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MOMA-313 + Olaparib for Solid Tumors

Phase 1
Recruiting
Research Sponsored by MOMA Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Treatment Arm 1 (MOMA-313 Monotherapy): Advanced or metastatic solid tumors not eligible for curative therapy with any HR-deficient alteration, previously exposed to a PARP inhibitor.
ECOG PS ≤ 2
Must not have
Prior polymerase theta inhibitor exposure
Clinically relevant cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 35 months
Awards & highlights

Summary

This trial is testing a new drug called MOMA-313 in patients with certain types of solid tumors. The study will look at how safe the drug is, how well it is tolerated, how the

Who is the study for?
This trial is for adults with advanced or metastatic solid tumors, such as pancreatic, prostate, ovarian, and breast cancers. Participants must have a deficiency in homologous recombination repair mechanisms within their tumor cells.
What is being tested?
The study tests the safety and effects of MOMA-313 taken by mouth alone or combined with Olaparib. It's an early-phase trial to find the right dose and see how these drugs affect participants' bodies (PK/PDx) and their cancer.
What are the potential side effects?
Possible side effects include nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems, allergic reactions to medication components, kidney or liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced cancer cannot be cured and has a specific genetic change. I've had PARP inhibitor treatment.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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I have metastatic cancer with specific gene mutations and haven't taken PARP inhibitors.
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I have at least one tumor that can be measured with imaging tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with a polymerase theta inhibitor before.
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I have heart problems that affect my daily life.
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I have had a bad reaction to PARP inhibitors like Olaparib.
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I am on effective HIV medication.
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I currently have an active infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 35 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 35 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuation
Secondary study objectives
Disease control rate (DCR)
Duration of response (DOR)
Identify the recommended phase 2 dose (RP2D)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: MOMA-313 in Combination with Olaparib (Treatment Arm 2)Experimental Treatment2 Interventions
MOMA-313 administered together with twice daily (BID) olaparib in 28-day cycles.
Group II: MOMA-313 Monotherapy (Treatment Arm 1)Experimental Treatment1 Intervention
MOMA-313 administered as a single-agent in 21-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2190

Find a Location

Who is running the clinical trial?

MOMA TherapeuticsLead Sponsor
~105 spots leftby May 2027
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