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Trial record 1 of 1 for:    nxp900
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A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers

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ClinicalTrials.gov Identifier: NCT05873686
Recruitment Status : Recruiting
First Posted : May 24, 2023
Last Update Posted : February 6, 2024
Sponsor:
Information provided by (Responsible Party):
Nuvectis Pharma, Inc.

Study Description
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Brief Summary:
The purpose of this dose escalation study is to evaluate the safety profile of escalating doses and dose schedules of NXP900.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: NXP900 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential assignment, dose escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers
Actual Study Start Date : October 26, 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : January 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation
Escalating doses of NXP900 are planned with a starting dose level of 20 mg once per day.
 Drug: NXP900
NXP900 is an orally administered SRC/YES1 kinase inhibitor


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05873686


Contacts
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Contact: Diane Marsolini (201) 627-8154 dmarsolini@nuvectis.com
Contact: Shay Shemesh (201) 614-3153 sshemesh@nuvectis.com

Locations
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United States, Colorado
Sarah Cannon Research Institute at HealthONE Recruiting
Denver, Colorado, United States, 80218
Contact    720-754-2610      
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact    503-494-6865      
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jordi Rodon Ahnert, MD, PhD    713-792-5603      
United Kingdom
The Royal Marsden NHS Foundation and Trust Recruiting
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Nuvectis Pharma, Inc.
Investigators
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Principal Investigator: Udai Banerji, Prof Institute of Cancer Research, Royal Marsden NHS Foundation Trust
More Information
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Responsible Party: Nuvectis Pharma, Inc.
ClinicalTrials.gov Identifier: NCT05873686    
Other Study ID Numbers: NXP900-101
First Posted: May 24, 2023    Key Record Dates
Last Update Posted: February 6, 2024
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nuvectis Pharma, Inc.:
Solid Tumor
Carcinoma
Neoplasms
Adenocarcinoma