RightFit
RecruitingPhase 1

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

A Phase 1 Study of MOMA-313 Given as Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests MOMA-313, a medicine taken by mouth, alone or with olaparib. It checks safety, doses, how the medicine works in the body, and early signs that it may treat cancer. It is for adults with advanced solid tumors that have changes in genes that help repair damaged DNA.

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-313 administered orally as a single agent or combination therapy in patients with homologous recombinant deficient solid tumors.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, with cancer confirmed by a tissue test.
  • For MOMA-313 alone: have a solid tumor that has grown nearby, returned, or spread, cannot be treated to cure it, and has a DNA-repair gene change called HR deficiency.
  • For early testing of MOMA-313 with olaparib: have an advanced, returned, or spread solid tumor that cannot be treated to cure it, with certain HR gene changes. A PARP inhibitor, a type of cancer drug, must be a treatment option. Past use is allowed.
  • For testing the best dose with olaparib: have advanced, returned, or spread prostate cancer that resists hormone-lowering treatment, or pancreatic ductal cancer. Certain HR gene changes are required, and you must not have used a PARP inhibitor.
  • Have at least one tumor area that can be checked with repeat scans.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • Have recovered from important effects of past treatment or surgery, and have organs working well enough on lab tests. Hormone treatment and radiation to ease symptoms are allowed.
  • Follow birth control rules and sign a form agreeing to join the study.

Who can't join

  • Have another active cancer or active liver disease. Some exceptions are allowed.
  • Have heart or blood vessel disease that matters for study safety, or a known active infection.
  • Have cancer spread to the brain or spinal cord with worsening nerve-related symptoms. Stable doses of steroid medicines are allowed.
  • Have used a polymerase theta inhibitor, a drug that blocks a DNA-repair protein.
  • Have a known allergy or intolerance to MOMA-313. For the olaparib group, people who have used olaparib cannot have a known allergy to PARP inhibitors.
  • Have digestive problems that may keep the medicine from being absorbed, or be pregnant or breastfeeding.
  • Have HIV, unless you are on combination HIV treatment, have had no AIDS-related illness in the past 12 months, and have either an undetectable virus level or a CD4 immune cell count of at least 300 cells/μL.
  • Have another condition, treatment, or abnormal lab result that the study doctor thinks could affect your safety, the study results, or your ability to take part.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 (including locally), relapsed 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 (including locally), relapsed 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: Advanced (including locally), relapsed or metastatic CRPC or pancreatic ductal adenocarcinoma (PDAC) 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

Study sites (12)

AZ

CA

FL

MO

NY

PA

SC

TN

TX

VA