Study of NST-628 for Advanced Solid Tumors with MAPK Pathway Mutations
This study is testing a new oral tablet, NST-628, for people with advanced solid tumors that have specific genetic changes (MEK, RAF, KRAS, or NRAS mutations). NST-628 works by targeting the RAF and MEK parts of the MAPK pathway, which are involved in cancer growth. The study aims to find a safe and effective dose of NST-628 and see how well it shrinks tumors. You might be eligible if you are at least 18 years old, have a solid tumor that has spread or is locally advanced, and have already tried standard treatments. The study is currently recruiting participants.
- Study design
- This is a Phase 1, open-label, single-arm study with two parts: a dose escalation part (Part A) and a dose expansion part (Part B). It plans to enroll up to 230 participants.
- What's involved
- You would take NST-628 orally once daily in 28-day cycles. The study will involve regular visits to monitor your safety and how well the treatment is working.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and tumor response will be monitored through study completion, which is expected to be an average of 1 year.
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 Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors
At a glance
Conditions
Where it's being run
23 sites across 14 statesWho to contact
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What this trial measures
- Part A and B: Evaluate the safety of NST-628 in patients with advanced solid tumorsThrough study completion, an average of 1 year
Adverse effects
- Part A: Determine the recommended dose for expansion of NST-628The first 28 days of treatment (DLTs)
Dose limiting toxicities (DLTs)
- Part B: Evaluate objective tumor response rateThrough study completion, an average of 1 year
Objective response per RECIST v. 1.1 or other response assessment tool standard for a given tumor type.