Study launches of MOMA-313 in solid tumors, including prostate cancer

The first patient has been dosed in a phase 1 clinical trial (NCT06545942) exploring the oral polymerase theta helicase inhibitor MOMA-313 for patients with solid tumors, including metastatic prostate cancer, that harbor alterations in certain DNA repair genes, MOMA Therapeutics announced in a news release.¹

Completion of the trial is anticipated for November 2027.

Overall, the phase 1 trial is assessing the safety and tolerability of MOMA-313 as both a monotherapy and in combination with the PARP inhibitor olaparib (Lynparza) in patients with subgroups of prostate cancer, pancreatic cancer, and breast cancer.

In addition to the trial of MOMA-313, the company is also continuing the development of their second lead candidate, MOMA-341, a covalent Werner helicase inhibitor for the treatment of patients with cancers with microsatellite instability, including colorectal, gastric, and endometrial cancers. MOMA-341 will be explored as both a monotherapy and in combination with chemotherapy and immunotherapy.

“We are excited to be progressing 2 molecules with best-in-class potential toward the benefit of cancer patients in need in such close proximity,” said MOMA Therapeutics CEO Asit Parikh, MD, PhD, in the news release.¹ “The advance into clinical development for a company founded as an idea on paper a few years back is humbling. This progress serves as a testament to the excellence and unwavering commitment of the entire MOMA team.”

In total, the phase 1 multicenter, open-label, dose escalation and dose optimization trial of MOMA-313 plans to enroll 158 adult patients with HR-deficient advanced or metastatic solid tumors.²

Patients are eligible for the study if they have histologically confirmed disease, at least 1 lesion at baseline, an ECOG performance score of 2 or lower, and adequate organ function. Additionally, patients must have fully recovered from clinically relevant effects of prior therapy, radiotherapy, and/or surgery.

In the monotherapy arm, histologically confirmed disease includes patients with advanced or metastatic tumors that are not eligible for curative therapy and have been exposed to a prior PARP inhibitor. In the dose escalation combination cohorts, patients must have advanced or metastatic tumors with select HR-deficient mutations that are not eligible for curative therapy. Patients may be PARP inhibitor naïve or exposed. In the dose optimization combination cohorts, patients must have metastatic prostate cancer, pancreatic cancer, or breast cancer with select HR-deficient mutations, and they must be PARP inhibitor naïve.

The study will first advance through the dose escalation phase of the trial, in which cohorts of patients will receive increasing oral doses of MOMA-313 as a monotherapy or in combination with olaparib. In the monotherapy cohorts, MOMA-313 will be a delivered orally as a single agent in 21-day cycles. In the combination cohorts, patients will receive oral MOMA-313 with twice-daily olaparib in 28-day cycles.

The primary outcome measures for the trial are safety and tolerability, measured by the number of participants with adverse events (AEs), dose-limiting toxicities, serious AEs, and AEs leading to treatment discontinuation. Secondary outcome measures include identifying the recommended phase 2 dose level, several pharmacokinetic parameters, and initial efficacy measures. These efficacy measures include objective response rate, duration of response, time to response, progression-free survival, disease control rate, and overall survival, all assessed for up to 35 months.

Final completion of the trial is anticipated for November 2027.

References

1. MOMA Therapeutics announces initiation of phase 1 clinical trial for MOMA-313, a novel polymerase theta helicase inhibitor. News release. MOMA Therapeutics. Published online and accessed August 19, 2024. https://momatx.com/posts/moma-therapeutics-announces-initiation-of-phase-1-clinical-trial-for-moma-313/

2. Study of orally administered MOMA-313 in participants with advanced or metastatic solid tumors. ClinicalTrials.gov. Last updated August 12, 2024. Accessed August 19, 2024. https://clinicaltrials.gov/study/NCT06545942