NST-628 for Cancer

(NST-628 Trial)

Recruiting at 23 trial locations

Overseen By Ann Marie Kennedy

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Nested Therapeutics, Inc

Must not be taking: MEK inhibitors, BRAF inhibitors

Disqualifiers: Retinal pathology, Cardiovascular risk, ILD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

230 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain cancer treatments before starting, such as chemotherapy, radiation, and targeted small molecule agents, for a specific period. However, it doesn't specify about other medications, so you should discuss your current medications with the trial team.

Eligibility Criteria

This trial is for adults with advanced solid tumors that have mutations in the MAPK pathway and who've run out of standard treatment options. It's open to those over 18 or at legal consent age, with certain types of genetic alterations like NRAS or BRAF mutations, and requires a confirmed diagnosis through tissue samples.

Inclusion Criteria

My advanced cancer has no standard treatment options left, or I can't tolerate them.

Understand and voluntarily sign an Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to any study-specific evaluation

I am at least 18 years old or of legal age to consent where the study is conducted.

Exclusion Criteria

I haven't had cancer treatments like chemotherapy or radiation in the last 28 days.

I have a history of heart problems or am at risk for heart disease.

I have previously been treated with a MEK or BRAF inhibitor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part A)

Participants receive escalating doses of NST-628 to determine the maximum tolerated dose (MTD) in 28-day cycles

28 days per cycle

Dose Expansion (Part B)

Participants receive NST-628 at the recommended dose for expansion (RDE) to evaluate safety and objective tumor response rate

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• NST-628

Trial Overview The study tests NST-628 oral tablets' safety and effectiveness on patients with specific solid tumors. It's an early-stage (Phase 1), non-randomized trial where all participants receive multiple doses of NST-628 to assess its impact on their cancer.

Participant Groups

Group I: Part A Dose Escalation and Part B Dose Expansion Experimental Treatment 1 Intervention

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

NST-628 is already approved in United States for the following indications:

Approved in United States as NST-628 for:

• Advanced solid tumors with MAPK pathway mutations

Who Is Running the Clinical Trial?

Nested Therapeutics, Inc

Lead Sponsor

Trials

1

Recruited

230+