Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05828082
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-04-22
Brief Title:
Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of M1774 in Refractory SPOP-Mutant Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
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 II trial tests how well M1774 works in treating patients with prostate cancer that does not respond to treatment refractory and that has a mutation in the gene responsible for making the speckle type BTBPOZ protein SPOP M1774 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving M1774 may be able to shrink or stabilize refractory SPOP-mutant prostate cancer
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the response rate of tuvusertib ATR inhibitor M1774 in highly refractory prostate cancer
SECONDARY OBJECTIVES
I To evaluate the overall survival OS of refractory SPOP-mutant prostate cancer patients receiving tuvusertib M1774
II To evaluate the progression-free survival PFS of refractory SPOP-mutant prostate cancer patients receiving M1774
III To evaluate the Common Terminology Criteria for Adverse Events CTCAE 50-defined adverse event AE rates of refractory SPOP-mutant prostate cancer patients receiving M1774
EXPLORATORY OBJECTIVE
I To determine changes in SPOP-mutant circulating tumor deoxyribonucleic acid ctDNA and SPOP- ATR- and ATM-related gene signature changes on ATR inhibition including RAC1 FDFT1 DHCR24 DHCR7 and MVD
OUTLINE
Patients receive tuvusertib orally PO every day QD on days 1-14 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients also undergo biopsy magnetic resonance imaging MRI computed tomography CT positron emission tomography PETMRI PETCT or ultrasound US and collection of blood samples throughout the trial
After completion of study treatment patients are followed up every 6 months for 2 years
I To evaluate the response rate of tuvusertib ATR inhibitor M1774 in highly refractory prostate cancer
SECONDARY OBJECTIVES
I To evaluate the overall survival OS of refractory SPOP-mutant prostate cancer patients receiving tuvusertib M1774
II To evaluate the progression-free survival PFS of refractory SPOP-mutant prostate cancer patients receiving M1774
III To evaluate the Common Terminology Criteria for Adverse Events CTCAE 50-defined adverse event AE rates of refractory SPOP-mutant prostate cancer patients receiving M1774
EXPLORATORY OBJECTIVE
I To determine changes in SPOP-mutant circulating tumor deoxyribonucleic acid ctDNA and SPOP- ATR- and ATM-related gene signature changes on ATR inhibition including RAC1 FDFT1 DHCR24 DHCR7 and MVD
OUTLINE
Patients receive tuvusertib orally PO every day QD on days 1-14 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients also undergo biopsy magnetic resonance imaging MRI computed tomography CT positron emission tomography PETMRI PETCT or ultrasound US and collection of blood samples throughout the trial
After completion of study treatment patients are followed up every 6 months for 2 years
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UM1CA186709 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186709 |
| NCI-2023-03150 | REGISTRY | None | None |
| 10603 | OTHER | None | None |
| 10603 | OTHER | None | None |