No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
MOMA Therapeutics · Industry
Who this trial is looking for
This trial is looking for adults with certain types of solid tumors to test a new medication called MOMA-313. Participants will receive this treatment either alone or with another drug, Olaparib, and will be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have a solid tumor that is not eligible for curative therapy.
I have one lesion that can be measured for the study.
I have recovered from previous treatments.
I have good organ function based on local lab tests.
I comply with contraception requirements.
I can give written informed consent.
You may not be able to join if
I have an active cancer other than my current diagnosis.
I have heart disease.
I have known brain metastasis with new symptoms.
I have a known active infection.
I am pregnant or breastfeeding.
I am HIV positive without meeting specific health criteria.
I have active liver disease.
I cannot safely take the required medications.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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-def…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.