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RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests MOMA-341, a medicine taken by mouth, alone or with other treatments. It checks safety, how the body handles the medicine, and early signs that it works. It is for adults with solid tumors that cannot be removed by surgery or have spread and have certain DNA repair problems called MSI-H or dMMR.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Have a solid tumor confirmed by a tissue test, with MSI-H or dMMR DNA repair problems, that is advanced and cannot be removed by surgery or has spread.
  • Have cancer that worsened after anti-PD-(L)1 treatment, a type of immune therapy, unless you cannot receive it or it is not available in your region.
  • Have at least one tumor area that can be checked with repeat scans.
  • Be able to care for yourself and be out of bed or a chair for more than half of your waking hours.
  • Have fully recovered from important effects of past treatment or surgery. Hormone treatment and radiation to ease symptoms are allowed.
  • Have organs working well enough based on lab tests.
  • Follow birth control rules and sign a written form agreeing to join the study.

Who can't join

  • Have Werner syndrome, a condition that causes early aging.
  • Have another active, advanced cancer. Some exceptions apply, including for early-stage cancers.
  • Have significant heart or blood vessel disease, or cancer spread to the brain or spinal cord with worsening nerve-related symptoms. Stable steroid doses are allowed.
  • Have an active infection that is not controlled, or active liver disease. Some liver disease exceptions apply.
  • Have an allergy to MOMA-341, cannot tolerate it, or have digestive problems that may keep your body from absorbing it.
  • Are pregnant or breastfeeding.
  • Have HIV, unless you are on highly active HIV treatment, have had no AIDS-related illness in the past 12 months, and have either an undetectable virus level or a CD4 immune cell count of at least 300 cells/μL.
  • Have another condition, treatment, or abnormal lab result that the study doctor thinks could make the study unsafe, affect results, or keep you from taking part.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Age ≥ 18 years 2. 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 3. Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and/or PCWG-3 4. ECOG PS ≤ 2 5. Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and/or surgery \*\*hormonal therapy allowed. Palliative radiotherapy allowed 6. Adequate organ function per local labs 7. Comply with contraception requirements 8. Written informed consent must be obtained according to local guidelines Exclusion Criteria: 1. Known Werner Syndrome 2. Active prior or concurrent advanced-stage malignancy (some exceptions allowed including early-stage cancers) 3. Clinically relevant cardiovascular disease 4. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed) 5. Known active uncontrolled infection 6. Known allergy, hypersensitivity, and/or intolerance to MOMA-341 7. Impaired GI function that may impact absorption 8. Patient is pregnant or breastfeeding 9. Known to be HIV positive, unless all of the following criteria are met: 1. Undetectable viral load or CD4+ count ≥300 cells/μL 2. Receiving highly active antiretroviral therapy 3. No AIDS-related illness within the past 12 months 10. Active liver disease (some exceptions are allowed) 11. 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

Study sites (9)

AZ

CA

FL

MI

MO

NC

OR

TX