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A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer
Trial Status: closed to accrual
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.
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. Part A
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 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). Part B
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05226507.
Locations matching your search criteria
United States
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Active
Name Not Available
Oklahoma
Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available
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,
