Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors

NCT06545942
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
220
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Lead sponsor
MOMA Therapeutics
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Start date
2024-08-13
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Number of sites
18
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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-313 administered orally as a single agent or combination therapy in patients with homologous recombinant deficient solid tumors.
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Short title
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
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Official title
A Phase 1 Study of MOMA-313 Given as Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-11-30
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First posted
2024-08-09
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Registry last updated
2026-07-23
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Primary completion date
2027-05-31
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Start date
2024-08-13
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Participants
220
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Participant count basis
Estimated
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Planned participants
220
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Protocol amendments
4
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Number of sites
18
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
MOMA Therapeutics
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06545942
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ClinicalTrials.gov ID
NCT06545942
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
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-313 given as a single-agent or in combination with olaparib

  1. Identify the recommended phase 2 dose (RP2D)

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

    Determine the RP2D of MOMA-313 as a single-agent or in combination with olaparib

  2. PK parameter: area under curve (AUC) of MOMA-313

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

  3. PK parameter: maximum concentration (Cmax) of MOMA-313

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

  4. PK parameter: time to maximum concentration of MOMA-313

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

  5. PK parameter: half-life of MOMA-313

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

  6. Plasma concentration of olaparib

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

  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 time from first dose of study treatment to progressive disease or death from any cause, whichever is earlier, as assessed via RECIST v1.1 and/or PCWG-3 by Investigator assessment

  11. Disease control rate (DCR)

    Timeframe: Up to 35 months

    DCR defined by the proportion of subjects who achieved either a complete response (CR), partial response (PR), or stable disease (SD) at their 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

Key Inclusion Criteria:

  1. Age ≥ 18 years

  2. Have histologically confirmed disease for each treatment arm as follows:

    1. Treatment Arm 1 (MOMA-313 Monotherapy)

      - Advanced (including locally), relapsed or metastatic solid tumors that are not eligible for curative therapy, with any HR-deficient alteration.

    2. Treatment Arm 2 (MOMA-313 in Combination with Olaparib):

      • Dose escalation: Advanced (including locally), relapsed or metastatic solid tumors that are not eligible for curative therapy, for which a PARP inhibitor is indicated, with select HR-deficient mutations. Patients may be PARP inhibitor naive or exposed.
      • Dose optimization: Advanced (including locally), relapsed or metastatic CRPC or pancreatic ductal adenocarcinoma (PDAC) with select HR-deficient mutations. Patients must be PARP inhibitor naive.

  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

Key Exclusion Criteria:

  1. Active prior or concurrent malignancy (some exceptions allowed)

  2. Clinically relevant cardiovascular disease

  3. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)

  4. Known active infection

  5. Prior polymerase theta inhibitor exposure

  6. Known allergy, hypersensitivity, and/or intolerance to MOMA-313

  7. Olaparib exposed patients with known hypersensitivity to PARP inhibitors (for patients considered for olaparib only)

  8. Impaired GI function that may impact absorption.

  9. Patient is pregnant or breastfeeding.

  10. 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

  11. Active liver disease (some exceptions are allowed)

  12. 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 #108Goodyear, United StatesRecruiting
  • Investigative Site #101La Jolla, United StatesRecruiting
  • Investigative Site #111San Francisco, United StatesCompleted
  • Investigative Site #104Lake Mary, United StatesRecruiting
  • Investigative Site #110St Louis, United StatesRecruiting
  • Investigative Site #103New York, United StatesRecruiting
  • Investigative Site #106New York, United StatesRecruiting
  • Investigative Site #109Philadelphia, United StatesRecruiting
  • Investigative Site #107Myrtle Beach, United StatesCompleted
  • Investigative Site #102Nashville, United StatesRecruiting
  • Investigative Site #105San Antonio, United StatesCompleted
  • Investigative Site #112Fairfax, United StatesCompleted
  • Investigative Site #114Barcelona, SpainRecruiting
  • Investigative Site #116Barcelona, SpainRecruiting
  • Investigative Site #115Madrid, SpainRecruiting
  • Investigative Site #113London, United KingdomRecruiting
  • Investigative Site #117Manchester, United KingdomRecruiting
  • Investigative Site #118Newcastle upon Tyne, United KingdomRecruiting
Sources for sites
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Related records

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