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New pill targets Hard-to-Treat cancers in early human test

NCT ID NCT06264921

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested an experimental oral drug called NKT3447 in 23 adults with advanced or metastatic solid tumors that had stopped responding to standard treatments. The goal was to check safety, find the right dose, and see if the drug could shrink tumors. The study was terminated early, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NKT3447 (an oral CDK2 inhibitor)
What this could lead to
If it works, this could point toward a new treatment option for certain advanced solid tumors, especially ovarian cancer with CCNE1 amplification.
What could go wrong
This was a very early (Phase 1) trial with only 23 participants, and it was terminated early. The drug may not prove effective or safe in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

23 people

The number who actually took part.

Started

Feb 2024

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must have confirmed unresectable advanced/metastatic solid tumors (as outlined below) with disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment likely to improve the disease outcome in the judgment of the Investigator. * Measurable disease per the RECIST v1.1 * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Able to swallow oral medications. Dose Escalation(Part 1): 1. Ovarian cancer 2. Endometrial cancer 3. Gastric cancer or gastroesophageal junction cancer 4. Small cell lung cancer (SCLC) 5. Triple-negative breast cancer (human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], progesterone receptor negative) 6. ER/progesterone-receptor positive, HER2 negative breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and not suitable for endocrine therapy) 7. Other solid tumors with CCNE1 amplification as determined by NGS by local liquid or tissue biopsy. Dose Expansion (Part 2): a. Platinum resistant or refractory ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least 1 platinum containing therapy with CCNE1 amplification as determined by NGS by local liquid or tissue biopsy. * Measurable disease per the RECIST v1.1 * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Able to swallow oral medications. Exclusion Criteria: * Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy. * History of another malignancy with exceptions * Visceral crisis with life-threatening complications, lymphangitic spread, CNS metastasis and/or carcinomatous meningitis * Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE) * Clinically active interstitial lung disease * History of uveitis, retinopathy or other clinically significant retinal disease * Has known human immunodeficiency virus (HIV), active hepatitis B or C infection * Prior CDK2 inhibitor * Major surgery within 2 months or minor surgery within 10 days before the first dose of NKT3447

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AdventHealth Cancer Institute

    Celebration, Florida, 34747, United States

  • Augusta University Georgia Cancer Center

    Augusta, Georgia, 30909, United States

  • Norton Cancer Institute - Broadway

    Louisville, Kentucky, 40202, United States

  • START Mountain Region

    West Valley City, Utah, 84119, United States

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218, United States

  • Texas Oncology-Austin Midtown NEXT Oncology

    Austin, Texas, 78758, United States

  • The Gabrail Pharmacology Phase 1 Research Center

    Canton, Ohio, 44718, United States

  • University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158, United States

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