A Study of the Safety, Tolerability, Drug/Body Interactions, Biological and Clinical Activity of MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors

Overview

Información sobre este estudio

The purpose of this study is to assess the safety, tolerability, drug/body interactions, and the biological and clinical activities of MSB0011359C (M7824) at different dose levels given to patients who have metastatic or locally advanced solid tumors.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria

  • Ability to understand the purpose of the study, provide signed and dated informed consent, and able to comply with all procedures
  • Males or females 
  • Age ≥ 18 years
  • Life expectancy ≥ 12 weeks as judged by the Investigator
  • May be on bisphosphonate or denosumab provided it has not been initiated within 14 days of receiving the first administration of MSB0011359C
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry
  • Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Adequate hematological, hepatic and renal function as defined in the protocol
  • Effective contraception for both males and females if the risk of conception exists
  • Other protocol-defined criteria could apply

Exclusion Criteria

  • Concurrent treatment with non-permitted drugs and other interventions
  • Anticancer treatment within 28 days before the start of trial treatment, for example
    • Cyto reductive therapy
    • Radiotherapy (with the exception of palliative bone directed radiotherapy)
    • Immune therapy
    • Cytokine therapy
  • Major surgery within 28 days before the start of trial treatment (excluding prior diagnostic biopsy)
  • Systemic therapy with immunosuppressive agents within 7 days before the start of trial treatment 
  • Use of any investigational drug within 28 days before the start of trial treatment
  • Previous malignant disease other than the target malignancy to be investigated in this trial with the exception of
    • Cervical carcinoma in situ and superficial or non invasive bladder cancer (treated with curative intent) within the last 5 years 
    • Basal cell or squamous cell carcinoma in situ within the last 3 years
  • Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures
  • Active or history of central nervous system metastases, except as in the melanoma-specific CNS criteria listed above
  • Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (eg, corneal transplant, hair transplant)
  • Other protocol-defined criteria could apply

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Mitesh Borad, M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publicaciones

Publications are currently not available
.
CLS-20304530

Mayo Clinic Footer