A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors
Start Date
4/9/2024
Completion Date
11/1/2029
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.
Detailed Description
The study includes two parts, a dose escalation part (Part A) followed by a dose expansion part (Part B). Part A will estimate the maximum tolerated dose (MTD) in dose escalation cohorts in patients with advanced solid tumors for whom no standard therapy is available in order to establish the recommended dose for expansion (RDE). Successive cohorts of subjects will receive escalating doses of NST-628 orally once daily in 28-day cycles. Bayesian Optimal Interval (BOIN) method will be used for dose escalation. Once MTD is reached or dose escalation is stopped prior to reaching MTD and provisional RDE selected, the provisional RDE level will be expanded. If warranted by dose/toxicity/anti-tumor activity observations, additional, lower dose level(s) may also be expanded. Part B of the study will include up to 6 cohorts of approximately up to 30 subjects each with select MAPK pathway mutant solid tumors enrolled at the RDE in order to explore benefit from treatment as suggested by preclinical findings and will better define the safety profile of NST-628 at the RDE. Additional safety information gathered in Part B may be used to modify the dose recommended for future studies. The end of the study is the last visit of the last subject.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
NST-628
Conditions
Locations
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158
United States
UCLA Hematology/Oncology
Westwood, Los Angeles, California 90024
United States
Sarah Cannon Research Institute at Health ONE
Denver, Colorado 80218
United States
Yale Cancer Center
New Haven, Connecticut 06511
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Roswell Park
Buffalo, New York 14263
United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United States
Columbia University Medical Center
New York, New York 10032
United States
Memorial Slone Kettering Cancer Center
New York, New York 10065
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232
United States
NEXT Oncology - Austin
Austin, Texas 78758
United States
NEXT Oncology - Dallas
Dallas, Texas 75039
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
START Moutain Region
West Valley City, Utah 84119
United States
NEXT Oncology - Virginia
Fairfax, Virginia 22031
United States
The Kinghorn Cancer Center, St. Vincent's Health Network
Darlinghurst, New South Wales 2010
Australia
Scientia Clinical Research, Ltd
Randwick, New South Wales 2031
Australia
Gallipoli Medical Research Centre- Greenslopes Private Hospital
Greenslopes, Queensland 120
Australia
Southern Oncology Research Unit
Adelaide, South Australia 5042
Australia
Cabrini Health Limited
Malvern, Victoria 3144
Australia
Cabrini Hospital
Malvern, Victoria 3144
Australia