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

NCT06326411 · Nested Therapeutics, Inc
In plain English

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Official title
A Phase I, Open Label Single-arm Two-part Study to Investigate Safety, Pharmacokinetics, and Preliminary Efficacy of Pan-RAF/MEK Glue NST-628 Oral Tablets in Subject With Solid Tumors Harboring Genetic Alterations in the MAPK Pathway and With Other Solid Tumors
About this study
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
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
Study design
Enrollment target: 230 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-04-09
Estimated completion: 2029-11
Last updated: 2025-11-10
Interventions
Drug: NST-628
Primary outcomes
  • Part A and B: Evaluate the safety of NST-628 in patients with advanced solid tumors (Through study completion, an average of 1 year)
  • Part A: Determine the recommended dose for expansion of NST-628 (The first 28 days of treatment (DLTs))
  • Part B: Evaluate objective tumor response rate (Through study completion, an average of 1 year)
Sponsor
Nested Therapeutics, Inc · industry
Contacts & investigators
ContactCMO · contact · info@nestedtx.com · 617-468-4292
ContactAnn Marie Kennedy · contact · amkennedy@nestedtx.com · 919-427-4225
All locations (23)
UCSF Helen Diller Family Comprehensive Cancer CenterRecruiting
San Francisco, California, United States
UCLA Hematology/OncologyRecruiting
Westwood, Los Angeles, California, United States
Sarah Cannon Research Institute at Health ONERecruiting
Denver, Colorado, United States
Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Roswell ParkRecruiting
Buffalo, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthRecruiting
New York, New York, United States
Columbia University Medical CenterRecruiting
New York, New York, United States
Memorial Slone Kettering Cancer CenterRecruiting
New York, New York, United States
UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer CenterRecruiting
Nashville, Tennessee, United States
NEXT Oncology - AustinRecruiting
Austin, Texas, United States
NEXT Oncology - DallasRecruiting
Dallas, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
START Moutain RegionRecruiting
West Valley City, Utah, United States
NEXT Oncology - VirginiaRecruiting
Fairfax, Virginia, United States
The Kinghorn Cancer Center, St. Vincent's Health NetworkRecruiting
Darlinghurst, New South Wales, Australia
Scientia Clinical Research, LtdRecruiting
Randwick, New South Wales, Australia
Gallipoli Medical Research Centre- Greenslopes Private HospitalRecruiting
Greenslopes, Queensland, Australia
Southern Oncology Research UnitRecruiting
Adelaide, South Australia, Australia
Cabrini Health LimitedRecruiting
Malvern, Victoria, Australia
Cabrini HospitalRecruiting
Malvern, Victoria, Australia