Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545942
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Study of MOMA-313 Given as Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 1 multi-center open-label dose escalation and dose optimization study is designed to assess the safety tolerability pharmacokinetics PK pharmacodynamics PDx and preliminary clinical activity of MOMA-313 administered orally as a single agent or combination therapy in patients with homologous recombinant deficient solid tumors
Detailed Description:
MOMA-313 is a novel therapeutic agent designed to target homologous recombination HR-deficient cancers by inhibiting DNA polymerase theta MOMA-313 is being developed as a single-agent and in combination with a poly adenosine diphosphate ribose polymerase PARP inhibitor in patients with HR-deficient advanced or metastatic solid tumors
This phase 1 first-in-human open-label study of MOMA-313 is primarily intended to evaluate the safety and tolerability of MOMA-313 when administered orally as a single agent Treatment Arm 1 or in combination with olaparib Treatment Arm 2 Each treatment arm of the study includes a dose-escalation phase followed by a dose-optimization phase In the dose-escalation phase of each treatment arm successive cohorts of patients will receive increasing oral doses of MOMA-313 as a single agent or in combination with olaparib to determine the presumptive optimal biologic doses OBD in this population The dose-optimization phase of each arm will enroll additional patients to support the confirmation of the OBD
The data from this study conducted in patients with HR-deficient advanced or metastatic solid tumors including safety tolerability PKPDx findings and antitumor activity will form the basis for subsequent clinical development of MOMA-313 as a single-agent and in combination with olaparib
This phase 1 first-in-human open-label study of MOMA-313 is primarily intended to evaluate the safety and tolerability of MOMA-313 when administered orally as a single agent Treatment Arm 1 or in combination with olaparib Treatment Arm 2 Each treatment arm of the study includes a dose-escalation phase followed by a dose-optimization phase In the dose-escalation phase of each treatment arm successive cohorts of patients will receive increasing oral doses of MOMA-313 as a single agent or in combination with olaparib to determine the presumptive optimal biologic doses OBD in this population The dose-optimization phase of each arm will enroll additional patients to support the confirmation of the OBD
The data from this study conducted in patients with HR-deficient advanced or metastatic solid tumors including safety tolerability PKPDx findings and antitumor activity will form the basis for subsequent clinical development of MOMA-313 as a single-agent and in combination with olaparib
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None