A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
NST-628: NST-628 is a small molecule non-covalent pan-RAF/MEK dual molecular glue targeting RAF and MEK nodes of MAPK pathway.
Study summary
This is a two-part Phase 1, open label, multi-center, single arm, non-randomized, multiple dose, safety, pharmacokinetic (PK) and preliminary efficacy study of single agent NST-628 in adult patients with MAPK pathway mutated/dependent advanced solid tumors who have exhausted standard treatment options.
Eligibility
Primary outcome measure(s)
- Part A and B: Evaluate the safety of NST-628 in patients with advanced solid tumors — Through study completion, an average of 1 year
Adverse effects - Part A: Determine the recommended dose for expansion of NST-628 — The first 28 days of treatment (DLTs)
Dose limiting toxicities (DLTs) - Part B: Evaluate objective tumor response rate — Through 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.
Trial sites (23)
| Facility | City | Region | Status |
|---|---|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | Recruiting |
| UCLA Hematology/Oncology | Westwood, Los Angeles | California | Recruiting |
| Sarah Cannon Research Institute at Health ONE | Denver | Colorado | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | Completed |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| Roswell Park | Buffalo | New York | Recruiting |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | Recruiting |
| Columbia University Medical Center | New York | New York | Recruiting |
| Memorial Slone Kettering Cancer Center | New York | New York | Recruiting |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | Recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | Recruiting |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | Recruiting |
| NEXT Oncology - Austin | Austin | Texas | Active Not Recruiting |
| NEXT Oncology - Dallas | Dallas | Texas | Active Not Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| START Moutain Region | West Valley City | Utah | Completed |
| NEXT Oncology - Virginia | Fairfax | Virginia | Recruiting |
| The Kinghorn Cancer Center, St. Vincent's Health Network | Darlinghurst | New South Wales | Recruiting |
| Scientia Clinical Research, Ltd | Randwick | New South Wales | Completed |
| Gallipoli Medical Research Centre- Greenslopes Private Hospital | Greenslopes | Queensland | Recruiting |
| Southern Oncology Research Unit | Adelaide | South Australia | Recruiting |
| Cabrini Health Limited | Malvern | Victoria | Recruiting |
| Cabrini Hospital | Malvern | Victoria | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06326411 on ClinicalTrials.gov ↗ ← All trials in the USA