Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
Start Date
8/13/2024
Completion Date
11/30/2027
Summary
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.
Detailed Description
MOMA-313 is a novel therapeutic agent designed to target homologous recombination (HR)-deficient cancers by inhibiting DNA polymerase theta. MOMA-313 is being developed as a single-agent and in combination with a poly (adenosine diphosphate ribose) polymerase (PARP) inhibitor in patients with HR-deficient advanced (including locally), relapsed or metastatic solid tumors. This phase 1, first-in-human, open-label study of MOMA-313 is primarily intended to evaluate the safety and tolerability of MOMA-313 when administered orally as a single agent (Treatment Arm 1) or in combination with olaparib (Treatment Arm 2). Each treatment arm of the study includes a dose-escalation phase followed by a dose-optimization phase. In the dose-escalation phase of each treatment arm, successive cohorts of patients will receive increasing oral doses of MOMA-313 as a single agent or in combination with olaparib to determine the presumptive optimal biologic dose(s) (OBD) in this population. The dose-optimization phase of each arm will enroll additional patients to support the confirmation of the OBD. The data from this study conducted in patients with HR-deficient advanced (including locally), relapsed or metastatic solid tumors, including safety, tolerability, PK/PDx findings, and antitumor activity, will form the basis for subsequent clinical development of MOMA-313 as a single-agent and in combination with olaparib.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
MOMA-313
Olaparib
Conditions
Locations
Investigative Site #108
Goodyear, Arizona 85338
United States
Investigative Site #101
La Jolla, California 92093
United States
Investigative Site #111
San Francisco, California 94143
United States
Investigative Site #104
Lake Mary, Florida 32746
United States
Investigative Site #110
St Louis, Missouri 63110
United States
Investigative Site #103
New York, New York 10016
United States
Investigative Site #106
New York, New York 10065
United States
Investigative Site #109
Philadelphia, Pennsylvania 19104
United States
Investigative Site #107
Myrtle Beach, South Carolina 29572
United States
Investigative Site #102
Nashville, Tennessee 37203
United States
Investigative Site #105
San Antonio, Texas 78229
United States
Investigative Site #112
Fairfax, Virginia 22031
United States
Investigative Site #114
Barcelona,
Spain
Investigative Site #116
Barcelona,
Spain
Investigative Site #115
Madrid,
Spain
Investigative Site #113
London,
United Kingdom
Investigative Site #117
Manchester,
United Kingdom
Investigative Site #118
Newcastle upon Tyne,
United Kingdom