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Advanced Solid TumorPhase 1NCT06974110

Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors

A Phase 1 study testing MOMA-341, Irinotecan and Immunotherapy in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by MOMA Therapeutics at 15 sites in 2 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-341 administered orally as a single agent or combination therapy in patients with microsatellite… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MOMA-341, Irinotecan and Immunotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
15 sitesin 2 countries
Study dates
16 Jul 2025to May 2028
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
  • Participants have unresectable advanced or metastatic solid tumors with MSI-H or dMMR alterations and histologically confirmed disease. Participants must have previously received and progressed on an anti-PD-(L)1-based regimen, unless ineligible or in a region without access to anti-PD-(L)1 therapies
  • 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

  • Known Werner Syndrome
  • Active prior or concurrent advanced-stage malignancy (some exceptions allowed including early-stage cancers)
  • Clinically relevant cardiovascular disease
  • Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)
  • Known active uncontrolled infection
  • Known allergy, hypersensitivity, and/or intolerance to MOMA-341
Show all 14Show fewer
  • 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

15 sites in 2 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

15 sites in 2 countries

United States9 sites, 8 recruiting

  • Investigative Site #127

    Dallas, Texas, 75230

    Completed

  • Investigative Site #120

    Detroit, Michigan, 48201

    Recruiting

  • Investigative Site #129

    Houston, Texas, 77030

    Recruiting

  • Investigative Site #132

    Phoenix, Arizona, 85054

    Recruiting

  • Investigative Site #121

    Portland, Oregon, 97239

    Recruiting

  • Investigative Site #131

    Raleigh, North Carolina, 27710

    Recruiting

  • Investigative Site #101

    San Diego, California, 92037

    Recruiting

  • Investigative Site #110

    St Louis, Missouri, 63108

    Recruiting

  • Investigative Site #128

    Tampa, Florida, 33612

    Recruiting

Other trials in United States

Australia6 sites, 5 recruiting

  • Investigative Site #125

    Adelaide, South Australia, 5000

    Recruiting

  • Investigative Site #126

    Clayton, Victoria, 3168

    Recruiting

  • Investigative Site #119

    Perth, Western Australia, 6009

    Recruiting

  • Investigative Site #122

    Sydney, New South Wales, 2031

    Recruiting

  • Investigative Site #123

    Westmead, New South Wales, 2145

    Recruiting

  • Investigative Site #124

    Woolloongabba, Queensland, 4102

    Completed

Other trials in Australia

About this study

Official title: A Phase 1 Study of MOMA-341 as Monotherapy or Combination Therapy 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-341 administered orally as a single agent or combination therapy in patients with microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors.

Read the detailed description

MOMA-341 is a novel therapeutic agent designed to target microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) cancers by inhibiting Werner helicase. MOMA-341 is being developed as a single agent and in combination with either chemotherapy or immunotherapy in patients with certain advanced or metastatic solid tumors.

This phase 1, first-in-human, open-label study of MOMA-341 is primarily intended to evaluate the safety and tolerability of MOMA-341 when administered orally as a single agent (Treatment Arm 1), in combination with irinotecan (Treatment Arm 2), or in combination with immunotherapy (Treatment Arm 3). Each treatment arm of the study includes a dose-escalation phase, which means successive cohorts of patients will receive increasing oral doses of MOMA-341 as a single agent or in combination with irinotecan or immunotherapy to determine the presumptive optimal biologic dose(s) (OBD) in this population. The study also includes a dose-optimization phase that will enroll additional patients to support the confirmation of the OBD.

The data from this study conducted in patients with MSI-H or dMMR advanced or metastatic solid tumors, including safety, tolerability, PK/PDx findings, and antitumor activity, will form the basis for subsequent clinical development of MOMA-341 as a single-agent and in combination with irinotecan or immunotherapy.

Being tested
MOMA-341, Irinotecan, Immunotherapy
Keywords
Phase 1, MOMA-341, Werner helicase, WRN, Advanced Solid Tumor, Metastatic Solid Tumor, Gastric Cancer, Colorectal Cancer, Endometrial Cancer, MSI-H Cancer, dMMR Cancer
Medical subject headings
Neoplasm Metastasis, Endometrial Neoplasms, Colorectal Neoplasms, Stomach Neoplasms

What participants receive

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

  • MOMA-341Drug

    MOMA-341 administered orally

  • IrinotecanDrug

    Irinotecan administered by IV infusion

  • ImmunotherapyDrug

    Immunotherapy administered by IV infusion

Study groups in NCT06974110
Study groupRoleWhat they receive
MOMA-341 Monotherapy (Treatment Arm 1)ExperimentalMOMA-341 administered as a single agent in 21-day cycles
Receives: Drug: MOMA-341
MOMA-341 in Combination with Irinotecan (Treatment Arm 2)ExperimentalMOMA-341 administered together with irinotecan in 28-day cycles
Receives: Drug: MOMA-341; Drug: Irinotecan
MOMA-341 in Combination with Immunotherapy (Treatment Arm 3)ExperimentalMOMA-341 administered together with immunotherapy in 21-day cycles
Receives: Drug: MOMA-341; Drug: Immunotherapy

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-341 given as a single-agent, and in combination with irinotecan, and in combination with immunotherapy

    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-341 as a single-agent, and in combination with irinotecan, and in combination with immunotherapy

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

  2. PK parameter; area under curve (AUC) of MOMA-341

    Determine the AUC of MOMA-341 as a single-agent, and in combination with irinotecan, and in combination with immunotherapy

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

  3. PK parameter; maximum concentration (Cmax) of MOMA-341

    Determine the Cmax of MOMA-341 as a single-agent, and in combination with irinotecan, and in combination with immunotherapy

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

  4. PK parameter; time to maximum concentration (Tmax) of MOMA-341

    Determine the Tmax of MOMA-341 as a single-agent, and in combination with irinotecan, and in combination with immunotherapy

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

  5. PK parameter; half-life (T1/2) of MOMA-341

    Determine the T1/2 of MOMA-341 as a single-agent, and in combination with irinotecan, and in combination with immunotherapy

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

  6. PK parameter; plasma exposure of irinotecan

    Determine the plasma exposure of irinotecan in combination with MOMA-341

    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 defined as the time from first dose of study treatment to progressive disease or death from any cause, whichever is earlier, as assessed by RECIST 1.1 and/or PCWG-3 by investigator assessment

    Measured: Up to 35 months

  11. Disease control rate (DCR)

    DCR is defined as the proportion of subjects who achieved either CR, PR, or stable disease (SD) at the 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 posted15 May 2025
  2. Study start16 Jul 2025
  3. Primary completionNov 2027 (estimated)
  4. Study completionMay 2028 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06974110
Sponsor's protocol ID
MOMA-341-001
Status last verified
Jul 2026
First submitted
2 May 2025
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-341, Irinotecan and Immunotherapy in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by MOMA Therapeutics at 15 sites in 2 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 8 inclusion and 14 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 15 sites in United States, Australia. 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 NCT06974110.

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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