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

February 27, 2026 updated by: Nuvectis Pharma, Inc.
This is a multi-center, first-in-human, open label, dose escalation (Part A) and expansion (Part B) Phase 1 study in subjects with advanced solid tumors and in subjects with solid tumors with selected genetic alterations that are either direct (YES1 amplification) or dependent (Hippo Pathway alterations) targets of NXP900.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

140

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
      • Edinburgh, United Kingdom, EH4 2XU
        • Completed
        • Western General Hospital - NHS Lothian
      • London, United Kingdom, SW3 6JJ
        • Completed
        • The Royal Marsden NHS Foundation and Trust
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Phone Number: 855-776-0015
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Sarah Cannon Research Institute at HealthONE
        • Contact:
          • Phone Number: 720-754-2610
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Phone Number: 855-776-0015
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
          • Phone Number: 503-494-6865
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
          • Jordi Rodon Ahnert, MD, PhD
          • Phone Number: 713-792-5603
      • Houston, Texas, United States, 77054
        • Recruiting
        • NEXT Oncology Houston
      • Irving, Texas, United States, 75039
        • Recruiting
        • Next Oncology Dallas
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Next Oncology Virginia

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Part A

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.

Part B:

Inclusion Criteria:

  1. Provide written informed consent.
  2. 18 years old or older.

  3. Advanced, metastatic, and/or progressive solid tumors with pathogenic molecular alterations:

    1. Non-small cell lung cancer (adenocarcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation
    2. Non-small cell lung cancer (squamous cell carcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation
    3. Renal cancer; NF2 pathogenic mutation
    4. Mesothelioma; NF2 pathogenic mutation
    5. Other solid tumors with a NF2, FAT1 or LATS1 pathogenic gene mutation or TYMS, YAP1, YES1, TAZ1 gene amplification
  4. Must have received 1-3 prior therapies appropriate for their tumor type and stage of disease
  5. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Exclusion Criteria:

  1. Subjects with the following combination of cancer type and pathogenic molecular alterations are excluded:

    1. Subjects with colorectal cancer, glioma, melanoma, or anaplastic thyroid conditions with BRAF mutations.
    2. Subjects with NSCLC with BRAF, EGFR or HER2 alterations.
    3. Subjects with breast cancer, gastric cancer, esophageal junction adenocarcinoma or biliary cancer with HER2 alterations,
  2. Subjects with anal, penile, cervical or head and neck cancers with a prior history of human papilloma virus (HPV) infection.
  3. Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days (42 days for nitrosoureas, mitomycin-C) prior to first dose of NXP900. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer.
  4. Ongoing toxic manifestations of previous treatments > Grade 2 with the exception of alopecia and neuropathy.
  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.

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: Dose Escalation (Part A)
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
Experimental: Dose Expansion (Part B)
Participants will receive the selected dose of NXP900
Drug: NXP900
NXP900 is an orally administered SRC/YES1 kinase inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with treatment related adverse events and/or clinical laboratory abnormalities
Time Frame: Up to 30 days post treatment
Up to 30 days post treatment
Part A: Number of patients who experience Dose Limiting Toxicities (DLT) as defined in the protocol
Time Frame: Day 28
Day 28
Part B: Objective response rate (ORR)
Time Frame: Up to 24 months
Best response of complete response (CR) or partial response (PR) per RECIST 1.1
Up to 24 months
Part B: Duration of Response (DoR)
Time Frame: Up to 24 months
Confirmed CR or PR from the first documented response to the date of documented disease progression or death.
Up to 24 months
Part B: Disease Control Rate (DCR)
Time Frame: Up to 24 months
The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR).
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve (AUC) of NXP900
Time Frame: Up to 24 months
Up to 24 months
Maximum observed concentration (Cmax) of NXP900
Time Frame: Up to 24 months
Up to 24 months
Time to peak concentration (Tmax) of NXP900
Time Frame: Up to 24 months
Up to 24 months
Half-life (T1/2) of NXP900
Time Frame: Up to 24 months
Up to 24 months
Apparent volume of distribution at steady state (Vss/F) of NXP900
Time Frame: Up to 24 months
Up to 24 months
Apparent plasma clearance at steady state (Clss/F) of NXP900
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

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

Sponsor

Nuvectis Pharma, Inc.

Investigators

  • Principal Investigator: Udai Banerji, Prof, Institute of Cancer Research, Royal Marsden NHS Foundation Trust
  • Principal Investigator: Gerald Falchook, MD, Sarah Cannon Cancer Institute, HealthOne Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 26, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NXP900-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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