational product or its components. 11. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results. 12. Known alcohol or drug dependence. 13. Pregnant or breastfeeding women, or individuals planning to conceive.
References
Publications (0)
Data not yet available
No reference posted for this study.