Actively Recruiting
Phase 1 Study of Oral NXP900 for Adults with Advanced Solid Tumors Including Lung, Renal Cancer, and Mesothelioma
Led by Nuvectis Pharma, Inc. · Updated on 2026-07-09
140
Participants Needed
15
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multi-center, first-in-human, open-label Phase 1 study to evaluate NXP900, an oral SRCYES1 kinase inhibitor, in adults with advanced solid tumors. The study focuses on patients with advanced cancers, including lung, renal cancer, mesothelioma, and tumors with specific genetic alterations such as YES1 amplification or Hippo pathway-related mutations. It aims to assess safety, dosage, and preliminary effectiveness of NXP900 in these patients. The study has two parts Part A is a dose escalation phase starting at 20 mg once daily, where participants receive increasing doses of NXP900 to find a suitable dose. Part B is a dose expansion phase where participants with tumors harboring specific genetic markers receive a selected dose of NXP900. Treatments are administered orally, and the study includes both patients with advanced solid tumors without effective therapies and those with tumors having certain pathogenic molecular alterations. Participants will undergo regular assessments including monitoring for treatment-related side effects, clinical laboratory tests, and tumor response evaluations using RECIST criteria. Safety evaluations occur up to 30 days post-treatment, while efficacy measures such as objective response rate, duration of response, and disease control rate are followed for up to 24 months. Pharmacokinetic testing tracks how the drug is absorbed and processed. The total study duration extends to July 2027, with ongoing monitoring of patient health and treatment effects.
CONDITIONS
Brief Title
A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent.
- Be 18 years old or older.
- Have advanced, metastatic, or progressive solid tumors with no authorized or effective therapy available, or if such therapies are inappropriate.
- Have measurable disease according to RECIST Version 1.1.
- Have an ECOG performance status of 0 or 1.
- For Part B: Have tumors with specific genetic alterations (e.g., YES1 amplification, NF2 mutation) and have received 1-3 prior appropriate therapies.
You will not qualify if you...
- Have HER2 overexpressing malignancies (Part A) or specific cancer types with certain mutations such as BRAF or EGFR (Part B).
- Received radiotherapy (except palliative), endocrine therapy, chemotherapy, or investigational agents within 28 days (42 days for some drugs) before starting NXP900.
- Have ongoing toxic effects from previous treatments greater than Grade 2, except for alopecia and neuropathy.
- Have progressing brain metastases within 28 days after CNS-directed treatment.
- Are pregnant, lactating, or able to become pregnant without agreeing to effective contraception.
- Male with partners of childbearing potential not agreeing to use contraception.
- Have not recovered from major surgery.
Research Team
E
Erin Belshaw
S
Shay Shemesh
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