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Advanced Solid TumorPhase 1NCT05873686

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

A Phase 1 study testing NXP900 in people with Advanced Solid Tumor and NSCLC (Non-small Cell Lung Cancer), run by Nuvectis Pharma, Inc. at 15 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NXP900
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
15 sitesin 2 countries
Study dates
26 Oct 2023to Jul 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide written informed consent.
  • 18 years old or older.
  • 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.
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Provide written informed consent.
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  • 18 years old or older.
  • Advanced, metastatic, and/or progressive solid tumors with pathogenic molecular alterations:
  • Non-small cell lung cancer (adenocarcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation
  • Non-small cell lung cancer (squamous cell carcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation
  • Renal cancer; NF2 pathogenic mutation
  • Mesothelioma; NF2 pathogenic mutation
  • Other solid tumors with a NF2, FAT1 or LATS1 pathogenic gene mutation or TYMS, YAP1, YES1, or TAZ1 gene amplification, or cholangiocarcinoma with IDH1 or IDH2 mutations.
  • Must have received 1-3 prior therapies appropriate for their tumor type and stage of disease
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (or mRECIST 1.1 for subjects with pleural mesothelioma).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Who cannot join

  • Subjects with known human epidermal growth factor receptor 2 (HER2+) overexpressing malignancies.
  • 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.
  • Ongoing toxic manifestations of previous treatments > Grade 2 with the exception of alopecia and neuropathy.
  • 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.
  • 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 .
  • 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).
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  • Major surgery from which the subject has not yet recovered.
  • Part B:
  • Subjects with the following combination of cancer type and pathogenic molecular alterations are excluded:
  • Subjects with colorectal cancer, glioma, melanoma, or anaplastic thyroid conditions with BRAF mutations.
  • Subjects with NSCLC with BRAF or EGFR mutations or HER2 overexpression.
  • Subjects with breast cancer, gastric cancer, esophageal junction adenocarcinoma or biliary cancer with HER2 alterations,
  • Subjects with anal, penile, cervical or head and neck cancers with a prior history of human papilloma virus (HPV) infection.
  • 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.
  • Ongoing toxic manifestations of previous treatments > Grade 2 with the exception of alopecia and neuropathy.
  • 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 .
  • 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).
  • Major surgery from which the subject has not yet recovered.

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

United States13 sites

  • University of Chicago

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

  • NEXT Oncology Virginia

    Fairfax, Virginia, 22031

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • NEXT Oncology Houston

    Houston, Texas, 77054

  • NEXT Oncology Dallas

    Irving, Texas, 75039

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

Other trials in United States

United Kingdom2 sites

  • Western General Hospital - NHS Lothian

    Edinburgh, EH4 2XU

  • The Royal Marsden NHS Foundation and Trust

    London, SW3 6JJ

Other trials in United Kingdom

About this study

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.

Being tested
NXP900
Keywords
Solid Tumor, Carcinoma, Neoplasms, Adenocarcinoma, YES1, YAP1, TAZ1, NF2, FAT1, LATS1, TYMS, gene amplification, gene mutation, IDH1, IDH2
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Kidney Neoplasms, Mesothelioma, Carcinoma, Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NXP900Drug

    NXP900 is an orally administered SRC/YES1 kinase inhibitor

Study groups in NCT05873686
Study groupRoleWhat they receive
Dose Escalation (Part A)ExperimentalEscalating doses of NXP900 are planned with a starting dose level of 20 mg once per day.
Receives: Drug: NXP900
Dose Expansion (Part B)ExperimentalParticipants will receive the selected dose of NXP900
Receives: Drug: NXP900

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with treatment related adverse events and/or clinical laboratory abnormalities

    Measured: Up to 30 days post treatment

  2. Part A: Number of patients who experience Dose Limiting Toxicities (DLT) as defined in the protocol

    Measured: Day 28

  3. Part B: Objective response rate (ORR)

    Best response of complete response (CR) or partial response (PR) per RECIST 1.1 (or mRECIST 1.1 for subjects with pleural mesothelioma).

    Measured: Up to 24 months

  4. Part B: Duration of Response (DoR)

    Confirmed CR or PR from the first documented response to the date of documented disease progression or death.

    Measured: Up to 24 months

  5. Part B: Disease Control Rate (DCR)

    The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR).

    Measured: Up to 24 months

Secondary outcomes (6)

  1. Area under the concentration-time curve (AUC) of NXP900

    Measured: Up to 24 months

  2. Maximum observed concentration (Cmax) of NXP900

    Measured: Up to 24 months

  3. Time to peak concentration (Tmax) of NXP900

    Measured: Up to 24 months

  4. Half-life (T1/2) of NXP900

    Measured: Up to 24 months

  5. Apparent volume of distribution at steady state (Vss/F) of NXP900

    Measured: Up to 24 months

  6. Apparent plasma clearance at steady state (Clss/F) of NXP900

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2023
  2. Study start26 Oct 2023
  3. Primary completionMar 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Sequential assignment, dose escalation and expansion
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05873686
Sponsor's protocol ID
NXP900-101
Status last verified
Sep 2026
First submitted
15 May 2023
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dash S, Hanson S, King B, Nyswaner K, Foss K, Tesi N, Harvey MJB, Navarro-Marchal SA, Woods A, Poradosu E, Unciti-Broceta A, Carragher NO, Brognard J. The SRC family kinase inhibitor NXP900 demonstrates potent antitumor activity in squamous cell carcinomas. J Biol Chem. 2024 Sep;300(9):107615. doi: 10.1016/j.jbc.2024.107615. Epub 2024 Jul 31.

    PubMed 39089584

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NXP900 in people with Advanced Solid Tumor and NSCLC (Non-small Cell Lung Cancer), run by Nuvectis Pharma, Inc. at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with treatment related adverse events and/or clinical laboratory abnormalities (time frame: Up to 30 days post treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05873686, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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