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Recruiting NCT06545942

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

Phase I Interventional Advanced Solid Tumor Metastatic Solid Tumor Prostate Cancer Pancreas Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MOMA-313, Olaparib.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor, Metastatic Solid Tumor, Prostate Cancer, Pancreas Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Spain, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug MOMA-313
    MOMA-313 administered orally
  • Drug Olaparib
    Olaparib administered orally

Primary outcome measures

  • 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)]
Secondary outcome measures (12)
  • Identify the recommended phase 2 dose (RP2D) [Time frame: From screening until treatment discontinuation (up to 35 months)]
  • PK parameter: area under curve (AUC) of MOMA-313 [Time frame: Up to 6 weeks with sparse sampling up to 35 months]
  • PK parameter: maximum concentration (Cmax) of MOMA-313 [Time frame: Up to 6 weeks with sparse sampling up to 35 months]
  • PK parameter: time to maximum concentration of MOMA-313 [Time frame: Up to 6 weeks with sparse sampling up to 35 months]
  • PK parameter: half-life of MOMA-313 [Time frame: Up to 6 weeks with sparse sampling up to 35 months]
  • Plasma concentration of olaparib [Time frame: Up to 6 weeks with sparse sampling up to 35 months]
  • Objective response rate (ORR) [Time frame: Up to 35 months]
  • Duration of response (DOR) [Time frame: Up to 35 months]
  • Time to response (TTR) [Time frame: Up to 35 months]
  • Progression free survival (PFS) [Time frame: Up to 35 months]
  • Disease control rate (DCR) [Time frame: Up to 35 months]
  • Overall survival (OS) [Time frame: Up to 35 months]

Eligibility criteria

Inclusion criteria

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

\- Advanced (including locally), relapsed or metastatic solid tumors that are not eligible for curative therapy, with any HR-deficient alteration.

  • Treatment Arm 2 (MOMA-313 in Combination with Olaparib):
  • Dose escalation: Advanced (including locally), relapsed 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: Advanced (including locally), relapsed or metastatic CRPC or pancreatic ductal adenocarcinoma (PDAC) with select HR-deficient mutations. Patients must be PARP inhibitor naive.
  • Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and/or PCWG-3
  • ECOG PS ≤ 2
  • Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and/or surgery \*\*hormonal therapy allowed. Palliative radiotherapy allowed.
  • Adequate organ function per local labs
  • Comply with contraception requirements
  • Written informed consent must be obtained according to local guidelines

Exclusion criteria

  • Active prior or concurrent malignancy (some exceptions allowed)
  • Clinically relevant cardiovascular disease
  • Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)
  • Known active infection
  • Prior polymerase theta inhibitor exposure
  • Known allergy, hypersensitivity, and/or intolerance to MOMA-313
  • Olaparib exposed patients with known hypersensitivity to PARP inhibitors (for patients considered for olaparib only)
  • Impaired GI function that may impact absorption.
  • Patient is pregnant or breastfeeding.
  • Known to be HIV positive, unless all of the following criteria are met:
  • Undetectable viral load or CD4+ count ≥300 cells/μL
  • Receiving highly active antiretroviral therapy
  • No AIDS-related illness within the past 12 months
  • Active liver disease (some exceptions are allowed)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 12 centers
  • Investigative Site #108 — Goodyear
  • Investigative Site #101 — La Jolla
  • Investigative Site #111 — San Francisco
  • Investigative Site #104 — Lake Mary
  • Investigative Site #110 — St Louis
  • Investigative Site #103 — New York
  • Investigative Site #106 — New York
  • Investigative Site #109 — Philadelphia
  • … and 4 more centers
Spain · 3 centers
  • Investigative Site #114 — Barcelona
  • Investigative Site #116 — Barcelona
  • Investigative Site #115 — Madrid
United Kingdom · 3 centers
  • Investigative Site #113 — London
  • Investigative Site #117 — Manchester
  • Investigative Site #118 — Newcastle upon Tyne

Identifiers

NCT: NCT06545942 · MOMA-313-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗