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Recruiting NCT06974110

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

Phase I Interventional Advanced Solid Tumor Metastatic Solid Tumor Endometrial Cancer MSI-H Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MOMA-341, Irinotecan, Immunotherapy.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor, Metastatic Solid Tumor, Endometrial Cancer, MSI-H Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

MOMA-341 is a novel therapeutic agent designed to target microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) cancers by inhibiting Werner helicase. MOMA-341 is being developed as a single agent and in combination with either chemotherapy or immunotherapy in patients with certain advanced or metastatic solid tumors.

This phase 1, first-in-human, open-label study of MOMA-341 is primarily intended to evaluate the safety and tolerability of MOMA-341 when administered orally as a single agent (Treatment Arm 1), in combination with irinotecan (Treatment Arm 2), or in combination with immunotherapy (Treatment Arm 3). Each treatment arm of the study includes a dose-escalation phase, which means successive cohorts of patients will receive increasing oral doses of MOMA-341 as a single agent or in combination with irinotecan or immunotherapy to determine the presumptive optimal biologic dose(s) (OBD) in this population. The study also includes a dose-optimization phase that will enroll additional patients to support the confirmation of the OBD.

The data from this study conducted in patients with MSI-H or dMMR advanced or metastatic solid tumors, including safety, tolerability, PK/PDx findings, and antitumor activity, will form the basis for subsequent clinical development of MOMA-341 as a single-agent and in combination with irinotecan or immunotherapy.

Interventions

  • Drug MOMA-341
    MOMA-341 administered orally
  • Drug Irinotecan
    Irinotecan administered by IV infusion
  • Drug Immunotherapy
    Immunotherapy administered by IV infusion

Primary outcome measures

  • Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuation [Time frame: From screening until treatment discontinuation (up to 35 months)]
Secondary outcome measures (12)
  • Identify the recommended phase 2 dose (RP2D) [Time frame: From screening until treatment discontinuation (up to 35 months)]
  • PK parameter; area under curve (AUC) of MOMA-341 [Time frame: Up to 6 weeks with sparse sampling up to 35 months]
  • PK parameter; maximum concentration (Cmax) of MOMA-341 [Time frame: Up to 6 weeks with sparse sampling up to 35 months]
  • PK parameter; time to maximum concentration (Tmax) of MOMA-341 [Time frame: Up to 6 weeks with sparse sampling up to 35 months]
  • PK parameter; half-life (T1/2) of MOMA-341 [Time frame: Up to 6 weeks with sparse sampling up to 35 months]
  • PK parameter; plasma exposure of irinotecan [Time frame: Up to 6 weeks with sparse sampling up to 35 months]
  • Objective response rate (ORR) [Time frame: Up to 35 months]
  • Duration of response (DOR) [Time frame: Up to 35 months]
  • Time to response (TTR) [Time frame: Up to 35 months]
  • Progression free survival (PFS) [Time frame: Up to 35 months]
  • Disease control rate (DCR) [Time frame: Up to 35 months]
  • Overall survival (OS) [Time frame: Up to 35 months]

Eligibility criteria

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, unless ineligible or in a region without access to anti-PD-(L)1 therapies
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 9 centers
  • Investigative Site #132 — Phoenix
  • Investigative Site #101 — San Diego
  • Investigative Site #128 — Tampa
  • Investigative Site #120 — Detroit
  • Investigative Site #110 — St Louis
  • Investigative Site #131 — Raleigh
  • Investigative Site #121 — Portland
  • Investigative Site #127 — Dallas
  • … and 1 more center
Australia · 6 centers
  • Investigative Site #122 — Sydney
  • Investigative Site #123 — Westmead
  • Investigative Site #124 — Woolloongabba
  • Investigative Site #125 — Adelaide
  • Investigative Site #126 — Clayton
  • Investigative Site #119 — Perth

Identifiers

NCT: NCT06974110 · MOMA-341-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗