Clinical Trial 23660

• Overview

  Study Title:

  A Phase 1 Study of MOMA-341 as Monotherapy or Combination Therapy in Participants with Advanced or Metastatic Solid Tumors

  Summary:

  This Phase 1, 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.

  Objective:

  Primary Objective: - To characterize the safety and tolerability of MOMA-341 as monotherapy or in combination with chemotherapy or immunotherapies Secondary Objectives: - To identify the RP2D(s) and/or recommended optimization doses of MOMA-341 as monotherapy and in combination with chemotherapies or immunotherapies - To characterize the PK profile of MOMA-341 when administered as monotherapy and in combination with chemotherapies or immunotherapies - To assess the effects of food on the PK parameters of MOMA-341 (for select participants only) - To characterize the PK profile of irinotecan and its active metabolite SN-38 when administered in combination with MOMA-341 - To characterize preliminary evidence of antitumor activity associated with MOMA-341 as monotherapy or in combination with chemotherapies or immunotherapies

• Treatments

  Therapies:

  Chemotherapy (NOS); Immunotherapy; Selective inhibitor of the WRN helicase

• Inclusion 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 regimen, a. Prior anti-PD(L)1-based regimen is not required if participant is ineligible for anti-PD(L)1-based regimen (eg, due to autoimmune conditions)
  • Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and/or PCWG-3
  • ECOG PS > 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

• Exclusion Criteria

  • 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 in the study

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