ACTIVE_NOT_RECRUITING

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

Conditions

Advanced Solid Tumor Ovarian Cancer Ovarian Clear Cell Carcinoma Ovarian Clear Cell Tumor Ovarian Clear Cell Adenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Endometrioid Tumor ARID1A Gene Mutation Solid Tumor Carcinoma Neoplasms Adenocarcinoma ARID1a

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-12-31

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05226507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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).

Inclusion Criteria

Exclusion 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.

* 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).

Contacts and Locations

Principal Investigator

Udai Banerji, Prof

PRINCIPAL_INVESTIGATOR

Institute of Cancer Research, Royal Marsden Foundation Trust

Susana Banerjee, Dr

PRINCIPAL_INVESTIGATOR

Institute of Cancer Research, Royal Marsden NHS Foundation Trust

Study Locations (Sites)

Honor Health

Phoenix, Arizona, 85016

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

Yale Gynecologic Oncology

New Haven, Connecticut, 06511

United States

Florida Cancer Specialists South

Fort Myers, Florida, 33901

United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140

United States

Florida Cancer Specialists Research North

Saint Petersburg, Florida, 33705

United States

Florida Cancer Specialists Research East

West Palm Beach, Florida, 33401

United States

University of Iowa

Iowa City, Iowa, 52242

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

United States

Women's Cancer Care Associates

Albany, New York, 12208

United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

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

Sidney Kimmel Cancer Center, Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090

United States

Texas Oncology

Fort Worth, Texas, 76104

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

University of Virginia Health System

Charlottesville, Virginia, 22908

United States

Collaborators and Investigators

Sponsor: Nuvectis Pharma, Inc.

Udai Banerji, Prof, PRINCIPAL_INVESTIGATOR, Institute of Cancer Research, Royal Marsden Foundation Trust
Susana Banerjee, Dr, PRINCIPAL_INVESTIGATOR, Institute of Cancer Research, Royal Marsden NHS Foundation Trust

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-31

Study Completion Date2025-12

Study Record Updates

Study Start Date2021-12-31

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Solid Tumor
Carcinoma
Neoplasms
Adenocarcinoma
ARID1a

Additional Relevant MeSH Terms

Advanced Solid Tumor
Ovarian Cancer
Ovarian Clear Cell Carcinoma
Ovarian Clear Cell Tumor
Ovarian Clear Cell Adenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Endometrioid Tumor
ARID1A Gene Mutation