TerminatedPhase 1

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

Stopped: This study was terminated as a result of Sponsor portfolio reprioritization.

United States23 participantsStarted 2024-02-23

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Ovarian cancer
✓. Endometrial cancer
✓. Gastric cancer or gastroesophageal junction cancer
✓. Small cell lung cancer (SCLC)
✓. Triple-negative breast cancer (human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], progesterone receptor negative)
✓. ER/progesterone-receptor positive, HER2 negative breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and not suitable for endocrine therapy)
✓. Other solid tumors with CCNE1 amplification as determined by NGS by local liquid or tissue biopsy.

What they're measuring

Number of Participants with Dose Limiting Toxicity (DLT) events

Timeframe: 28 days

Objective Response Rate (ORR)

Timeframe: 1 year

Trial details

NCT IDNCT06264921

SponsorNiKang Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-07

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