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

ConditionsAdvanced Solid TumorMetastatic Solid TumorEndometrial CancerMSI-H CancerColorectal CancerGastric CancerdMMR Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMOMA Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • MOMA-341

    Drug

    MOMA-341 administered orally

  • Irinotecan

    Drug

    Irinotecan administered by IV infusion

  • Immunotherapy

    Drug

    Immunotherapy administered by IV infusion

Treatment groups

132 Participants
are divided into 3 treatment groups
Group A: MOMA-341 Monotherapy (Treatment Arm 1)Experimental treatment 1 intervention
Group B: MOMA-341 in Combination with Irinotecan (Treatment Arm 2)Experimental treatment 2 interventions
Group C: MOMA-341 in Combination with Immunotherapy (Treatment Arm 3)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
From screening until treatment discontinuation (up to 35 months)

Secondary outcomes

1

Identify the recommended phase 2 dose (RP2D)

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

Time frame
From screening until treatment discontinuation (up to 35 months)
2

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

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

Time frame
Up to 6 weeks with sparse sampling up to 35 months
3

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

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

Time frame
Up to 6 weeks with sparse sampling up to 35 months
4

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

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

Time frame
Up to 6 weeks with sparse sampling up to 35 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MOMA Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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