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

Cancer Categories

Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic

Karmanos Trial ID

2025-047

NCT ID

NCT06974110

Age Group

Adult

Scope

National

Phase

Phase I

Principal Investigator

Mohammed Najeeb
Al Hallak, M.D., MS
Oncology - Medical View Profile

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 MOMA341 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 MOMA341
To characterize preliminary evidence of antitumor activity associated with MOMA341 as monotherapy or in combination with chemotherapies or immunotherapies

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Eligibility

Eligibility

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)

Locations

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices