TerminatedPhase 1

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

Stopped: Study terminated due to various reasons impacting the feasibility of future clinical development

United States, United Kingdom45 participantsStarted 2021-12-31

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Part A 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 subje…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Day 28

Part B: Estimates of disease response by RECIST v 1.1

Timeframe: Baseline to 30 days post last dose of NXP800

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

Timeframe: Baseline to 30 days post last dose of NXP800

Trial details

NCT IDNCT05226507

SponsorNuvectis Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-01

View on ClinicalTrials.gov More Advanced Solid Tumor trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Day 28

Part B: Estimates of disease response by RECIST v 1.1

Timeframe: Baseline to 30 days post last dose of NXP800

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

Timeframe: Baseline to 30 days post last dose of NXP800