2024-08-13
2027-05-31
2027-11-30
158
NCT06545942
MOMA Therapeutics
MOMA Therapeutics
INTERVENTIONAL
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
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.
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 dose(s) (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, PK/PDx findings, and antitumor activity, will form the basis for subsequent clinical development of MOMA-313 as a single-agent and in combination with olaparib.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-07-26 | N/A | 2025-02-28 |
2024-08-05 | N/A | 2025-03-03 |
2024-08-09 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: MOMA-313 Monotherapy (Treatment Arm 1) MOMA-313 administered as a single-agent in 21-day cycles. | DRUG: MOMA-313
|
| EXPERIMENTAL: MOMA-313 in Combination with Olaparib (Treatment Arm 2) MOMA-313 administered together with twice daily (BID) olaparib in 28-day cycles. | DRUG: MOMA-313
DRUG: Olaparib
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuation | To assess the safety and tolerability of MOMA-313 given as a single-agent or in combination with olaparib | From screening until treatment discontinuation (up to 35 months) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Identify the recommended phase 2 dose (RP2D) | Determine the RP2D of MOMA-313 as a single-agent or in combination with olaparib | From screening until treatment discontinuation (up to 35 months) |
| PK parameter: area under curve (AUC) of MOMA-313 | Up to 6 weeks with sparse sampling up to 35 months | |
| PK parameter: maximum concentration (Cmax) of MOMA-313 | Up to 6 weeks with sparse sampling up to 35 months | |
| PK parameter: time to maximum concentration of MOMA-313 | Up to 6 weeks with sparse sampling up to 35 months | |
| PK parameter: half-life of MOMA-313 | Up to 6 weeks with sparse sampling up to 35 months | |
| Plasma concentration of olaparib | Up to 6 weeks with sparse sampling up to 35 months | |
| Objective response rate (ORR) | ORR is defined as the percentage of subjects with evidence of a complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and/or Prostate Cancer Working Group-3 (PCWG-3). | Up to 35 months |
| Duration of response (DOR) | DOR is defined as time from first documented PR or better to disease progression (as assessed by RECIST v1.1 and/or PCWG-3 by Investigator assessment) or death whichever is earlier for participants who have achieved a CR or PR | Up to 35 months |
| Time to response (TTR) | TTR is defined as the period of time from the date of first dose of study treatment until the first objective documentation of a CR or PR per RECIST 1.1 and/or PCWG-3. | Up to 35 months |
| Progression free survival (PFS) | PFS is time from first dose of study treatment to progressive disease or death from any cause, whichever is earlier, as assessed via RECIST v1.1 and/or PCWG-3 by Investigator assessment | Up to 35 months |
| Disease control rate (DCR) | DCR defined by the proportion of subjects who achieved either a complete response (CR), partial response (PR), or stable disease (SD) at their first scheduled disease assessment according to disease-specific response criteria. | Up to 35 months |
| Overall survival (OS) | OS is defined as the time from first dose of study treatment to the date of death, irrespective of the cause of death | Up to 35 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: MOMA Clinical Trials Phone Number: (857) 285-3677 Email: clinicaltrials@momatx.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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