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)
Part A and B: Evaluate the safety of NST-628 in patients with advanced solid tumors — Through study completion, an average of 1 year Adverse effects
Part A: Determine the recommended dose for expansion of NST-628 — The first 28 days of treatment (DLTs) Dose limiting toxicities (DLTs)
Part B: Evaluate objective tumor response rate — Through study completion, an average of 1 year Objective response per RECIST v. 1.1 or other response assessment tool standard for a given tumor type.
Trial sites (23)
Facility
City
Region
Status
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
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.
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