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

Launched by MOMA THERAPEUTICS · Aug 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called MOMA-313, which is taken by mouth, to see how safe and effective it is for patients with advanced or metastatic solid tumors. These are cancers that have spread beyond their original location and cannot be treated with standard curative methods. The trial is looking specifically at patients with certain genetic changes that make their tumors more likely to respond to this treatment, including those with prostate, pancreatic, breast, and ovarian cancers.

To participate in the trial, patients must be at least 18 years old and have a confirmed diagnosis of one of the targeted cancers. They should have a measurable tumor and be in good overall health, meaning they have recovered from previous treatments. Participants will receive either MOMA-313 alone or in combination with another drug called Olaparib. Throughout the study, they will have regular check-ups to monitor their health and the effects of the medication. The trial is currently recruiting participants, so if you meet the criteria and are interested, it could be a valuable opportunity to explore new treatment options.

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Eligibility criteria

• 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 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 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: Metastatic prostate cancer, metastatic breast cancer, or metastatic pancreatic cancer 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