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About
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.
Full 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.
Enrollment
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Volunteers
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
a. Prior anti-PD(L)1-based regimen is not required if participant is ineligible for anti-PD(L)1-based regimen (eg, due to autoimmune conditions)
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:
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
Primary purpose
Allocation
Interventional model
Masking
132 participants in 3 patient groups
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MOMA Clinical Trials
Data sourced from clinicaltrials.gov
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