Recruiting

Testing a New Cancer Drug for Advanced Solid Tumors

Plain-English translation of NCT06586957 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

This is one of the first times this treatment has been tested in people.

What is this trial?

This is a first-in-human clinical trial testing a new drug called , which is designed to treat advanced cancers that have spread or cannot be surgically removed. The trial aims to find the safest and most effective dose of this medication, and to see whether it can slow or stop the growth of certain cancers—including breast, ovarian, endometrial, gastric, and lung cancers. The medication works by targeting a protein called CDK2, which cancer cells need to survive and grow.

Many patients with advanced cancers run out of treatment options when standard therapies stop working. This medication represents a new approach that may help people whose cancers have become resistant to existing treatments, particularly those with a genetic feature called CCNE1 amplification.

Do you qualify?

You likely qualify if…

you have been diagnosed with an advanced or metastatic solid tumor (such as ovarian, endometrial, gastric, lung, or breast cancer) that has stopped responding to standard treatment
your cancer has a confirmed diagnosis from a pathology report and has spread or cannot be surgically removed
you have already tried at least one standard treatment and either did not tolerate it or it did not work for your condition
you have adequate organ function (kidney, liver, heart, and blood counts are working well enough)
you are able to swallow oral medications by mouth
you are willing to provide archived tumor tissue samples for research

You likely don't qualify if…

you are pregnant or breastfeeding, or unwilling to use effective contraception if you have female reproductive organs
you have severe organ damage or very poor organ function
you cannot swallow pills or take oral medications
you have had more than the allowed number of prior cancer treatments for your specific cancer type

What participation looks like

The trial has two main phases. In the first phase (dose escalation), researchers will gradually increase the dose of the medication to find the safest and most effective level, with small groups of patients receiving different doses. In the second phase (dose expansion), more patients will receive the dose that was determined to be best, so researchers can confirm how well the medication works. Throughout the trial, you will take the medication by mouth and attend regular clinic visits for blood tests, scans, and check-ups to monitor how your cancer responds and any side effects you may experience.

AI-generated summary from trial data · Jun 13, 2026 · Not medical advice

Trial locations(19 sites)

United States

University of Arkansas Medical School, Little Rock, Arkansas

University of California - Los Angeles, Los Angeles, California

UCSF, San Francisco, California

SCRI at HealthOne, Denver, Colorado

Florida Cancer Specialists & Research Institute, Lake Mary, Florida