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

NCT06586957 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-21

No results posted yet for this study

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).

Conditions

  • Solid Tumor
  • Advanced Solid Tumor
  • Solid Tumor, Adult
  • Metastatic Tumor
  • Ovarian Cancer
  • Ovarian Neoplasms
  • Ovarian Carcinoma
  • Metastatic Ovarian Carcinoma
  • Endometrial Neoplasms
  • Endometrial Diseases
  • Metastatic Endometrial Cancer
  • Triple Negative Breast 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 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

NKT3964

Oral CDK2 Degrader

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
2024-09-19
Primary Completion
2029-01-31
Completion
2029-05-31
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 NCT06586957 on ClinicalTrials.gov