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A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer

NCT05226507•Nuvectis Pharma, Inc.

View on ClinicalTrials.gov

Summary

The purpose of the dose escalation phase is to evaluate the safety profile of escalating doses and dose schedules of NXP800. In the expansion phase the preliminary efficacy in subjects with ARID1a mutated ovarian clear cell and ovarian endometrioid cancers will be estimated.

Detailed Description

Part A of the study is a dose escalation by cohort study of NXP800 administered to patients with advanced cancers. The study will identify the maximum tolerated dose (MTD) and propose dose and dose schedules for future studies. In Part B doses selected in Part A are administered to patients with platinum-resistant, ARID1a-mutated ovarian carcinoma.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
•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).
•Provide written informed consent.
•18 years old or older.
+12 more criteria

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 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.

Locations (22)

Honor Health

Phoenix, Arizona, United States

UC San Diego Health - Moores Cancer Center

La Jolla, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Yale Gynecologic Oncology

New Haven, Connecticut, United States

Florida Cancer Specialists South

Fort Myers, Florida, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Florida Cancer Specialists Research North

St. Petersburg, Florida, United States

Florida Cancer Specialists Research East

West Palm Beach, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Key Dates

Start Date

December 31, 2021

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

August 8, 2025

Enrollment

ACTUAL participants

Conditions

Advanced Solid TumorOvarian CancerOvarian Clear Cell CarcinomaOvarian Clear Cell TumorOvarian Clear Cell AdenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Endometrioid TumorARID1A Gene Mutation

Interventions

NXP800

DRUG

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

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IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

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