RecruitingPhase 1NCT06326411

A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors

A Phase I, Open Label Single-arm Two-part Study to Investigate Safety, Pharmacokinetics, and Preliminary Efficacy of Pan-RAF/MEK Glue NST-628 Oral Tablets in Subject With Solid Tumors Harboring Genetic Alterations in the MAPK Pathway and With Other Solid Tumors


Sponsor

Nested Therapeutics, Inc

Enrollment

230 participants

Start Date

Apr 9, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new oral drug called NST-628 for people with advanced solid tumors. NST-628 targets a specific cancer signaling pathway called RAS/MAPK, which is overactive in many cancers and drives tumor growth. The trial first tests safety at different doses, then looks for effectiveness in specific tumor types with RAS/MAPK abnormalities. **You may be eligible if...** - You are 18 or older - You have a metastatic or locally advanced solid tumor - Standard treatments are no longer working, are not tolerated, or are not suitable for you - Your tumor has a genetic change in the RAS/MAPK pathway (for certain parts of the study) **You may NOT be eligible if...** - Your cancer has spread to the brain and is not stable - You have significant heart rhythm problems - You have other active cancers - You have had certain prior treatments that disqualify you per protocol - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNST-628

NST-628 is a small molecule non-covalent pan-RAF/MEK dual molecular glue targeting RAF and MEK nodes of MAPK pathway.


Locations(23)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

UCLA Hematology/Oncology

Westwood, Los Angeles, California, United States

Sarah Cannon Research Institute at Health ONE

Denver, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Moffitt Cancer Center

Tampa, Florida, United States

Roswell Park

Buffalo, New York, United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Memorial Slone Kettering Cancer Center

New York, New York, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

NEXT Oncology - Austin

Austin, Texas, United States

NEXT Oncology - Dallas

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

START Moutain Region

West Valley City, Utah, United States

NEXT Oncology - Virginia

Fairfax, Virginia, United States

The Kinghorn Cancer Center, St. Vincent's Health Network

Darlinghurst, New South Wales, Australia

Scientia Clinical Research, Ltd

Randwick, New South Wales, Australia

Gallipoli Medical Research Centre- Greenslopes Private Hospital

Greenslopes, Queensland, Australia

Southern Oncology Research Unit

Adelaide, South Australia, Australia

Cabrini Health Limited

Malvern, Victoria, Australia

Cabrini Hospital

Malvern, Victoria, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06326411


Related Trials