Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a pill target Hard-to-Treat ovarian cancers?

NCT ID NCT05226507

Disease control Sponsor: Nuvectis Pharma, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This early-stage trial is testing an experimental oral drug called NXP800 in people with advanced solid tumors that have not responded to standard treatments. The study has two parts: first, to find the safest dose and schedule, and then to see if the drug shows promise in specific ovarian cancers that carry an ARID1A gene mutation. The goal is to understand the drug's safety and whether it can shrink or control these tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NXP800, an oral small molecule drug
What this could lead to
If successful, NXP800 could become a new treatment option for advanced solid tumors, especially ovarian cancers with ARID1A mutations.
What could go wrong
This is an early-phase trial with a small number of participants, so the drug may not prove effective or safe. Side effects and dose-limiting toxicities are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

45 people

The number who actually took part.

Started

Dec 2021

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Part A Inclusion Criteria: * Provide written informed consent. * 18 years old or older. * Life expectancy of at least 12 weeks. * Histologically- or cytologically-confirmed, advanced, metastatic, and/or progressive solid tumors for whom there is no authorized or effective therapy available, or for whom such therapies are considered inappropriate by the Investigator (in Part B, subjects with specific cancer types will be enrolled; Specific criteria will be introduced in a protocol amendment). * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. Part A Exclusion Criteria: * Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first dose of NXP800. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer. * Ongoing toxic manifestations of previous treatments \> Grade 2. * Subjects with treated brain metastases are eligible if there is no evidence of progression for at least 28 days after central nervous system (CNS) directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \[MRI\] or computed tomography \[CT\] scan) during the Screening period. * Female subjects who can become pregnant (or are already pregnant or lactating). * Male subjects with partners of childbearing potential (unless they agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence). Part B Inclusion Criteria: * Provide written informed consent. * 18 years old or older. * Subjects with the following ARID1a mutated, ovarian/fallopian tube/primary peritoneal cancer histologies (ARID1a mutation status determined by a DNA-based Next Generation Sequencing test): * Clear cell ovarian carcinoma (≥ 50% clear cell carcinoma with no serous differentiation) * Endometrioid ovarian carcinoma * 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) * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. * Subjects with a BRCA mutation must have received prior treatment with a PARP inhibitor. * Subjects must have received at least 1 but not more than 3 prior systemic lines of anticancer therapy, including at least 1 line of therapy containing bevacizumab. * Adjuvant + neoadjuvant are considered one line of therapy * Maintenance therapy (i.e., bevacizumab, PARP inhibitors) will be considered as part of the preceeding line of therapy and are not counted independently. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Subjects must have a sufficient archival Formalin-Fixed Paraffin-Embedded (FFPE) tissue specimen, or be willing to consent to a fresh tissue biopsy during the study. Part B Exclusion Criteria: * Subjects with disease that did not respond to, or has progressed during or within 4 weeks of the last dose of first-line platinum containing chemotherapy. * Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first dose of NXP800. * Ongoing toxic manifestations of previous treatments \> Grade 2, with the exception of alopecia. * Subjects with treated brain metastases are eligible if there is no evidence of progression for at least 12 weeks while off corticosteroids after central nervous system (CNS) directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \[MRI\] or computed tomography \[CT\] scan) during the Screening period. * Female subjects who can become pregnant (or are already pregnant or lactating).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

adenocarcinoma carcinoma neoplasm ovarian cancer ovarian clear cell adenocarcinoma ovarian clear cell cancer ovarian clear cell tumor ovarian endometrial cancer ovarian endometrioid adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor ARID1A gene mutation Ovarian cancer Ovarian clear cell adenocarcinoma Ovarian clear cell carcinoma Ovarian clear cell tumor Ovarian endometrioid adenocarcinoma Ovarian endometrioid tumor

Contacts and locations

Locations

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Florida Cancer Specialists Research East

    West Palm Beach, Florida, 33401, United States

  • Florida Cancer Specialists Research North

    St. Petersburg, Florida, 33705, United States

  • Florida Cancer Specialists South

    Fort Myers, Florida, 33901, United States

  • Honor Health

    Phoenix, Arizona, 85016, United States

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140, United States

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma, 74146, United States

  • Oncology Associates of Oregon

    Eugene, Oregon, 97401, United States

  • Royal Marsden Hospital

    Sutton, Sutton Surrey, SM2 5PT, United Kingdom

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • Sidney Kimmel Cancer Center, Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19090, United States

  • Texas Oncology

    Fort Worth, Texas, 76104, United States

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UC San Diego Health - Moores Cancer Center

    La Jolla, California, 92093, United States

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • Women's Cancer Care Associates

    Albany, New York, 12208, United States

  • Yale Gynecologic Oncology

    New Haven, Connecticut, 06511, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.