What is the mechanism of action of this treatment?

The most common treatments for solid tumors include targeted therapies and chemotherapy. Targeted therapies, such as those being studied in the NXP800 trial for ARID1a mutated ovarian cancers, work by specifically attacking cancer cells with certain genetic mutations, thereby sparing normal cells and reducing side effects. Chemotherapy, in contrast, kills rapidly dividing cells indiscriminately, affecting both cancerous and healthy cells, which can lead to broader side effects. Understanding these mechanisms helps patients and doctors make informed decisions about treatment options, balancing efficacy and potential side effects based on the patient's specific cancer profile.

What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly those targeting ARID1a mutations in ovarian cancers, include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy often causes side effects such as nausea, vomiting, hair loss, and fatigue. Targeted therapies, like PARP inhibitors, can lead to anemia, thrombocytopenia, and neutropenia. Immunotherapies, such as PD-1/PD-L1 inhibitors, may cause immune-related adverse events including colitis, dermatitis, and pneumonitis. These treatments aim to improve efficacy while managing the associated toxicities.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of solid tumors, particularly those with specific genetic mutations. For instance, PARP inhibitors such as olaparib and niraparib have been approved for BRCA-mutated ovarian cancers. Additionally, immune checkpoint inhibitors like pembrolizumab and nivolumab have been approved for tumors with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). While specific FDA approvals for ARID1a-targeting drugs in ovarian cancer are not mentioned, the ongoing study of NXP800 aims to address this gap by evaluating its efficacy in ARID1a mutated ovarian cancers.

What other types of research exist?

Promising novel alternatives to NXP800 for solid tumor patients, particularly those with ARID1a mutations in ovarian cancers, include: 1) PARP inhibitors like olaparib and niraparib, which have shown efficacy in BRCA-mutated cancers and are being explored for other genetic contexts. 2) Immune checkpoint inhibitors such as pembrolizumab and nivolumab, which are being tested in various solid tumors, including ovarian cancer. 3) Targeted therapies like bevacizumab, an anti-angiogenic agent, which has been used in combination with chemotherapy for ovarian cancer. 4) Investigational IDH inhibitors like ivosidenib and vorasidenib, which are in trials for IDH-mutant gliomas and may have potential in other solid tumors with similar mutations.

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NXP800 for Advanced Cancers

Phase 1

Recruiting

Led By Susana Banerjee, Dr

Research Sponsored by Nuvectis Pharma, Inc.

Eligibility Criteria Checklist

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

Must have

Part B: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Part B: Subjects must have disease progression within 6 months (182 days) from completion of platinum-based therapy (6 months should be calculated from the date of the last administered dose of platinum therapy to the date of radiographic imaging showing progression)

Must not have

Part A: Female subjects who can become pregnant (or are already pregnant or lactating)

Part A: Ongoing toxic manifestations of previous treatments > Grade 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests NXP800, a new drug, for safety and effectiveness in patients with advanced cancers, especially those with ARID1a-mutated ovarian carcinoma who haven't responded to other treatments. The goal is to find the safest dose and see if it can help control or reduce the cancer.

Who is the study for?

Adults with advanced solid tumors without effective treatment options, or those inappropriate as per the investigator. Specifically for Part B: adults with ARID1a mutated ovarian cancers who've had certain prior treatments and have measurable disease progression. Excludes pregnant/lactating women, men unwilling to prevent pregnancy, and those with recent other treatments or ongoing severe side effects.

What is being tested?

NXP800 is being tested for safety at different doses/schedules in advanced cancer patients (Part A), and its preliminary efficacy in specific ovarian cancers with ARID1a mutation (Part B). The trial has two phases: dose escalation to assess safety and an expansion phase focusing on efficacy.

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical reactions to new cancer drugs such as nausea, fatigue, allergic responses, blood count changes, organ inflammation or dysfunction based on similar trials. Specific side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer worsened within 6 months after finishing platinum-based treatment.

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My ovarian cancer has an ARID1a mutation and is either clear cell or endometrioid type.

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I can take care of myself but might not be able to do heavy physical work.

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I can provide a tissue sample for the study, either already collected or by undergoing a biopsy.

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I am 18 years old or older.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman who could become pregnant, or am currently pregnant or breastfeeding.

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I have severe side effects from past treatments.

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I am a woman who could become pregnant, am pregnant, or am breastfeeding.

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My cancer did not improve or got worse after first-line platinum chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part B: Expansion in Ovarian Cancers Cohort 2Experimental Treatment1 Intervention

Subjects will be treated with NXP800 at 75 mg/day orally.

Group II: Part B: Expansion in Ovarian Cancers Cohort 1Experimental Treatment1 Intervention

Subjects will be treated with NXP800 at 50 mg/day orally.

Group III: Part A: Dose EscalationExperimental Treatment1 Intervention

Escalating doses of NXP800 administered orally once or twice daily.

0 / 11Eligibility criteria met

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 targeted therapies and chemotherapy. Targeted therapies, such as those being studied in the NXP800 trial for ARID1a mutated ovarian cancers, work by specifically attacking cancer cells with certain genetic mutations, thereby sparing normal cells and reducing side effects. Chemotherapy, in contrast, kills rapidly dividing cells indiscriminately, affecting both cancerous and healthy cells, which can lead to broader side effects. Understanding these mechanisms helps patients and doctors make informed decisions about treatment options, balancing efficacy and potential side effects based on the patient's specific cancer profile.