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ACTIVE NOT RECRUITINGPhase1

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

Sponsor: Nuvectis Pharma, Inc.

NCT ID: NCT05873686

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
NXP900 (drug)
How long the study runs
Study runs about 45 months (dates as stated)
About the drug or intervention
NXP900 — drug: NXP900 is an orally administered SRC/YES1 kinase inhibitor
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
140
Started
2023-10-26
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for advanced solid tumor
  • • Phase1 - 140 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with advanced solid tumor

Where?

  • • Edinburgh - Western General Hospital - NHS Lothian
  • • London - The Royal Marsden NHS Foundation and Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Advanced Solid TumorNSCLC (Non-small Cell Lung Cancer)Renal CancerMesotheliomaNon-Small Cell Squamous Lung CancerNon-small Cell Lung Adenocarcinoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

HER2have a negativeIDH1IDH2BRAFEGFR

What the study is looking for

  • ✓Provide written agreement to take part.
  • ✓18 years old or older.
  • ✓Advanced, that has spread, and/or progressive solid tumors for whom there is no authorized or effective therapy...
  • ✓cancer that can be measured on scans according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
  • ✓activity scale (ECOG) performance status of 0-1.

Who cannot take part

  • ✗Subjects with known human epidermal growth factor receptor 2 (HER2+) overexpressing malignancies.
  • ✗Ongoing toxic manifestations of previous treatments \> Grade 2 with the exception of alopecia and neuropathy.
  • ✗Male subjects with partners of childbearing potential, unless they agree to take measures not to father children by...
  • ✗Major surgery from which the subject has not yet recovered.
  • ✗Part B:
See the full criteria
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, or TAZ1 gene amplification, or cholangiocarcinoma with IDH1 or IDH2 mutations. 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 (or mRECIST 1.1 for subjects with pleural mesothelioma). 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 or EGFR mutations or HER2 overexpression. 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.

Where Is This Study? (2 UK sites)

Western General Hospital - NHS Lothian

Edinburgh EH4 2XU, United Kingdom

The Royal Marsden NHS Foundation and Trust

London SW3 6JJ, United Kingdom

Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416
Data sourced from ClinicalTrials.gov · Last verified: 2026-09