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

NCT05226507 | Active Not Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: NXP800-101ENGOT-GYN5/GTG-UK/NXP800-101GOG-3087
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 22

Brief 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.

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

Keywords

Solid Tumor; Carcinoma; Neoplasms; Adenocarcinoma; ARID1a

Outcome Measures

Primary Outcomes (3)

• Part A: Number of patients with treatment related adverse events, clinical laboratory abnormalities, dose limiting toxicities

  Day 28

• Part B: Estimates of disease response by RECIST v 1.1

  Baseline to 30 days post last dose of NXP800

• Part B: Number of patients with treatment related adverse events, and/or clinical laboratory abnormalities.

  Baseline to 30 days post last dose of NXP800

Secondary Outcomes (4)

• Area under the concentration-time curve (AUC) of NXP800

  First dose through Day 29

• Maximum observed concentration (Cmax) of NXP800

  First dose through Day 29

• Time to peak concentration (Tmax) of NXP800

  First dose through Day 29

• Half-life (T1/2) of NXP800

  First dose through Day 29

Study Arms (3)

Part A: Dose Escalation

EXPERIMENTAL

Escalating doses of NXP800 administered orally once or twice daily.

Drug: NXP800

Part B: Expansion in Ovarian Cancers Cohort 1

EXPERIMENTAL

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

Drug: NXP800

Part B: Expansion in Ovarian Cancers Cohort 2

EXPERIMENTAL

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

Drug: NXP800

Interventions

NXP800 DRUG

NXP800 is an anti-neoplastic, oral small molecule.

Part A: Dose Escalation; Part B: Expansion in Ovarian Cancers Cohort 1; Part B: Expansion in Ovarian Cancers Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Part B is enrolling ovarian cancer patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent.
• 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.

You may not qualify if:

• 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).
• Provide written informed consent.
• 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

Sponsors & Collaborators

• Nuvectis Pharma, Inc.: lead
• Gynecologic Oncology Group Foundation: collaborator
• The European Network for Gynaecological Oncological Trial groups (ENGOT): collaborator

Study Sites (22)

Honor Health

Phoenix, Arizona, 85016, United States

Location

UC San Diego Health - Moores Cancer Center

La Jolla, California, 92093, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Yale Gynecologic Oncology

New Haven, Connecticut, 06511, United States

Location

Florida Cancer Specialists South

Fort Myers, Florida, 33901, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

Florida Cancer Specialists Research North

St. Petersburg, Florida, 33705, United States

Location

Florida Cancer Specialists Research East

West Palm Beach, Florida, 33401, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Women's Cancer Care Associates

Albany, New York, 12208, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, 74146, United States

Location

Oncology Associates of Oregon

Eugene, Oregon, 97401, United States

Location

Sidney Kimmel Cancer Center, Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090, United States

Location

Texas Oncology

Fort Worth, Texas, 76104, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Royal Marsden Hospital

Sutton, Sutton Surrey, SM2 5PT, United Kingdom

Location

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma; Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Udai Banerji, Prof

  Institute of Cancer Research, Royal Marsden Foundation Trust

  PRINCIPAL INVESTIGATOR

• Susana Banerjee, Dr

  Institute of Cancer Research, Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A dose escalation followed by Part B, expansion in ovarian cancers.

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 7, 2022
• Study Start: December 31, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

US (19); GB (3)