RecruitingPhase 1NCT05873686
A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers
Sponsor
Nuvectis Pharma, Inc.
Enrollment
140 participants
Start Date
Oct 26, 2023
Study Type
INTERVENTIONAL
Conditions
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 NXP900.
Eligibility
Min Age: 18 Years
Inclusion Criteria17
- Part A
- Provide written informed consent.
- 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.
- 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, TAZ1 gene amplification
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Exclusion Criteria18
- 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).
- 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, EGFR or HER2 alterations.
- 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.
Interventions
DRUGNXP900
NXP900 is an orally administered SRC/YES1 kinase inhibitor
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05873686
Related Trials
Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
NCT0509813227 locations
A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
NCT0699702921 locations
GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors
NCT049774538 locations
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
NCT019505721 location
A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors
NCT0707023253 locations