Ignite Creation Date:
2024-05-06 @ 5:40 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05396833
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2022-05-24
Brief Title:
Study of Tuvusertib M1774 in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor DDRiver Solid Tumors 320
Sponsor:
EMD Serono Research Development Institute Inc
Organization:
EMD Serono
Study Overview
Official Title:
An Open-label Multicenter Phase Ib Study of the Safety Tolerability and PharmacokineticPharmacodynamic Profile of the ATR Inhibitor Tuvusertib M1774 in Combination With DNA Damage Response Inhibitors or Immune Checkpoint Inhibitors in Patients With Metastatic or Locally Advanced Unresectable Solid Tumors DDRiver Solid Tumors 320
Status:
RECRUITING
Status Verified Date:
2024-10
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 is an open-label multicenter clinical study conducted in multiple parts to establish the safety tolerability PharmacokineticPharmacodynamic PKPD profile maximum tolerated dose MTD combinations if observed and recommended dose for expansion RDE combination for tuvusertib in combination with lartesertib in Part A1 food effect on the PK of lartesertib as monotherapy followed by treatment with tuvusertib in combination with lartesertib in participants with specific tumor types in Part A11 relative bioavailability of a tuvusertib tablet formulation vs capsule formulation followed by treatment with tuvusertib capsule in combination with lartesertib in participants with specific tumor types in Part A12 safetytolerability and early signs of clinical activity of tuvusertib capsuleand lartesertib in combination in participants with prostate cancer harboring loss of function LoS mutation in the gene ATM based on historic data collected prior to prescreening in circulating tumor ct DNA liquid biopsies or tumor biopsies in Part A2 safetytolerability and early signs of clinical activity of tuvusertib and lartesertib in combination in participants with endometrial cancer harboring LoS mutations in the gene ARID1A based on historic data collected prior to prescreening in ctDNA liquid biopsies or tumor biopsies in Part A3 the relative bioavailability of a tuvusertib tablet formulation TF1 test compared to a capsule formulation reference will also be investigated in Part A2A3 and identify a potential set of MTD combinations and establish the RDE for the combination of tuvusertib and avelumab in participants with metastatic or locally advanced unresectable solid tumors in Part B1
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-500287-35-00 | OTHER | EU Trial Number | None |