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NCT06326411PHASE1Recruiting

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

Nested Therapeutics, Inc

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

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

Interventions

DRUG

NST-628

Interested in This Trial?

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Conditions

OncologyMEK MutationRAF Gene MutationRas (KRAS or NRAS) Gene MutationMelanomaNSCLCGliomaSolid Tumor, AdultMAPK Pathway Gene Mutation

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