Ignite Creation Date:
2024-05-06 @ 6:05 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05546268
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2022-09-16
Brief Title:
Study of Oral MRT-2359 in Selected Cancer Patients
Sponsor:
Monte Rosa Therapeutics Inc
Organization:
Monte Rosa Therapeutics Inc
Study Overview
Official Title:
A Phase 12 Study of Oral MRT-2359 in Patients With MYC-Driven and Other Selected Solid Tumors Including Lung Cancer and Diffuse B-Cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 12 open-label multicenter study is conducted in patients with previously treated selected solid tumors including non-small cell lung cancer NSCLC small cell lung cancer SCLC high-grade neuroendocrine cancer of any primary site diffuse large B-cell lymphoma DLBCL and tumors with L-MYC or N-MYC amplification Patients receive escalating doses of a GSPT1 molecular glue degrader MRT-2359 to determine safety tolerability maximum tolerated dose MTD andor recommended Phase 2 dose RP2D of MRT-2359 Once the MTD andor RP2D is identified additional patients enroll to Phase 2 study which includes molecular biomarkers stratification or selection namely expression or amplification of L-MYC and N-MYC genes hormone receptor positive HR-positive human epidermal growth factor 2 HER2-negative breast cancer and prostate cancer
Detailed Description:
This Phase 12 open-label multicenter dose escalation and expansion study to assess the safety tolerability pharmacokinetic PK pharmacodynamic PD and preliminary clinical activity of MRT-2359 in patients with previously treated selected solid tumors including lung cancer NSCLC and SCLC high-grade neuroendocrine cancer of any primary site and DLBCL
The primary aim of Phase 1 part is safety tolerability MTD andor RP2D of MRT-2359
The primary aim of Phase 2 part is assessment of preliminary anti-tumor activity of MRT-2359
The primary aim of Phase 1 part is safety tolerability MTD andor RP2D of MRT-2359
The primary aim of Phase 2 part is assessment of preliminary anti-tumor activity of MRT-2359
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None