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

NCT06326411 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-04-20

No results posted yet for this 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.

Conditions

  • Oncology
  • MEK Mutation
  • RAF Gene Mutation
  • Ras (KRAS or NRAS) Gene Mutation
  • Melanoma
  • NSCLC
  • Glioma
  • Solid Tumor, Adult
  • MAPK Pathway Gene Mutation

Interventions

DRUG

NST-628

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

Sponsors & Collaborators

  • Nested Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-09
Primary Completion
2028-11-30
Completion
2029-11-30
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06326411 on ClinicalTrials.gov