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TerminatedPhase 1NCT06264921
Official study title

A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors

Study summary

The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor activity of NKT3447 in adult subjects with cyclin E1 (CCNE1) amplified ovarian cancer at the RDEs selected in Dose Escalation and to determine the preliminary recommended phase 2 dose (RP2D).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNKT3447

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Metastatic or stage IV · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 25, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?NiKang Therapeutics, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
NiKang Therapeutics, Inc.
Interventions being studied
Drug: NKT3447
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
Disease setting
Metastatic or stage IV→Resistant or refractory→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
  • Sarah Cannon Research Institute at HealthONEDenver, Colorado
  • AdventHealth Cancer InstituteCelebration, Florida
  • Augusta University Georgia Cancer CenterAugusta, Georgia
  • Norton Cancer Institute - BroadwayLouisville, Kentucky
  • The Gabrail Pharmacology Phase 1 Research CenterCanton, Ohio
  • Texas Oncology-Austin Midtown NEXT OncologyAustin, Texas
  • START Mountain RegionWest Valley City, Utah

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 25, 2025. Always confirm current availability with the study team.

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