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

NCT06974110
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
132
clinicaltrials.gov
Lead sponsor
MOMA Therapeutics
clinicaltrials.gov
Start date
2025-07-16
clinicaltrials.gov
Number of sites
15
clinicaltrials.gov

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 instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors.
clinicaltrials.gov
Short title
Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors
clinicaltrials.gov
Official title
A Phase 1 Study of MOMA-341 as Monotherapy or Combination Therapy in Participants With Advanced or Metastatic Solid Tumors
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2028-05-01
clinicaltrials.gov
First posted
2025-05-15
clinicaltrials.gov
Registry last updated
2026-07-23
clinicaltrials.gov
Primary completion date
2027-11-01
clinicaltrials.gov
Start date
2025-07-16
clinicaltrials.gov

Participants
132
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
132
clinicaltrials.gov
Protocol amendments
1
clinicaltrials.gov
Number of sites
15
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
MOMA Therapeutics
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06974110
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06974110
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuation

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

    To assess the safety and tolerability of MOMA-341 given as a single-agent, and in combination with irinotecan, and in combination with immunotherapy

  1. Identify the recommended phase 2 dose (RP2D)

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

    Determine the RP2D of MOMA-341 as a single-agent, and in combination with irinotecan, and in combination with immunotherapy

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

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

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

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

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

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

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

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

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

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

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

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

  6. PK parameter; plasma exposure of irinotecan

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

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

  7. Objective response rate (ORR)

    Timeframe: Up to 35 months

    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)

  8. Duration of response (DOR)

    Timeframe: Up to 35 months

    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

  9. Time to response (TTR)

    Timeframe: Up to 35 months

    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)

  10. Progression free survival (PFS)

    Timeframe: Up to 35 months

    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

  11. Disease control rate (DCR)

    Timeframe: Up to 35 months

    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

  12. Overall survival (OS)

    Timeframe: Up to 35 months

    OS is defined as the time from first dose of study treatment to the date of death, irrespective of the cause of death

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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

  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

Sources for eligibility
clinicaltrials.gov

  • Investigative Site #132Phoenix, United StatesRecruiting
  • Investigative Site #101San Diego, United StatesRecruiting
  • Investigative Site #128Tampa, United StatesRecruiting
  • Investigative Site #120Detroit, United StatesRecruiting
  • Investigative Site #110St Louis, United StatesRecruiting
  • Investigative Site #131Raleigh, United StatesRecruiting
  • Investigative Site #121Portland, United StatesRecruiting
  • Investigative Site #127Dallas, United StatesCompleted
  • Investigative Site #129Houston, United StatesRecruiting
  • Investigative Site #122Sydney, AustraliaRecruiting
  • Investigative Site #123Westmead, AustraliaRecruiting
  • Investigative Site #124Woolloongabba, AustraliaCompleted
  • Investigative Site #125Adelaide, AustraliaRecruiting
  • Investigative Site #126Clayton, AustraliaRecruiting
  • Investigative Site #119Perth, AustraliaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (7)

Targets (1)