Oncology study: NST-628
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?
This is an investigational oral medicine being studied for advanced solid tumors driven by specific gene changes. It is designed to block two key proteins in the MAPK pathway that help cancer cells grow.
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 study is testing how safe the new pill is and how well it works. It also looks at how the body handles the medicine.
- Who it's for
- You may be able to join if you are an adult with a specific type of cancer. Your cancer must have certain gene changes. You must have tried other standard treatments first.
- What's involved
- You would take the NST-628 pill by mouth. The team will check your health and blood levels of the drug.
- Time commitment
- The study has two parts to find the right dose and check safety.
- 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 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...
- Activating NRAS mutations
- Solid tumors with NRAS activating mutations
You likely can't join if
- 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
See the full eligibility criteria
- 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)
- Activating NRAS mutations
- 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
- 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 is enrolling
- San Francisco, California, United States
- Westwood, Los Angeles, California, United States
- Denver, Colorado, 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
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Darlinghurst, 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, but 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?
This study is enrolling now at San Francisco, California, United States; Westwood, Los Angeles, California, United States; Denver, Colorado, United States; Tampa, Florida, United States; Buffalo, New York, United States; New York, New York, United States and 8 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.