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Tests treatment safety and results for Oncology
Official title A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors
ClinicalTrials.gov ID: NCT06326411
What this study is testing
What is NST-628?
NST-628 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for oncology.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people are eligible to be included in the study only if all of the following criteria apply:
- people 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...
- people who have a histologically or cytologically documented metastatic or locally advanced solid tumor, for which standard of care (SoC) therapy...
- Part A: people with any solid tumor with genetic alteration of or evidence of tumor dependence upon the RAS/MAPK pathway (subject to additional...
- Part B: people must be diagnosed with one of the following solid tumors harboring specified genetic alterations based on a validated local test: i...
You likely can't join if
- people are excluded from the study if any of the following criteria apply:
- Conditions interfering with oral intake of NST-628
- Conditions interfering with intestinal absorption of an orally administered drug
- A history or current evidence of significant retinal pathology leading to increased risk of RVO
- A history or evidence of cardiovascular risk
- Current or history within 6 months of planned Cycle 1 Day 1 of pneumonitis or interstitial lung disease (ILD)
See the full eligibility criteria
- people are eligible to be included in the study only if all of the following criteria apply:
- people 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.
- people 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...
- Part A: people 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: people must be diagnosed with one of the following solid tumors harboring specified genetic alterations based on a validated local test: i. Melanoma Cohorts:
- Activating NRAS mutations
- Select BRAF alterations ii. Non-Melanoma Cohorts:
- Solid tumors with NRAS activating mutations
- Solid tumors with KRAS activating mutations
- Solid tumors with select BRAF alterations
- Glioma with BRAF alterations
- Newly obtained or archived tumor tissue is required
- 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)
- Performance status
- Solid tumors other than glioma: ECOG 0 or 1
- Glioma: Karnofsky ≥ 70 and ECOG 0 or 1
- Have adequate organ function
- Understand and voluntarily sign an Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to any study-specific evaluation.
- Life expectancy ≥ 12 weeks
- people are excluded from the study if any of the following criteria apply:
- Conditions interfering with oral intake of NST-628
- Conditions interfering with intestinal absorption of an orally administered drug
- A history or current evidence of significant retinal pathology leading to increased risk of RVO
- A history or evidence of cardiovascular risk
- Current or history within 6 months of planned Cycle 1 Day 1 of pneumonitis or interstitial lung disease (ILD)
- Part B: prior treatment with any MEK or BRAF inhibitor
- Untreated or symptomatic central nervous system (CNS) metastases
- Chemotherapy, radiation, gene therapy, vaccine therapy, or anti-cancer antibodies / ADCs within 28 days of Cycle 1 Day 1
- Targeted small molecule agents within 14 days or 5 half-lives of Cycle 1 Day 1
- Females who are pregnant or breastfeeding.
- 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
- Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Westwood, Los Angeles, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Tampa, Florida, United States
- Buffalo, New York, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
- Darlinghurst, New South Wales, Australia
- Randwick, New South Wales, Australia
- Greenslopes, Queensland, Australia
- Adelaide, South Australia, Australia
- Malvern, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Westwood, Los Angeles, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Tampa, Florida, United States; Buffalo, New York, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.