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

a study on Solid Tumor Prostate Cancer Pancreatic Cancer Breast Cancer Ovarian Cancer Homologous Recombination Deficiency Neoplasms Pancreatic Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Rahul Aggarwal (ucsf)
Headshot of Rahul Aggarwal
Rahul Aggarwal

Description

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.

Official Title

A Phase 1 Study of MOMA-313 Given as Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors

Details

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.

Keywords

Advanced Solid Tumor, Metastatic Solid Tumor, Prostate Cancer, Pancreas Cancer, Breast Cancer, Ovarian Cancer, Homologous Recombination Deficiency, Phase 1, MOMA-313, Polymerase theta, MOMA Therapeutics, HRD Mutation, Neoplasms, Prostatic Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Olaparib

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age ≥ 18 years
  2. Have histologically confirmed disease for each treatment arm as follows:
    1. Treatment Arm 1 (MOMA-313 Monotherapy)
    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

You CAN'T join if...

  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

Locations

  • Investigative Site #101 accepting new patients
    La Jolla California 92093 United States
  • Investigative Site #105 accepting new patients
    San Antonio Texas 78229 United States

Lead Scientist at University of California Health

  • Rahul Aggarwal (ucsf)
    I am a Medical Oncologist within the Division of Hematology/Oncology at the University of California San Francisco. My clinical practice focuses on patients with advanced solid tumor malignancies with a particular emphasis on genitourinary malignancies including prostate, kidney, bladder, and testicular cancer.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MOMA Therapeutics
ID
NCT06545942
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 158 study participants
Last Updated