MOMA-313 + Olaparib for Solid Tumors
Recruiting in Palo Alto (17 mi)
+15 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: MOMA Therapeutics
Must be taking: PARP inhibitors
Must not be taking: Polymerase theta inhibitors
Disqualifiers: Cardiovascular disease, CNS metastasis, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you must be fully recovered from the effects of prior therapy, and hormonal therapy is allowed. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Olaparib in treating solid tumors?
Olaparib, a drug used for certain types of breast and ovarian cancer, has shown effectiveness in patients with specific genetic mutations that affect DNA repair. It is particularly beneficial for those with BRCA mutations, and research suggests it may also help patients with other DNA repair issues.
12345What safety data exists for Olaparib (Lynparza) in humans?
Olaparib (Lynparza) has been studied for safety in various trials, including in Japanese and Chinese patients with advanced solid tumors, and in patients with breast or ovarian cancer. These studies generally show that Olaparib can be administered safely, though like many medications, it may have side effects.
13678What makes the drug MOMA-313 + Olaparib unique for treating solid tumors?
The combination of MOMA-313 with Olaparib is unique because Olaparib is a PARP inhibitor that has shown effectiveness in treating cancers with specific genetic mutations, like BRCA mutations, by targeting cancer cells' DNA repair mechanisms. This combination may offer a novel approach for solid tumors, potentially enhancing the effectiveness of treatment by combining different mechanisms of action.
12349Eligibility Criteria
This trial is for adults with advanced or metastatic solid tumors, such as pancreatic, prostate, ovarian, and breast cancers. Participants must have a deficiency in homologous recombination repair mechanisms within their tumor cells.Inclusion Criteria
Histologically confirmed disease for each treatment arm as follows:
My organs are working well according to recent tests.
Written informed consent obtained according to local guidelines
+9 more
Exclusion Criteria
I have been treated with a polymerase theta inhibitor before.
Undetectable viral load or CD4+ count ≥300 cells/μL
I don't have any health issues that could risk my safety or affect the study results.
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive MOMA-313 as a single agent or in combination with olaparib in dose-escalation and dose-optimization phases
21-28 day cycles
Multiple visits per cycle
Follow-up
Participants are monitored for safety, tolerability, and clinical activity after treatment
Up to 35 months
Participant Groups
The study tests the safety and effects of MOMA-313 taken by mouth alone or combined with Olaparib. It's an early-phase trial to find the right dose and see how these drugs affect participants' bodies (PK/PDx) and their cancer.
2Treatment groups
Experimental Treatment
Group I: MOMA-313 in Combination with Olaparib (Treatment Arm 2)Experimental Treatment2 Interventions
MOMA-313 administered together with twice daily (BID) olaparib in 28-day cycles.
Group II: MOMA-313 Monotherapy (Treatment Arm 1)Experimental Treatment1 Intervention
MOMA-313 administered as a single-agent in 21-day cycles.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Investigative SiteSan Antonio, TX
Investigative SiteFairfax, VA
Investigative SiteMyrtle Beach, SC
Investigative SiteSaint Louis, MO
More Trial Locations
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Who Is Running the Clinical Trial?
MOMA TherapeuticsLead Sponsor
References
New Adjuvant Treatment for High-Risk Early Breast Cancer. [2022]Olaparib (Lynparza) is now approved for the adjuvant treatment of adult patients who have, or are suspected to have, the germline variation of BRCA-mutated human epidermal growth factor receptor 2-negative high-risk early breast cancer and who were previously treated with neoadjuvant or adjuvant chemotherapy.
Candidate biomarkers of PARP inhibitor sensitivity in ovarian cancer beyond the BRCA genes. [2020]Olaparib (Lynparza™) is a PARP inhibitor approved for advanced BRCA-mutated (BRCAm) ovarian cancer. PARP inhibitors may benefit patients whose tumours are dysfunctional in DNA repair mechanisms unrelated to BRCA1/2. We report exploratory analyses, including the long-term outcome of candidate biomarkers of sensitivity to olaparib in BRCA wild-type (BRCAwt) tumours.
Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. [2022]The PARP inhibitor olaparib (Lynparza™) demonstrates antitumor activity in women with relapsed ovarian cancer and a germline BRCA1/2 mutation (gBRCAm). Data from olaparib monotherapy trials were used to explore the treatment effect of olaparib in patients with gBRCAm ovarian cancer who had received multiple lines of prior chemotherapy.
Olaparib: an oral PARP-1 and PARP-2 inhibitor with promising activity in ovarian cancer. [2016]Olaparib (Lynparza™; AZD2281) is a potent PARP-1 and PARP-2 inhibitor with biologic activity in ovarian cancer as well as other solid tumors. It has been tested in Phase I and II trials and has single-agent activity in both germline BRCA mutated and sporadic ovarian cancer. Phase III trials assessing the efficacy of olaparib in the maintenance setting following first line and platinum-sensitive recurrence are underway for patients with a germline BRCA mutation, given the inherent molecular compatibility with the drug's mechanism of action.
Safety evaluation of olaparib for treating ovarian cancer. [2015]Olaparib (Lynparza®) is an oral, small molecule, poly (ADP-ribose) polymerase inhibitor that has become the first 'personalized' therapy available for patients with BRCA mutation-positive ovarian cancer (OC). A capsule formulation of the drug has recently received approval for use in this population for platinum-sensitive recurrent disease for maintenance therapy following platinum-based chemotherapy in Europe and as third- or fourth-line platinum-sensitive therapy in the USA.
Phase I/Ib study of olaparib and carboplatin in BRCA1 or BRCA2 mutation-associated breast or ovarian cancer with biomarker analyses. [2022]Olaparib has single-agent activity against breast/ovarian cancer (BrCa/OvCa) in germline BRCA1 or BRCA2 mutation carriers (gBRCAm). We hypothesized addition of olaparib to carboplatin can be administered safely and yield preliminary clinical activity.
Safety and tolerability of the olaparib tablet formulation in Japanese patients with advanced solid tumours. [2022]This was the first Phase I study to assess the safety and tolerability of the tablet formulation of olaparib (Lynparza™), an oral poly(ADP-ribose) polymerase inhibitor, in Japanese patients with advanced solid tumours. The pharmacokinetic profile and antitumour activity of olaparib tablets were also assessed.
Pharmacokinetics and safety of olaparib tablets as monotherapy and in combination with paclitaxel: results of a Phase I study in Chinese patients with advanced solid tumours. [2020]Chinese patients have been enrolled in multiple Phase III trials of the poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza); however, the pharmacokinetic (PK) profile of olaparib has not been investigated in this population. This two-part, open-label Phase I study was, therefore, carried out to determine the PK and safety profile of olaparib (tablet formulation) in Chinese patients with advanced solid tumours as monotherapy and in combination with paclitaxel (NCT02430311).
Olaparib: a review of its use as maintenance therapy in patients with ovarian cancer. [2016]Olaparib (Lynparza™) is a first-in-class, orally-active, small molecule, poly (ADP-ribose) polymerase inhibitor that induces synthetic lethality in homozygous BRCA-deficient cells. In the EU, the capsule formulation of olaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive, relapsed, BRCA-mutated (germline and/or somatic), high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. This approval was based on the results of study 19, a randomized phase II trial in 265 patients with platinum-sensitive, relapsed, high-grade serous ovarian cancer (HGSOC) who had received two or more platinum-based regimens and who had a partial or complete response to their most recent platinum-based regimen. Study 19 met its primary endpoint by demonstrating a significant improvement in progression-free survival in patients receiving olaparib compared with those receiving placebo. Moreover, a preplanned retrospective analysis identified those patients with a BRCA mutation (who comprised one-half of the overall study population) as being the subgroup that derived the greatest clinical benefit from olaparib. Single-agent olaparib was generally well tolerated, with the majority of adverse events being of mild to moderate severity and not requiring interruption of treatment. Fatigue, anaemia and neutropenia were the most frequently reported severe (grade ≥3) adverse events. An as yet unapproved tablet formulation of olaparib that has a lower pill burden than the capsule formulation is currently being investigated in phase III clinical studies.