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

NCT06264921 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-09-25

No results posted yet for this 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).

Conditions

  • Solid Tumor
  • Solid Tumor, Adult
  • Advanced Solid Tumor
  • Metastatic Tumor
  • Ovarian Cancer
  • Ovarian Neoplasms
  • Ovarian Carcinoma
  • Metastatic Ovarian Carcinoma
  • Endometrial Cancer
  • Endometrial Neoplasms
  • Endometrial Diseases
  • Metastatic Endometrial Cancer
  • Metastatic Endometrial Carcinoma
  • Advanced Endometrial Carcinoma
  • Advanced Ovarian Carcinoma
  • Gastric Cancer
  • Advanced Gastric Carcinoma
  • Metastatic Gastric Cancer
  • Metastatic Gastric Carcinoma
  • Small-cell Lung Cancer
  • Small Cell Lung Carcinoma
  • Triple Negative Breast Cancer
  • Triple Negative Breast Neoplasms
  • Platinum-resistant Ovarian Cancer
  • Platinum-refractory Ovarian Carcinoma
  • CCNE1 Amplification
  • Hormone Receptor Negative Breast Carcinoma
  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  • Progesterone-receptor-positive Breast Cancer

Interventions

DRUG

NKT3447

Oral CDK2 inhibitor

Sponsors & Collaborators

  • NiKang Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-23
Primary Completion
2025-04-07
Completion
2025-04-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06264921 on ClinicalTrials.gov