MSB0011359C (M7824) in Participants With Metastatic or Locally Advanced Solid Tumors

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 1

Conditions

Solid Tumors

Treatments

Drug: MSB0011359C

Study type

Interventional

Funder types

Industry

Identifiers

NCT02699515

200647-0008

Details and patient eligibility

About

The main purpose of this study was to assess the safety and tolerability of MSB0011359C. Study consists of dose-escalation part and an expansion part in participants with metastatic or locally advanced solid tumors, for which no standard effective therapy exists or a standard therapy had failed.

Enrollment

114 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Able and willing to give written informed consent and had signed the appropriate written informed consent form (ICF), prior to performance of any trial activities
Eligible male and female participants aged greater than or equal to (>=)20 years
Histologically or cytologically proven metastatic or locally advanced solid tumors, for which no effective standard therapy exists or standard therapy had failed
Eastern Cooperative Oncology Group performance status (ECOG) performance status of 0 to 1 at trial entry
Life expectancy >=12 weeks as judged by the Investigator.
Adequate hematological function defined by white blood cell (WBC) count >=3*10^9/Liter with absolute neutrophil count (ANC) >=1.5*10^9/Liter, lymphocyte count >=0.5* 10^9/Liter, platelet count >=75*10^9/Liter, and Hemoglobin (Hgb) >= 9 grams per deciliter (g/dL) (in absence of blood transfusion)
Adequate hepatic function defined by a total bilirubin level <=1.5 × Upper limit of normal (ULN), an AST level <= 2.5 × ULN, and an ALT level <= 2.5 × ULN
Adequate renal function defined by an estimated creatinine clearance >50 milliliter per minute (mL/min) according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24 hour urine collection

Other protocol-defined exclusion 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, or 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; 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 with the exception of cervical carcinoma in situ and superficial or non invasive bladder cancer (treated with curative intent) within the last 5 years or 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 Central nervous system (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)