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


About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mitesh Borad, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office


More information


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