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

April 17, 2024 updated by: Nuvectis Pharma, Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

61

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Addenbrookes Hospital
      • Glasgow, United Kingdom, G12 0YN
    • Sutton Surrey
      • London Borough of Sutton, Sutton Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Honor Health
        • Contact:
          • Phone Number: 602-786-0795
    • California
      • La Jolla, California, United States, 92093
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Cancer Center
        • Contact:
          • Phone Number: 720-848-1060
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale Gynecologic Oncology
        • Contact:
          • Phone Number: 203-200-4176
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Comprehensive Cancer Center
        • Contact:
          • Phone Number: 305-674-2025
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Women's Cancer Care Associates
        • Contact:
          • Phone Number: 518-458-1390
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OU Health Stephenson Cancer Center
        • Contact:
          • Phone Number: 405-271-8777
      • Tulsa, Oklahoma, United States, 74146
        • Recruiting
        • Oklahoma Cancer Specialists and Research Institute
        • Contact:
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Oncology Associates of Oregon
        • Contact:
          • Phone Number: 541-683-5001
    • Pennsylvania
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Sidney Kimmel Cancer Center, Asplundh Cancer Pavilion
        • Contact:
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Texas Oncology
        • Contact:
          • Phone Number: 817-413-1760
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Health System
        • Contact:
          • Phone Number: 434-956-7840

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Dose Escalation
Escalating doses of NXP800.
Drug: NXP800
NXP800 is an anti-neoplastic, oral small molecule.
Experimental: Part B: Expansion in Ovarian Cancers Cohort 1
Subjects will be treated with NXP800 at 50 mg/day.
Drug: NXP800
NXP800 is an anti-neoplastic, oral small molecule.
Experimental: Part B: Expansion in Ovarian Cancers Cohort 2
Subjects will be treated with NXP800 at 75 mg/day.
Drug: NXP800
NXP800 is an anti-neoplastic, oral small molecule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part A: Number of patients with treatment related adverse events, clinical laboratory abnormalities, dose limiting toxicities
Time Frame: Day 28
Day 28
Part B: Estimates of disease response by RECIST v 1.1
Time Frame: Baseline to 30 days post last dose of NXP800
Baseline to 30 days post last dose of NXP800
Part B: Number of patients with treatment related adverse events, and/or clinical laboratory abnormalities.
Time Frame: Baseline to 30 days post last dose of NXP800
Baseline to 30 days post last dose of NXP800

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve (AUC) of NXP800
Time Frame: First dose through Day 29
First dose through Day 29
Maximum observed concentration (Cmax) of NXP800
Time Frame: First dose through Day 29
First dose through Day 29
Time to peak concentration (Tmax) of NXP800
Time Frame: First dose through Day 29
First dose through Day 29
Half-life (T1/2) of NXP800
Time Frame: First dose through Day 29
First dose through Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuvectis Pharma, Inc.

Collaborators

GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)

Investigators

  • Principal Investigator: Susana Banerjee, Dr, Institute of Cancer Research, Royal Marsden NHS Foundation Trust
  • Principal Investigator: Udai Banerji, Prof, Institute of Cancer Research, Royal Marsden Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NXP800-101
  • ENGOT-GYN5/NCRI/NXP800-101 (Other Identifier: ENGOT)
  • GOG-3087 (Other Identifier: GOG Foundation)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe