Phase 1 Study of NXP900 for Advanced Cancers
This study is testing a new oral drug called NXP900 for people with advanced solid tumors, including non-small cell lung cancer, renal cancer, and mesothelioma. NXP900 works by blocking certain proteins called SRC/YES1 kinase. The main goals are to see how safe NXP900 is and what side effects it might cause, especially in the first month. Researchers will also look at how many patients respond to the treatment over two years. You might be able to join if you are 18 or older, have advanced cancer with no other effective treatments, and your cancer can be measured. This is a first-in-human study, meaning it's the first time NXP900 is being tested in people.
- Study design
- This is a Phase 1, multi-center study that is open-label, meaning both you and your doctors will know you are receiving NXP900. It plans to enroll 140 participants and has two parts: a dose escalation part (Part A) and an expansion part (Part B).
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will monitor for side effects for up to 30 days after treatment. They will also track how well the treatment works for up to 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers
At a glance
Conditions
Where it's being run
15 sites across 12 statesStudy leadership
- Udai Banerji, Prof · PRINCIPAL_INVESTIGATOR · Institute of Cancer Research, Royal Marsden NHS Foundation Trust
- Gerald Falchook, MD · PRINCIPAL_INVESTIGATOR · Sarah Cannon Cancer Institute, HealthOne Denver
Who to contact
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What this trial measures
- Number of patients with treatment related adverse events and/or clinical laboratory abnormalitiesUp to 30 days post treatment
- Part A: Number of patients who experience Dose Limiting Toxicities (DLT) as defined in the protocolDay 28
- Part B: Objective response rate (ORR)Up to 24 months
Best response of complete response (CR) or partial response (PR) per RECIST 1.1 (or mRECIST 1.1 for subjects with pleural mesothelioma).
- Part B: Duration of Response (DoR)Up to 24 months
Confirmed CR or PR from the first documented response to the date of documented disease progression or death.
- Part B: Disease Control Rate (DCR)Up to 24 months
The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR).