What side effects are associated with this type of intervention?

PARP inhibitors, like NMS-03305293, commonly cause side effects such as anemia, fatigue, nausea, and decreased blood cell counts (neutropenia and thrombocytopenia). Other treatments for solid tumors, such as chemotherapy, can lead to side effects including hair loss, gastrointestinal issues (nausea, vomiting, diarrhea), and increased risk of infections due to lowered white blood cell counts. Immunotherapy, including immune checkpoint inhibitors, may cause immune-related adverse events like pneumonitis, colitis, hepatitis, and endocrinopathies. These treatments can also lead to fatigue, skin rashes, and, less commonly, severe inflammatory responses.

What prior FDA approvals exist?

PARP inhibitors have been approved by the FDA for the treatment of various solid tumors, particularly those with specific genetic mutations. For instance, olaparib and rucaparib have been approved for use in metastatic castration-resistant prostate cancer (CRPC) with homologous recombination repair (HRR) gene mutations, including BRCA1/2. Niraparib has also shown efficacy in prostate cancer patients with BRCA1 or BRCA2 mutations. These approvals highlight the role of PARP inhibitors in targeting tumors with specific genetic vulnerabilities, similar to the investigational drug NMS-03305293 being studied for advanced/metastatic solid tumors.

What other types of research exist?

Promising alternatives to NMS-03305293 for solid tumors include: 1) Pembrolizumab, a PD-1 inhibitor, for tumors with high TMB or dMMR. 2) Olaparib, another PARP inhibitor, especially effective in patients with HRR gene alterations. 3) Niraparib, shown to improve outcomes in patients with BRCA1/2 alterations. 4) Combination therapies like Olaparib with abiraterone for enhanced efficacy in metastatic castration-resistant prostate cancer.

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PARP Inhibitor

NMS-03305293 for Solid Tumors

Phase 1

Waitlist Available

Led By PierFranco Conte, MD

Research Sponsored by Nerviano Medical Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of first dose of study drug up to the date of first documentation of disease progression or death due to progression, an average of 2 years.

Awards & highlights

Summary

This trial tests a new drug called NMS-03305293, which blocks a protein that helps cancer cells repair themselves. It is aimed at adults with advanced or resistant cancers who have no other treatment options. The drug works by stopping cancer cells from fixing their DNA, which can help to kill them.

Who is the study for?

Adults with certain advanced or metastatic solid tumors who have tried all standard treatments or can't receive them. They must be able to swallow capsules, have a life expectancy of at least 3 months, and an ECOG performance status ≤2. Participants need measurable disease by RECIST criteria, except for CRPC patients who may have non-measurable disease.

What is being tested?

The trial is testing NMS-03305293 (a PARP inhibitor) as a single agent in phase I to see how safe it is and if it works against specific relapsed/refractory solid tumors. It's the first time this drug is being given to humans, starting with low doses that increase until they find the best dose without severe side effects.

What are the potential side effects?

As this is a first-in-human study for NMS-03305293, potential side effects are not yet fully known but may include typical reactions seen with other PARP inhibitors such as nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first dose of study drug up to the date of first documentation of disease progression or death due to progression, an average of 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first dose of study drug up to the date of first documentation of disease progression or death due to progression, an average of 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first dose of study drug up to the date of first documentation of disease progression or death due to progression, an average of 2 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Accumulation ratio (Rac) of NMS-033052293 after multiple doses of drug.

Apparent volume of distribution (Vd/F) of NMS-033052293 after multiple doses of drug.

Area under the concentration-time curve to the last of measurable concentration (AUClast) of NMS-033052293 after single and repeated dose of drug.

+11 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Dose Expansion Part - Pretreated HER 2 Neg. Breast CancerExperimental Treatment1 Intervention

Patients with gBRCA mutation and HER2 negative breast cancer previously treated with a PARP inhibitor.

Group II: Dose Expansion Part - Pancreatic CancerExperimental Treatment1 Intervention

Patients with gBRCA mutation and pancreatic cancer who have not received prior therapy with a PARP inhibitor.

Group III: Dose Expansion Part - No Pretreated HER 2 Neg. Breast CancerExperimental Treatment1 Intervention

Patients with gBRCA mutation and HER2 negative breast cancer who have not received prior therapy with a PARP inhibitor.

Group IV: Dose Expansion Part - Epithelial Ovarian CancerExperimental Treatment1 Intervention

Patients with gBRCA mutation and epithelial ovarian cancer.

Group V: Dose Expansion Part - CRPCExperimental Treatment1 Intervention

Patients with gBRCA mutation and castration-resistant prostate cancer (CRPC).

Group VI: Dose Escalation PartExperimental Treatment1 Intervention

Patients with histologically confirmed diagnosis of locally advanced/metastatic HER2 negative breast cancer, epithelial ovarian cancer, castration-resistant prostate cancer (CRPC) or pancreatic cancer.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for solid tumors include chemotherapy, immunotherapy, targeted therapy, and PARP inhibitors. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects healthy cells, leading to side effects. Immunotherapy boosts the body's immune system to recognize and attack cancer cells, offering a more targeted approach with potentially fewer side effects. Targeted therapy involves drugs designed to target specific genetic mutations or proteins that are involved in cancer growth and survival. PARP inhibitors, like the one studied in the trial NMS-03305293, block the PARP enzyme, which helps repair DNA damage in cells. By inhibiting PARP, these drugs prevent cancer cells from repairing their DNA, leading to cell death, particularly in tumors with existing DNA repair deficiencies such as BRCA mutations. This is crucial for solid tumor patients as it offers a more precise treatment option that can potentially improve outcomes and reduce side effects compared to traditional chemotherapy.

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Who is running the clinical trial?

Nerviano Medical SciencesLead Sponsor

13 Previous Clinical Trials

914 Total Patients Enrolled

PierFranco Conte, MDPrincipal InvestigatorIstituto Oncologico Veneto IRCCS

1 Previous Clinical Trials

524 Total Patients Enrolled

Valentina Guarneri, MDPrincipal InvestigatorIstituto Oncologico Veneto IRCCS

Media Library

NMS-03305293 (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04182516 — Phase 1

Solid Tumors Research Study Groups: Dose Expansion Part - CRPC, Dose Expansion Part - Pancreatic Cancer, Dose Expansion Part - Epithelial Ovarian Cancer, Dose Expansion Part - Pretreated HER 2 Neg. Breast Cancer, Dose Escalation Part, Dose Expansion Part - No Pretreated HER 2 Neg. Breast Cancer

Solid Tumors Clinical Trial 2023: NMS-03305293 Highlights & Side Effects. Trial Name: NCT04182516 — Phase 1

NMS-03305293 (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04182516 — Phase 1

~26 spots leftby Sep 2025

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