Clinical trial · Interventional
A Study of MHB118C Injection in Patients With Advanced Solid Tumors
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB118C Injection in Patients With Advanced Solid Tumors
NCT07045454CI-TRIAL-00091604recruitingPhase 1ClinicalTrials.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 study of MHB118C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB118C 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 |
|---|---|---|---|
| MHB118C for Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MHB118C for Injection
- description
- MHB118C for Injection Q3W
- interventionNames
- Drug: MHB118C for Injection
Primary outcomes (2)
- measure
- Dose-Limiting Toxicity (DLT) for MHB118C
- timeFrame
- Up to day 21 from the first dose
- description
- DLTs will be assessed during the dose-escalation phase and are defined as toxicities related to MHB118C
- measure
- Maximum tolerated dose (MTD) for MHB118C
- timeFrame
- Up to day 21 from the first dose
- description
- To determine the MTD for further evaluation of IV administration of MHB118C in subjects with advanced solid tumors.
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, 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. Known hypersensitivity or delayed allergic reaction to the investigational product or its components. 9. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results. 10. Known alcohol or drug dependence. 11. Pregnant or breastfeeding women, or individuals planning to conceive.
References
Publications (0)
Data not yet available
No reference posted for this study.