Clinical Trials in China / NCT06345482
Active, not recruiting
Phase 1/2
A Study of MHB039A for Advanced Solid Tumor
NCT06345482 · tracked via the Priya Life Science China tracker
Condition(s) studied
Advanced Solid Tumor
Study summary
Phase I/II open label, multicenter study to evaluate the efficacy and safety of MHB039A in advanced malignant tumors.
Eligibility
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
Primary outcome measure(s)
- Incidence of participants with adverse events (AE) — Until 30 days after last dose of MHB039A
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. - Number of participants with dose-limiting toxicity (DLT) — At the end of Cycle 1 (each cycle is 21 days for every three weeks cohort and 28 days for every two weeks cohort)
DLTs will be assessed during the dose-escalation phase and are defined as toxicities related to MHB039A which meet pre-defined severity criteria and occurs within the first cycle of treatment.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality |
More Minghui Pharmaceutical (Hangzhou) Ltd trials in China
A Study of MHB036C for Advanced Solid Tumor
Active, not recruiting
Other trials for the same condition
A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients.
Recruiting
A Study of LM-108 as Monotherapy or in Combination With Antitumor Therapies in Subjects With Advanced Solid Tumors
Active, not recruiting
A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors
Active, not 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 NCT06345482 on ClinicalTrials.gov ↗ ← All trials in China