RecruitingPhase 1NCT06586957

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

A Phase 1, First-in-human, Open-label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral CDK2 Degrader NKT3964 in Adults With Advanced/Metastatic Solid Tumors

Sponsor

NiKang Therapeutics, Inc.

Enrollment

150 participants

Start Date

Sep 19, 2024

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Ovarian Carcinoma Advanced Solid Tumor Ovarian Neoplasms Metastatic Tumor Metastatic Ovarian Carcinoma Solid Tumor Metastatic Endometrial Cancer Solid Tumor, Adult Endometrial Neoplasms Endometrial Diseases

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new experimental drug called NKT3964 in patients with various advanced solid tumors that have not responded to prior treatments. The study will test NKT3964 both alone and in combination with other cancer therapies to determine safe dosing and early signs of effectiveness. **You may be eligible if...** - You have a confirmed advanced, inoperable, or metastatic solid tumor - Your cancer has progressed after standard treatment - You have one of the specific cancer types listed in the study (including ovarian, endometrial, colorectal, pancreatic, or other cancers depending on the study part) - Your overall health and organ function meet the study criteria **You may NOT be eligible if...** - You have active untreated brain metastases - You have serious autoimmune conditions - You are pregnant or breastfeeding - You have had certain prior therapies that disqualify you for specific combination arms - You have significant heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNKT3964

Oral CDK2 Degrader

Locations(19)

University of Arkansas Medical School

Little Rock, Arkansas, United States

University of California - Los Angeles

Los Angeles, California, United States

UCSF

San Francisco, California, United States

SCRI at HealthOne

Denver, Colorado, United States

Florida Cancer Specialists & Research Institute

Lake Mary, Florida, United States

AdventHealth Cancer Institute

Orlando, Florida, United States

Emory Winship Cancer Institute

Atlanta, Georgia, United States

Augusta University

Augusta, Georgia, United States

University of Kansas

Fairway, Kansas, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

John Theurer Cancer Center at Hackensack UMC

Hackensack, New Jersey, United States

Sidney Kimmell Cancer Center - Jefferson Health

Philadelphia, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

Sarah Cannon Research Institute (SCRI)

Nashville, Tennessee, United States

NEXT Oncology

Austin, Texas, United States

UT Southwestern

Dallas, Texas, United States

Intermountain Health

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

NEXT Virginia

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06586957

Related Trials

A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)

NCT0731855828 locations

Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors

NCT0621891418 locations

The Vanguard Study: Testing a New Way to Screen for Cancer

NCT0699589837 locations

DESTINY-PANTUMOUR04

NCT0712400017 locations

NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors

NCT074893781 location