New pill targets Hard-to-Treat cancers in early human test
NCT ID NCT06264921
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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23 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Apr 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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AdventHealth Cancer Institute
Celebration, Florida, 34747, United States
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Augusta University Georgia Cancer Center
Augusta, Georgia, 30909, United States
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Norton Cancer Institute - Broadway
Louisville, Kentucky, 40202, United States
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START Mountain Region
West Valley City, Utah, 84119, United States
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Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218, United States
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Texas Oncology-Austin Midtown NEXT Oncology
Austin, Texas, 78758, United States
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The Gabrail Pharmacology Phase 1 Research Center
Canton, Ohio, 44718, United States
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University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- First human test of BI 4060107 aims to find safe dose for Hard-to-Treat tumors