Clinical trial · Interventional
A Study of MHB039A for Advanced Solid Tumor
A Phase I/II Study of MHB039A for Advanced Solid Tumor to Evaluate the Efficacy and Safety
NCT06345482CI-TRIAL-00097619active not recruitingPhase 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)
Phase I/II open label, multicenter study to evaluate the efficacy and safety of MHB039A in advanced malignant tumors.
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 Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MHB039A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MHB039A
- description
- MHB039A IV every 2 weeks or every 3 weeks (including 5mg/kg、10mg/kg、20mg/kg and 30mg/kg)
- interventionNames
- Drug: MHB039A
Primary outcomes (2)
- measure
- Incidence of participants with adverse events (AE)
- timeFrame
- Until 30 days after last dose of MHB039A
- description
- An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
- measure
- Number of participants with dose-limiting toxicity (DLT)
- timeFrame
- At the end of Cycle 1 (each cycle is 21 days for every three weeks cohort and 28 days for every two weeks cohort)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy. * Written and signed informed consent * Aged 18 years or older * Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1 * Life expectancy \>=3 months Exclusion Criteria: * Prior malignancy active within the previous 5 years except for the tumor for which a subject is enrolled in the study, and locally curable cancers that have been apparently cured, (e.g. basal cell skin cancer, or carcinoma in situ of the cervix or others) * Receiving any chemotherapy within 3 weeks prior to the first dose；or other systemic anticancer therapy within 4 weeks prior to the first dose * Receiving prior anti-PD-1, anti-PD-L1, anti-CTLA(cytotoxic T-lymphocyte-associated protein)-4 or any other immunotherapy or immune-oncology (IO) agent within 28 days of first dose with MHB039A or experienced a toxicity that led to permanent discontinuation of prior immunotherapy * Unresolved toxicities from prior anticancer therapy
References
Publications (0)
Data not yet available
No reference posted for this study.