RecruitingOncologyMEK MutationRAF Gene Mutation

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

Eligible age

18+ yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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.

Sponsor: Nested Therapeutics, Inc

You may qualify if…

✓ 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

You may not qualify if…

✕ 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