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Testing NXP800 in patients with advanced cancers and ovarian cancer

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

Phase 1 Interventional Nuvectis Pharma, Inc. · NCT05226507

This study is testing a new drug called NXP800 to see if it can help people with advanced ovarian cancer and other solid tumors that have specific genetic changes.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment61 (estimated)
Ages18 Years and up
SexAll
SponsorNuvectis Pharma, Inc. Industry-sponsored
Drugs / interventionsbevacizumab, chemotherapy
Locations23 sites (Phoenix, Arizona and 22 other locations)
Trial IDNCT05226507 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of NXP800 in patients with advanced solid tumors, focusing on those with ARID1a mutations in ovarian clear cell and endometrioid cancers. The study consists of two parts: a dose escalation phase to determine the maximum tolerated dose (MTD) of NXP800, followed by an expansion phase that assesses the preliminary efficacy of the drug in a specific patient population. Participants must have advanced cancers for which no effective therapies are available. The trial aims to provide insights into the potential of NXP800 as a treatment option for these patients.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced, metastatic solid tumors who have ARID1a mutations and for whom no effective therapies are available.

Not a fit: Patients with early-stage cancers or those who have received recent treatments that may interfere with the study will not benefit from this trial.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option for patients with advanced ovarian cancer and other solid tumors.

How similar studies have performed: Other studies targeting ARID1a mutations have shown promise, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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 Inclusion Criteria:

* 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.

Part B Exclusion Criteria:

* 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).

Where this trial is running

Phoenix, Arizona and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid TumorOvarian CancerOvarian Clear Cell CarcinomaOvarian Clear Cell TumorOvarian Clear Cell AdenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Endometrioid TumorARID1A Gene Mutation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.