Tests oral MOMA-313 alone or with olaparib in advanced solid tumors
Tests oral MOMA-313, alone or with olaparib, in adults with advanced solid tumors.
Plain-language title generated from the registry record
Registry title: Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
Key facts
- Where
- Barcelona and Madrid, SpainSee the 3 sites
- Phase
- Phase 1
Where in Spain
- BarcelonaBarcelona, SpainTaking people
- BarcelonaBarcelona, SpainTaking people
- MadridMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- MOMA Therapeutics
- Trial code
- NCT06545942
- Record updated
- 23 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age ≥ 18 years; Have histologically confirmed disease for each treatment arm as follows:; 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; 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; 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: Active prior or concurrent malignancy (some exceptions allowed); Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed); Prior polymerase theta inhibitor exposure; Clinically relevant cardiovascular disease; Known active infection; Known allergy, hypersensitivity, and/or intolerance to MOMA-313; Olaparib exposed patients with known hypersensitivity to PARP inhibitors (for patients considered for olaparib only); Active liver disease (some exceptions are allowed); 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; 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; Impaired GI function that may impact absorption; Patient is pregnant or breastfeeding.