A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer
NCT ID: NCT05226507
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
45 participants
INTERVENTIONAL
2021-12-31
2025-12-31
Brief Summary
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Detailed Description
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In Part B doses selected in Part A are administered to patients with platinum-resistant, ARID1a-mutated ovarian carcinoma.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: Dose Escalation
Escalating doses of NXP800 administered orally once or twice daily.
NXP800
NXP800 is an anti-neoplastic, oral small molecule.
Part B: Expansion in Ovarian Cancers Cohort 1
Subjects will be treated with NXP800 at 50 mg/day orally.
NXP800
NXP800 is an anti-neoplastic, oral small molecule.
Part B: Expansion in Ovarian Cancers Cohort 2
Subjects will be treated with NXP800 at 75 mg/day orally.
NXP800
NXP800 is an anti-neoplastic, oral small molecule.
Interventions
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NXP800
NXP800 is an anti-neoplastic, oral small molecule.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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).
* 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).
18 Years
ALL
No
Sponsors
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Gynecologic Oncology Group Foundation
UNKNOWN
The European Network for Gynaecological Oncological Trial groups (ENGOT)
UNKNOWN
Nuvectis Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Udai Banerji, Prof
Role: PRINCIPAL_INVESTIGATOR
Institute of Cancer Research, Royal Marsden Foundation Trust
Susana Banerjee, Dr
Role: PRINCIPAL_INVESTIGATOR
Institute of Cancer Research, Royal Marsden NHS Foundation Trust
Locations
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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
Women's Cancer Care Associates
Albany, New York, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, United States
Oncology Associates of Oregon
Eugene, Oregon, United States
Sidney Kimmel Cancer Center, Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States
Texas Oncology
Fort Worth, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Royal Marsden Hospital
Sutton, Sutton Surrey, United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Countries
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Other Identifiers
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ENGOT-GYN5/GTG-UK/NXP800-101
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-3087
Identifier Type: OTHER
Identifier Source: secondary_id
NXP800-101
Identifier Type: -
Identifier Source: org_study_id
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