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Clinical Trials in the USA / NCT06326411
Recruiting Phase 1

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

NCT06326411 · tracked via the Priya Life Science USA tracker
Sponsor
Nested Therapeutics, Inc
Phase
Phase 1
Started
2024-04-09
Last updated
2026-04-20

Condition(s) studied

OncologyMEK MutationRAF Gene MutationRas (KRAS or NRAS) Gene MutationMelanomaNSCLCGliomaSolid Tumor, AdultMAPK Pathway Gene Mutation

Investigational drug(s) / intervention(s)

NST-628

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Subjects are eligible to be included in the study only if all of the following criteria apply: 1. Subjects must be ≥18 years old (or of legal age of consent in the country in which the study is taking place) at the time of signing the informed consent. 2. Subjects who have a histologically or cytologically documented metastatic or locally advanced solid tumor, for which standard of care (SoC) therapy does not exist, no longer provides benefit, or is not tolerated by the subject, or the subject has been assessed by the Investigator as not being suitable for SoC therapy. 1. Part A: Subjects with any solid tumor with genetic alteration of or evidence of tumor dependence upon the RAS/MAPK pathway (subject to additional restrictions specified in the study protocol) 2. Part B: Subjects must be diagnosed with one of the following solid tumors harboring specified genetic alterations based on a validated local test: i. Melanoma Cohorts: 1. Activating NRAS mutations 2. Select BRAF alterations ii. Non-Melanoma Cohorts: 1. Solid tumors with NRAS activating mutations 2. Solid tumors with KRAS activating mutations 3. Solid tumors with select BRAF alterations 4. Glioma with BRAF alterations 3. Newly obtained or archived tumor tissue is required 4. Part B: measurable disease as defined by RECIST Version 1.1 or by other disease assessment tool standard for a given tumor type (if RECIST v. 1.1 is not standard) 5. Performance status 1. Solid tumors other than glioma: ECOG 0 or 1 2. Glioma: Karnofsky ≥ 70 and ECOG 0 or 1 6. Have adequate organ function 7. Understand and voluntarily sign an Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to any study-specific evaluation. 8. Life expectancy ≥ 12 weeks Exclusion Criteria: Subjects are excluded from the study if any of the following criteria apply: 1. Conditions interfering with oral intake of NST-628 2. Conditions interfering with intestinal absorption of an orally administered drug 3. A history or current evidence of significant retinal pathology leading to increased risk of RVO 4. A history or evidence of cardiovascular risk 5. Current or history within 6 months of planned Cycle 1 Day 1 of pneumonitis or interstitial lung disease (ILD) 6. Part B: prior treatment with any MEK or BRAF inhibitor 7. Untreated or symptomatic central nervous system (CNS) metastases 8. Chemotherapy, radiation, gene therapy, vaccine therapy, or anti-cancer antibodies / ADCs within 28 days of Cycle 1 Day 1 9. Targeted small molecule agents within 14 days or 5 half-lives of Cycle 1 Day 1 10. Females who are pregnant or breastfeeding. 11. For fertile patients (female able to become pregnant or male able to father a child), refusal to use effective contraception during the period of the trial and for 6 months after the last dose of NST-628 12. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study

Primary outcome measure(s)

Trial sites (23)

FacilityCityRegionStatus
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

Official registry record

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