A Phase 1 Clinical Study of NXP800 in Subjects with Advanced Cancers and Expansion in Subjects with Ovarian 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.

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Phoenix

Honor Health, Phoenix, Arizona, United States, 85016

La Jolla

UC San Diego Health - Moores Cancer Center, La Jolla, California, United States, 92093

Aurora

University of Colorado Cancer Center, Aurora, Colorado, United States, 80045

New Haven

Yale Gynecologic Oncology, New Haven, Connecticut, United States, 06511

Fort Myers

Florida Cancer Specialists South, Fort Myers, Florida, United States, 33901

Miami Beach

Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States, 33140

St. Petersburg

Florida Cancer Specialists Research North, St. Petersburg, Florida, United States, 33705

West Palm Beach

Florida Cancer Specialists Research East, West Palm Beach, Florida, United States, 33401

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

New Brunswick

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States, 08901

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2025-12