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Advanced Solid TumorPhase 1NCT06545942

Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors

A Phase 1 study testing MOMA-313 and Olaparib in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by MOMA Therapeutics at 18 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MOMA-313 and Olaparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
18 sitesin 3 countries
Study dates
13 Aug 2024to 30 Nov 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Have histologically confirmed disease for each treatment arm as follows:
  • Treatment Arm 1 (MOMA-313 Monotherapy)
  • Advanced (including locally), relapsed or metastatic solid tumors that are not eligible for curative therapy, with any HR-deficient alteration.
  • Treatment Arm 2 (MOMA-313 in Combination with Olaparib):
  • Dose escalation: Advanced (including locally), relapsed or metastatic solid tumors that are not eligible for curative therapy, for which a PARP inhibitor is indicated, with select HR-deficient mutations. Patients may be PARP inhibitor naive or exposed.
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  • Dose optimization: Advanced (including locally), relapsed or metastatic CRPC or pancreatic ductal adenocarcinoma (PDAC) with select HR-deficient mutations. Patients must be PARP inhibitor naive.
  • Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and/or PCWG-3
  • ECOG PS ≤ 2
  • Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and/or surgery **hormonal therapy allowed. Palliative radiotherapy allowed.
  • Adequate organ function per local labs
  • Comply with contraception requirements
  • Written informed consent must be obtained according to local guidelines

Who cannot join

  • Active prior or concurrent malignancy (some exceptions allowed)
  • Clinically relevant cardiovascular disease
  • Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)
  • Known active infection
  • Prior polymerase theta inhibitor exposure
  • Known allergy, hypersensitivity, and/or intolerance to MOMA-313
Show all 15Show fewer
  • Olaparib exposed patients with known hypersensitivity to PARP inhibitors (for patients considered for olaparib only)
  • Impaired GI function that may impact absorption.
  • Patient is pregnant or breastfeeding.
  • Known to be HIV positive, unless all of the following criteria are met:
  • Undetectable viral load or CD4+ count ≥300 cells/μL
  • Receiving highly active antiretroviral therapy
  • No AIDS-related illness within the past 12 months
  • Active liver disease (some exceptions are allowed)
  • Prior or ongoing condition, therapy, or laboratory abnormality that, in the investigator's opinion, may affect safety of the patient, confound the results of the study, and/or interfere with the patients participation in the study

Trial locations and contacts

18 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

MOMA Clinical Trials contact

(857) 285-3677

clinicaltrials@momatx.com

18 sites in 3 countries

United States12 sites, 8 recruiting

  • Investigative Site #112

    Fairfax, Virginia, 22031

    Completed

  • Investigative Site #108

    Goodyear, Arizona, 85338

    Recruiting

  • Investigative Site #101

    La Jolla, California, 92093

    Recruiting

  • Investigative Site #104

    Lake Mary, Florida, 32746

    Recruiting

  • Investigative Site #107

    Myrtle Beach, South Carolina, 29572

    Completed

  • Investigative Site #102

    Nashville, Tennessee, 37203

    Recruiting

  • Investigative Site #103

    New York, New York, 10016

    Recruiting

  • Investigative Site #106

    New York, New York, 10065

    Recruiting

  • Investigative Site #109

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Investigative Site #105

    San Antonio, Texas, 78229

    Completed

  • Investigative Site #111

    San Francisco, California, 94143

    Completed

  • Investigative Site #110

    St Louis, Missouri, 63110

    Recruiting

Other trials in United States

Spain3 sites, 3 recruiting

  • Investigative Site #114

    Barcelona

    Recruiting

  • Investigative Site #116

    Barcelona

    Recruiting

  • Investigative Site #115

    Madrid

    Recruiting

Other trials in Spain

United Kingdom3 sites, 3 recruiting

  • Investigative Site #113

    London

    Recruiting

  • Investigative Site #117

    Manchester

    Recruiting

  • Investigative Site #118

    Newcastle upon Tyne

    Recruiting

Other trials in United Kingdom

About this study

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

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.

Read the 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 (including locally), relapsed 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 (including locally), relapsed 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.

Being tested
MOMA-313, Olaparib
Keywords
Phase 1, MOMA-313, Polymerase theta, MOMA Therapeutics, Advanced Solid Tumor, Metastatic Solid Tumor, Prostate Cancer, Pancreas Cancer, Breast Cancer, Ovarian Cancer, Homologous Recombination Deficiency, HRD Mutation, Advanced (including locally)
Medical subject headings
Neoplasm Metastasis, Prostatic Neoplasms, Pancreatic Neoplasms, Breast Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOMA-313Drug

    MOMA-313 administered orally

  • OlaparibDrug

    Olaparib administered orally

Study groups in NCT06545942
Study groupRoleWhat they receive
MOMA-313 Monotherapy (Treatment Arm 1)ExperimentalMOMA-313 administered as a single-agent in 21-day cycles.
Receives: Drug: MOMA-313
MOMA-313 in Combination with Olaparib (Treatment Arm 2)ExperimentalMOMA-313 administered together with twice daily (BID) olaparib in 28-day cycles.
Receives: Drug: MOMA-313; Drug: Olaparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From screening until treatment discontinuation (up to 35 months)

Secondary outcomes (12)

  1. Identify the recommended phase 2 dose (RP2D)

    Determine the RP2D of MOMA-313 as a single-agent or in combination with olaparib

    Measured: From screening until treatment discontinuation (up to 35 months)

  2. PK parameter: area under curve (AUC) of MOMA-313

    Measured: Up to 6 weeks with sparse sampling up to 35 months

  3. PK parameter: maximum concentration (Cmax) of MOMA-313

    Measured: Up to 6 weeks with sparse sampling up to 35 months

  4. PK parameter: time to maximum concentration of MOMA-313

    Measured: Up to 6 weeks with sparse sampling up to 35 months

  5. PK parameter: half-life of MOMA-313

    Measured: Up to 6 weeks with sparse sampling up to 35 months

  6. Plasma concentration of olaparib

    Measured: Up to 6 weeks with sparse sampling up to 35 months

  7. 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).

    Measured: Up to 35 months

  8. 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

    Measured: Up to 35 months

  9. 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.

    Measured: Up to 35 months

  10. 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

    Measured: Up to 35 months

  11. 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.

    Measured: Up to 35 months

  12. 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

    Measured: Up to 35 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start13 Aug 2024
  3. Primary completion31 May 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06545942
Sponsor's protocol ID
MOMA-313-001
Status last verified
Jul 2026
First submitted
26 Jul 2024
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MOMA-313 and Olaparib in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by MOMA Therapeutics at 18 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact MOMA Clinical Trials ((857) 285-3677, clinicaltrials@momatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuation (time frame: From screening until treatment discontinuation (up to 35 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06545942.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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