NCT06974110RecruitingPhase 1
Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors
A Phase 1 Study of MOMA-341 as Monotherapy or Combination Therapy in Participants With Advanced or Metastatic Solid Tumors
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 2 May 2025
- Start date
- 16 Jul 2025
- Primary completion date
- Nov 2027
- Lead sponsor
- MOMA Therapeutics
- NCT number
- NCT06974110
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 132
- From 16 Jul 2025 to the primary completion date, Nov 2027
- 15 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active prior or concurrent advanced-stage malignancy (some exceptions allowed including early-stage cancers)
- Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)
Other illness
- Known Werner Syndrome
- Clinically relevant cardiovascular disease
- Known active uncontrolled infection
- Known allergy, hypersensitivity, and/or intolerance to MOMA-341
- Active liver disease (some exceptions are allowed)
Lab values
- 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
- 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
Other
- Impaired GI function that may impact absorption
- Patient is pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.