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An Open-label, Multicenter Trial of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M1774 in Participants with Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)

Open-label, Multicenter Trial of M1774 (DDRiver Solid Tumors 301)

Yamaki Masataka

Merck Biopharma Co., Ltd.

1-8-1 Shimomeguro, Meguro-ku, Tokyo

MBJ_clinicaltrial_information@merckgroup.com

Yamaki Masataka

Merck Biopharma Co., Ltd.

1-8-1 Shimomeguro, Meguro-ku, Tokyo

+81-3-6756-0800

MBJ_clinicaltrial_information@merckgroup.com

Not Recruiting

Sept. 15, 2022

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

-Locally advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator (i.e., participants who have exhausted all standard of care options according to International Guidelines), which may convey clinical benefit.
-Part A3 only: Participants whose tumor has at least 1 of the following molecular defects:
-Cohort 1: loss of function mutations in the gene for ARID1A
-Cohort 2: loss of function mutations in the genes for ATRX and/or DAXX
-Cohort 3: loss of function mutation in the gene for ATM.
-Part A4 only: participants who are resident in Japan and self-report Japanese ethnicity
-Part A3 only: measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
-Adequate hematologic function
-Adequate hepatic function
-Adequate renal function
-Other protocol defined inclusion criteria could apply

- Presence of toxicities due to prior anticancer therapies (e.g., radiotherapy, chemotherapy, immunotherapies, etc.) that do not recover to <= Grade 1 with the exception of toxicities that do not pose a safety risk to the participant in the judgment of the Investigator (e.g., ongoing Grade 2 alopecia).
- Unstable angina, myocardial infarction, congestive heart failure >= II or a coronary revascularization procedure within 180 days of study entry. Calculated QTc average (using the Fridericia correction calculation) of > 450 msec for males and > 470 msec for females, that does not resolve with correction of electrolyte abnormalities.
- Any other clinical condition or uncontrolled concurrent illness which in the Investigator's opinion would not make the participant a good candidate for the clinical study
- Concurrent treatment with a nonpermitted drug/intervention
- Other protocol defined exclusion criteria could apply.

Both

Metastatic or Locally Advanced Unresectable Solid Tumors

[Part A4]M1774 will be administered at a dose and schedule determined as recommended dose for expansion (RDE) in Part A1.
[Part A3]M1774 will be administered at a dose and schedule determined as recommended dose for expansion (RDE) in Part A1.

[Part A4]
- Occurrence of DLTs during the DLT observation period.
- Occurrence of TEAEs and treatment-related AEs and deaths.
- Occurrence of abnormalities (Grade >= 3) in laboratory test values.
- Occurrence of markedly abnormal vital sign measurements.
- Occurrence of clinically significant abnormal ECGs.
- In addition to the safety profile, PK data will be used for identifying the local RDE in Japanese participants.
[Part A3]
- Occurrence of TEAEs and treatment-related AEs.
- Occurrence of abnormalities (Grade >= 3) in laboratory test values.
- Occurrence of markedly abnormal vital sign measurements.
- Occurrence of clinically significant abnormal ECGs.
- Objective response (confirmed CR or PR) by RECIST Version 1.1.

+81-3-3542-2511

Aug. 29, 2022

No

United States/United Kingdom/Spain/China