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

Part of paid clinical trials in San Francisco, California.

Sponsor
Nested Therapeutics, Inc
Study ID
NCT06326411
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Glioma
  • MAPK Pathway Gene Mutation
  • MEK Mutation
  • Melanoma
  • NSCLC
  • Oncology
  • RAF Gene Mutation
  • Ras (KRAS or NRAS) Gene Mutation
  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NST-628 — DRUG
    NST-628 is a small molecule non-covalent pan-RAF/MEK dual molecular glue targeting RAF and MEK nodes of MAPK pathway.

Study Details

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.

Key Dates

Start date
Apr 9, 2024
Status verified
Apr 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2029

Study Design

Enrollment
230 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A Dose Escalation and Part B Dose Expansion
    Part A will evaluate the safety of NST-628 with advanced solid tumors and determine the recommended dose for expansion of NST-628. Part B will evaluate the objective tumor response rate in subjects with advanced solid tumors harboring specified genetic alterations receiving NST-628 and evaluate the safety of NST-628 in subjects with advanced solid tumors in cohorts defined below: 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

Primary Outcome Measure

Part A and B: Evaluate the safety of NST-628 in patients with advanced solid tumors [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158
Phu Lam Clinical Research Manager
[email protected]
415-818-7994
Virun Monga, MD (PRINCIPAL_INVESTIGATOR)
UCLA Hematology/OncologyWestwood, Los AngelesCalifornia90024
Bartosz Chmielowski, MD
[email protected]
310-794-4955
Bartosz Chmielowski, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute at Health ONEDenverColorado80218
844-482-4812
Gerald Falchook, MD, MS (PRINCIPAL_INVESTIGATOR)
Yale Cancer CenterNew HavenConnecticut06511-
Moffitt Cancer CenterTampaFlorida33612
Justin Martin
[email protected]
813-745-7544
[email protected]
Ahmad Tarhini, MD (PRINCIPAL_INVESTIGATOR)
Roswell ParkBuffaloNew York14263
Study Coordinator
[email protected]
800-767-9355
Igor Puzanov, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Medical CenterNew YorkNew York10032
Nurse Navigation Team
[email protected]
212-342-5162
Benjamin Herzberg, MD (PRINCIPAL_INVESTIGATOR)
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016
Janice Mehnert, MD (PRINCIPAL_INVESTIGATOR)
Memorial Slone Kettering Cancer CenterNew YorkNew York10065
Monica Chen, MD (PRINCIPAL_INVESTIGATOR)
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Jason Luke, MD (PRINCIPAL_INVESTIGATOR)
SCRI Oncology PartnersNashvilleTennessee37203
844-482-4812
Meredith McKean, MD, MPH (PRINCIPAL_INVESTIGATOR)
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232
Angie Boeing
[email protected]
800-811-8480
Jordan D Berlin, MD (PRINCIPAL_INVESTIGATOR)
NEXT Oncology - AustinAustinTexas78758-
NEXT Oncology - DallasDallasTexas75039-
MD Anderson Cancer CenterHoustonTexas77030
Rabia Khan
[email protected]
713-563-4667
Sarina Piha-Paul, MD (PRINCIPAL_INVESTIGATOR)
START Moutain RegionWest Valley CityUtah84119-
NEXT Oncology - VirginiaFairfaxVirginia22031
Blake Patterson
[email protected]
703-783-4505
Mohamad Salkeni, MD (PRINCIPAL_INVESTIGATOR)

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