MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors

This is a Phase I, open-label, dose-escalation trial with consecutive parallel-group
expansion in selected solid tumor indications. The current trial is composed of a standard
dose escalation "3 + 3" cohort design, for which 3 to 6 subjects will be enrolled at each
dose level depending on the occurrence of dose limiting toxicities (DLTs), followed by a
consecutive parallel-group expansion in selected solid tumor indications. Cohorts of 3
subjects with metastatic or locally advanced solid tumors, for which no standard effective
therapy exists or standard therapy has failed, will receive MSB0011359C (M7824) at escalating
dose levels. After determination of the Maximum tolerated dose (MTD), enrollment in several
expansion cohorts will be opened to determine the safety, pharmacokinetic (PK) /
Pharmacodynamic, and clinical activity of MSB0011359C (M7824). Subjects who have experienced
a confirmed complete response (CR) should continue treatment through the end of 12 months,
although additional treatment is possible. In the case of progressive disease (PD), subjects
should continue treatment through their next tumor assessment. Additional indications will be
planned based on emerging data in the field.

Inclusion Criteria:

- Ability to understand the purpose of the study, provide signed and dated informed
consent, and able to comply with all procedures

- Male or female subjects aged greater than or equal to (>=) 18 years

- Life expectancy >= 12 weeks as judged by the Investigator

- 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 male and female subjects if the risk of conception
exists

Other protocol-defined inclusion 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 radiotherapy
delivered in a normal organ-spearing technique), immune therapy, or cytokine therapy

- Major surgery within 28 days before the start of trial treatment (prior diagnostic
biopsy is permitted)

- Systemic therapy with immunosuppressive agents within 7 days before the start of trial
treatment; or 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) within the last 3 years. Subjects with history of cervical carcinoma in
situ, superficial or non invasive bladder cancer or basal cell or squamous cell cancer
in situ previously treated with curative intent are NOT excluded. Subjects with other
localized malignancies treated with curative intent need to be discussed with the
Medical Monitor.

- Rapidly progressive disease which, in the opinion of the Investigator, may predispose
to inability to tolerate treatment or trial procedures

- Subjects with active central nervous system (CNS) metastases causing clinical symptoms
or metastases that require therapeutic intervention are excluded

- 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 exclusion criteria could apply