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Trial Title:
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
NCT ID:
NCT06545942
Condition:
Advanced Solid Tumor
Metastatic Solid Tumor
Prostate Cancer
Pancreas Cancer
Breast Cancer
Ovarian Cancer
Homologous Recombination Deficiency
Conditions: Official terms:
Neoplasms
Prostatic Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Olaparib
Conditions: Keywords:
Phase 1
MOMA-313
Polymerase theta
MOMA Therapeutics
Advanced Solid Tumor
Metastatic Solid Tumor
Prostate Cancer
Pancreas Cancer
Breast Cancer
Ovarian Cancer
Homologous Recombination Deficiency
HRD Mutation
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MOMA-313
Description:
MOMA-313 administered orally
Arm group label:
MOMA-313 Monotherapy (Treatment Arm 1)
Arm group label:
MOMA-313 in Combination with Olaparib (Treatment Arm 2)
Intervention type:
Drug
Intervention name:
Olaparib
Description:
Olaparib administered orally
Arm group label:
MOMA-313 in Combination with Olaparib (Treatment Arm 2)
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 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 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.
Criteria for 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 or metastatic solid tumors that are not eligible for curative
therapy, with any HR-deficient alteration, and have been previously
exposed to a PARP inhibitor.
2. Treatment Arm 2 (MOMA-313 in Combination with Olaparib):
- Dose escalation: Advanced 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: Metastatic prostate cancer, metastatic breast cancer,
or metastatic pancreatic cancer 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 significant toxicity or 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Investigative Site
Address:
City:
Myrtle Beach
Zip:
29572
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Start date:
August 13, 2024
Completion date:
November 30, 2027
Lead sponsor:
Agency:
MOMA Therapeutics
Agency class:
Industry
Source:
MOMA Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06545942
