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OncoMatch/Clinical Trials/NCT06586957

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

Is NCT06586957 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies NKT3964 for solid tumor.

Phase 1RecruitingNiKang Therapeutics, Inc.NCT06586957Data as of May 2026

Treatment: NKT3964The 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).

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Ovarian Cancer

Endometrial Cancer

Triple-Negative Breast Cancer

Breast Carcinoma

Gastric Cancer

Small Cell Lung Cancer

Biomarker criteria

Required: CCNE1 amplification

CCNE1 amplification

Disease stage

Required: Stage III, IV

Prior therapy

Min 1 prior line

Must have received: standard of care — advanced/metastatic

documented disease progression on last standard treatment

Cannot have received: CDK2 inhibitor

Prior investigative treatment with a selective or nonselective CDK2 inhibitor or degrader

Lab requirements

Blood counts

Kidney function

Liver function

Have adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Arkansas Medical School · Little Rock, Arkansas
  • University of California - Los Angeles · Los Angeles, California
  • UCSF · San Francisco, California
  • SCRI at HealthOne · Denver, Colorado
  • Florida Cancer Specialists & Research Institute · Lake Mary, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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