A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers

• ClinicalTrials.gov Identifier: NCT05873686
• Recruitment Status: Recruiting
• First Posted: May 24, 2023
• Last Update Posted: May 14, 2024
• Sponsor: Nuvectis Pharma, Inc.
• Information provided by (Responsible Party): Nuvectis Pharma, Inc.

Tracking Information

• First Submitted Date: May 15, 2023
• First Posted Date: May 24, 2023
• Last Update Posted Date: May 14, 2024
• Actual Study Start Date: October 26, 2023
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 15, 2023)

• Number of patients with treatment related adverse events and/or clinical laboratory abnormalities [ Time Frame: Day 28 ]
• Number of patients who experience Dose Limiting Toxicities (DLT) as defined in the protocol [ Time Frame: Day 28 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 15, 2023)

• Area under the concentration-time curve (AUC) of NXP900 [ Time Frame: First dose through Day 29 ]
• Maximum observed concentration (Cmax) of NXP900 [ Time Frame: First dose through Day 29 ]
• Time to peak concentration (Tmax) of NXP900 [ Time Frame: First dose through Day 29 ]
• Half-life (T1/2) of NXP900 [ Time Frame: First dose through Day 29 ]
• Apparent volume of distribution at steady state (Vss/F) of NXP900 [ Time Frame: First dose through Day 29 ]
• Apparent plasma clearance at steady state (Clss/F) of NXP900 [ Time Frame: First dose through Day 29 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers
• Official Title: A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers
• Brief Summary: The purpose of this dose escalation study is to evaluate the safety profile of escalating doses and dose schedules of NXP900.
• Detailed Description: This is a dose escalation study of NXP900 administered to patients with advanced cancers. The study will propose dose and dose schedules for future studies.
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description:

Sequential assignment, dose escalation

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Advanced Solid Tumor

Intervention

Drug: NXP900

NXP900 is an orally administered SRC/YES1 kinase inhibitor

Study Arms

Experimental: Dose Escalation

Escalating doses of NXP900 are planned with a starting dose level of 20 mg once per day.

Intervention: Drug: NXP900

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 15, 2023): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2025
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Provide written informed consent.
2. 18 years old or older.
3. 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.
4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Exclusion Criteria:

1. Subjects with known human epidermal growth factor receptor 2 (HER2+) overexpressing malignancies.
2. Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first dose of NXP900. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer.
3. Ongoing toxic manifestations of previous treatments > Grade 2 with the exception of alopecia and neuropathy.
4. Subjects with treated brain metastases with evidence of progression within 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.
5. Female subjects who can become pregnant (or are already pregnant or lactating), unless they have a negative serum pregnancy test before enrollment and agree to use at least one highly effective form of contraception .
6. 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).
7. Major surgery from which the subject has not yet recovered.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Diane Marsolini; (201) 627-8154; dmarsolini@nuvectis.com

Contact: Shay Shemesh; (201) 614-3153; sshemesh@nuvectis.com

• Listed Location Countries: United Kingdom, United States

Administrative Information

• NCT Number: NCT05873686
• Other Study ID Numbers: NXP900-101
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Nuvectis Pharma, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Nuvectis Pharma, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Nuvectis Pharma, Inc.
• Verification Date: October 2023