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NCT06345482

A Study of MHB039A for Advanced Solid Tumor

Traducción pendiente · disponible pronto
Activo, No Reclutando Fase 1

Descripción

Phase I/II open label, multicenter study to evaluate the efficacy and safety of MHB039A in advanced malignant tumors.

Criterios de Elegibilidad

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

Información del Ensayo

NCT06345482
Activo, No Reclutando
Fase 1
196 participantes
Abr 2024
Abr 2028

Ubicaciones1

China (1)
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030