RecruitingPhase 1

A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors

United States150 participantsStarted 2024-09-19

Plain-language summary

The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Ovarian cancer
✓. Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)
✓. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification
✓. Small cell lung cancer (SCLC)
✓. Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)
✓. HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and is not suitable for endocrine therapy \[ET\])
✓. Other solid tumors with CCNE1 amplification

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 IDNCT06586957

SponsorNiKang Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-01

Contact for this trial

Sponsor Contact

(302) 596-8654 clinicaltrials@nikangtx.com

View on ClinicalTrials.gov More Solid Tumor trials