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

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
MOMA Therapeutics
Study ID
NCT06545942
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MOMA-313 — DRUG
    MOMA-313 administered orally
  • Olaparib — DRUG
    Olaparib administered orally

Study Details

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.

Key Dates

Start date
Aug 13, 2024
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
220 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: MOMA-313 Monotherapy (Treatment Arm 1)
    MOMA-313 administered as a single-agent in 21-day cycles.
  • Experimental: MOMA-313 in Combination with Olaparib (Treatment Arm 2)
    MOMA-313 administered together with twice daily (BID) olaparib in 28-day cycles.

Primary Outcome Measure

Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuation [ Time Frame: From screening until treatment discontinuation (up to 35 months) ]

Locations (12)

FacilityCityStateZIPSite coordinators
Investigative Site #108GoodyearArizona85338-
Investigative Site #101La JollaCalifornia92093-
Investigative Site #111San FranciscoCalifornia94143-
Investigative Site #104Lake MaryFlorida32746-
Investigative Site #110St LouisMissouri63110-
Investigative Site #103New YorkNew York10016-
Investigative Site #106New YorkNew York10065-
Investigative Site #109PhiladelphiaPennsylvania19104-
Investigative Site #107Myrtle BeachSouth Carolina29572-
Investigative Site #102NashvilleTennessee37203-
Investigative Site #105San AntonioTexas78229-
Investigative Site #112FairfaxVirginia22031-

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