A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers
NCT ID: NCT05873686
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
140 participants
INTERVENTIONAL
2023-10-26
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation (Part A)
Escalating doses of NXP900 are planned with a starting dose level of 20 mg once per day.
NXP900
NXP900 is an orally administered SRC/YES1 kinase inhibitor
Dose Expansion (Part B)
Participants will receive the selected dose of NXP900
NXP900
NXP900 is an orally administered SRC/YES1 kinase inhibitor
Interventions
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NXP900
NXP900 is an orally administered SRC/YES1 kinase inhibitor
Eligibility Criteria
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Inclusion Criteria
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.
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
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:
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.
18 Years
ALL
No
Sponsors
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Nuvectis Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Udai Banerji, Prof
Role: PRINCIPAL_INVESTIGATOR
Institute of Cancer Research, Royal Marsden NHS Foundation Trust
Gerald Falchook, MD
Role: PRINCIPAL_INVESTIGATOR
Sarah Cannon Cancer Institute, HealthOne Denver
Locations
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Mayo Clinic
Phoenix, Arizona, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
Oregon Health and Science University
Portland, Oregon, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Western General Hospital - NHS Lothian
Edinburgh, , United Kingdom
The Royal Marsden NHS Foundation and Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Jordi Rodon Ahnert, MD, PhD
Role: primary
Other Identifiers
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NXP900-101
Identifier Type: -
Identifier Source: org_study_id
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