Phase 1, open label single-arm two-part study to investigate safety, pharmacokinetics, andpreliminary efficacy of pan-RAF/MEK glue NST-628 oral tablets in subjects with solid tumorsharboring genetic alterations in the MAPK pathway and with other solid

Contact:

NCT Number:

Protocol:

AAAV1862

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I

The purpose of this study is to find out if, and at what dose, NST-628 can safely treat solid cancers in patients who have no other treatment options left. NST-628 has been tested in animals and demonstrated some anti-tumor activity. This research study will be the first in which it will be given to humans and is experimental. “Experimental” means that the study drug has not been approved by any government authority responsible for the regulation of new medicines. This trial will explore what doses of NST-628 are safe and tolerable, as well as see whether NST-628 can slow the growth of, reduce the size of, or get rid of certain types of cancers.

Are you Eligible? (Inclusion Criteria)

  • You are ≥18 years old. 2. You have a life expectancy ≥ 12 weeks 3. You do not have current or history within 6 months of planned Cycle 1 Day 1 of pneumonitis or interstitial lung disease (ILD)' 4. You are able to take oral (by mouth) medication.

Specialty Area(s)

Bladder Cancer , Brain and Spinal Tumors, Breast Cancer, Colon and Rectal Cancer, Esophageal Cancer, Gynecologic Cancers, Cervical Cancer, Ovarian Cancer, Uterine (Endometrial) Cancer, Head and Neck/Oral Cancers, Kidney Cancer/Adrenal Cancer, Lung cancer, Skin cancers, Melanoma, Pancreatic Cancer, Prostate Cancer, Stomach Cancer, Testicular Cancer, Thyroid Cancer

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032