drugset / Trial / NCT02157792
M6620 First in Human Study
Phase 1
Completed
200 enrolled
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics (PK) of M6620 in Combination With Cytotoxic Chemotherapy in Participants With Advanced Solid Tumors
Timeline
- Start
- 2012-12-10
- Primary completion
- 2020-03-11
- Completion
- 2020-03-11
Publications
- Middleton MR, Dean E, Evans TRJ, Shapiro GI, Pollard J, Hendriks BS, Falk M, Diaz-Padilla I, Plummer R. Phase 1 study of the ATR inhibitor berzosertib (formerly M6620, VX-970) combined with gemcitabine +/- cisplatin in patients with advanced solid tumours. Br J Cancer. 2021 Aug;125(4):510-519. doi: 10.1038/s41416-021-01405-x. Epub 2021 May 26.
- Shapiro GI, Wesolowski R, Devoe C, Lord S, Pollard J, Hendriks BS, Falk M, Diaz-Padilla I, Plummer R, Yap TA. Phase 1 study of the ATR inhibitor berzosertib in combination with cisplatin in patients with advanced solid tumours. Br J Cancer. 2021 Aug;125(4):520-527. doi: 10.1038/s41416-021-01406-w. Epub 2021 May 26.
- Terranova N, Jansen M, Falk M, Hendriks BS. Population pharmacokinetics of ATR inhibitor berzosertib in phase I studies for different cancer types. Cancer Chemother Pharmacol. 2021 Feb;87(2):185-196. doi: 10.1007/s00280-020-04184-z. Epub 2020 Nov 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Berzosertib | Small molecule | 18 mg/m2 | Intravenous |
| Subject | Berzosertib | Small molecule | 140 mg/m2 | Intravenous |
| Subject | Berzosertib | Small molecule | 210 mg/m2 | Intravenous |
| Subject | Carboplatin | Small molecule | — | — |
| Subject | Cisplatin | Other / unclassified | 40 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 60 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Subject | Etoposide | Small molecule | — | — |
| Subject | Gemcitabine | Small molecule | 875 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Irinotecan | Small molecule | — | — |