Trials / Active Not Recruiting
Active Not RecruitingNCT05226507
A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Nuvectis Pharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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, ARID1a-mutated ovarian carcinoma.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NXP800 | NXP800 is an anti-neoplastic, oral small molecule. |
Timeline
- Start date
- 2021-12-31
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2022-02-07
- Last updated
- 2025-08-08
Locations
22 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05226507. Inclusion in this directory is not an endorsement.