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MAPK Pathway Inhibitor

NST-628 for Cancer (NST-628 Trial)

Phase 1

Recruiting

Research Sponsored by Nested Therapeutics, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Part B: Subjects must be diagnosed with one of the following solid tumors harboring specified genetic alterations based on a validated local test

Must not have

A history or evidence of cardiovascular risk

Part B: prior treatment with any MEK or BRAF inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of a drug called NST-628 in adult patients with advanced solid tumors that have specific genetic mutations. The study will be done in two parts and will focus on

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a Phase 1 trial primarily focused on safety and dosage levels, specific side effects are not listed but may include typical reactions seen in cancer treatments such as fatigue, nausea, skin changes, or other organ-specific issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor has a genetic change linked to the RAS/MAPK pathway.

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My solid tumor has specific genetic changes.

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

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I am mostly active and can care for myself, regardless of my cancer type.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I am not pregnant or breastfeeding.

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I haven't taken any targeted cancer drugs in the last 14 days.

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I can take oral medications without any issues.

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I do not have conditions that affect how my body absorbs pills.

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I have a history of serious eye problems that could increase my risk of retinal vein occlusion.

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I have brain metastases that haven't been treated or are causing symptoms.

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I have not had lung inflammation or ILD in the past 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A and B: Evaluate the safety of NST-628 in patients with advanced solid tumors

Part A: Determine the recommended dose for expansion of NST-628

Part B: Evaluate objective tumor response rate

Secondary study objectives

Part A and B: Characterize the pharmacokinetics of NST-628

Part A and B: Evaluate overall survival (OS)

Part A and B: Evaluate progression free survival (PFS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Part A Dose Escalation and Part B Dose ExpansionExperimental Treatment1 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

0 / 13Eligibility criteria met