Actively Recruiting
A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors
Led by Nested Therapeutics, Inc · Updated on 2026-04-20
230
Participants Needed
23
Research Sites
290 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at consent
- Histologically or cytologically confirmed metastatic or locally advanced solid tumor with no effective standard therapy
- For Part A: any solid tumor with genetic alteration or dependence on the RAS/MAPK pathway
- For Part B: diagnosed with melanoma or non-melanoma solid tumors harboring specific MAPK pathway mutations confirmed by validated local tests
- Newly obtained or archived tumor tissue available
- Measurable disease by RECIST 1.1 or appropriate assessment tool (Part B)
- Performance status: ECOG 0 or 1 (non-glioma tumors), Karnofsky ≥70 and ECOG 0 or 1 (glioma)
- Adequate organ function
- Informed consent signed
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Conditions interfering with oral intake or intestinal absorption of NST-628
- History or evidence of significant retinal pathology increasing risk of retinal vein occlusion
- History or evidence of cardiovascular risk
- Pneumonitis or interstitial lung disease within 6 months before starting treatment
- Prior MEK or BRAF inhibitor treatment (Part B)
- Untreated or symptomatic central nervous system metastases
- Chemotherapy, radiation, gene therapy, vaccine therapy, or anti-cancer antibodies/ADCs within 28 days before treatment
- Targeted small molecule agents within 14 days or 5 half-lives before treatment
- Pregnant or breastfeeding females
- Refusal to use effective contraception during the trial and for 6 months after last dose (fertile patients)
- Serious or unstable systemic disorders incompatible with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
2
UCLA Hematology/Oncology
Westwood, Los Angeles, California, United States, 90024
Actively Recruiting
3
Sarah Cannon Research Institute at Health ONE
Denver, Colorado, United States, 80218
Actively Recruiting
4
Yale Cancer Center
New Haven, Connecticut, United States, 06511
Completed
5
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
6
Roswell Park
Buffalo, New York, United States, 14263
Actively Recruiting
7
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
8
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
9
Memorial Slone Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
10
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
11
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
12
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
NEXT Oncology - Austin
Austin, Texas, United States, 78758
Active, Not Recruiting
14
NEXT Oncology - Dallas
Dallas, Texas, United States, 75039
Active, Not Recruiting
15
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
16
START Moutain Region
West Valley City, Utah, United States, 84119
Completed
17
NEXT Oncology - Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
18
The Kinghorn Cancer Center, St. Vincent's Health Network
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
19
Scientia Clinical Research, Ltd
Randwick, New South Wales, Australia, 2031
Completed
20
Gallipoli Medical Research Centre- Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 120
Actively Recruiting
21
Southern Oncology Research Unit
Adelaide, South Australia, Australia, 5042
Actively Recruiting
22
Cabrini Health Limited
Malvern, Victoria, Australia, 3144
Actively Recruiting
23
Cabrini Hospital
Malvern, Victoria, Australia, 3144
Actively Recruiting
Research Team
C
CMO
CONTACT
A
Ann Marie Kennedy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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