Phase 1
N=114
MSB0011359C (M7824) in Participants With Metastatic or Locally Advanced Solid Tumors
Solid Tumors
Bottom Line
View on ClinicalTrials.gov: NCT02699515 ↗Enrolled (actual)
114
Serious AEs
56.1%
Results posted
Nov 2024
Primary outcome: Primary: Number of Participants With Dose Limiting Toxicity (DLT) — 0; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MSB0011359C (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicity (DLT) |
0; 0; 1 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03 |
4; 3; 6; 28; 30; 30 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events (TRAEs) According to NCI-CTCAE Version 4.03 |
1; 2; 3; 19; 16; 19 | — |
| SECONDARY Dose-Escalation Phase: Maximum Serum Concentration (Cmax) of M7824 |
54.6; 211; 331 | — |
| SECONDARY Dose-Escalation Phase: Terminal Half Life (t1/2) of M7824 |
132; 138; 150 | — |
| SECONDARY Dose-Escalation Phase: Area Under the Serum Concentration Time Curve From Zero to Last Sampling Time (AUC0-t) of M7824 |
7940; 29200; 51300 | — |
| SECONDARY Dose-Escalation Phase: Area Under The Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of M7824 |
9600; 34600; 61700 | — |
| SECONDARY Dose-Escalation Phase: Number of Participants With Positive Serum Titers of Anti-Drug Antibodies of M7824 |
1; 0; 3 | — |
| SECONDARY Dose-Escalation Part: Number of Participants With Best Overall Response (BOR) As Assessed By Investigator |
0; 0; 0; 1; 0; 1 | — |
| SECONDARY Expansion Part: Best Overall Response (BOR) As Assessed By Investigator |
1; 2; 0; 6; 5; 6 | — |
| SECONDARY Expansion Part: BOR According to RECIST 1.1 As Adjudicated By The Independent Review Committee (IRC) |
2; 3; 0; 0; 0; 4 | — |
| SECONDARY Expansion Part: Duration of Response (DOR) |
NA; 20.8; 7.0 | — |
| SECONDARY Expansion Part: Disease Control Rate |
40.0; 22.6; 20; 1; 0 | — |
| SECONDARY Expansion Part: Progression Free Survival (PFS) Time |
2.5; 1.3; 1.4; 2.1; 1.2 | — |
| SECONDARY Expansion Part: Overall Survival (OS) Time |
12.7; 10.1; 11.9; 4.4; 4.0 | — |
Summary
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.
Eligibility Criteria
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 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)
Data sourced from ClinicalTrials.gov (NCT02699515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.