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New treatment option for Advanced Solid Tumor
Official title Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06974110
What this study is testing
What is MOMA-341?
MOMA-341 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Participants have unresectable advanced or metastatic solid tumors with MSI-H or dMMR alterations and histologically confirmed disease. Participants...
- 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...
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- 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
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Tampa, Florida, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Raleigh, North Carolina, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Sydney, New South Wales, Australia
- Westmead, New South Wales, Australia
- Woolloongabba, Queensland, Australia
- Adelaide, South Australia, Australia
- Clayton, Victoria, Australia
- Perth, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Tampa, Florida, United States; Detroit, Michigan, United States; St Louis, Missouri, United States; Raleigh, North Carolina, United States; Portland, Oregon, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.