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NCT07029399 · ClinicalTrials.gov registry record · Phase 1

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

A Phase 1 study of Ovarian Cancer and Endometrial Cancer, sponsored by NiKang Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
205
Enrollment target
14
Study locations

NCT07029399 is a Phase 1 study of Ovarian Cancer and Endometrial Cancer that is actively recruiting participants, run by NiKang Therapeutics. The registered enrollment target is 205 participants, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (72% lower). The trial reports 14 study locations across 12 states.

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The verdict

NCT07029399, a Phase 1 study of Ovarian Cancer and Endometrial Cancer, is actively recruiting participants, sponsored by NiKang Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
205 participants
Enrollment target
14
Study locations

Study Summary

The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include: * What is the recommended dose for expansion and/or Phase 2 * What medical issues/symptoms do participants experience when taking NKT5097

Conditions Studied

Ovarian Cancer Endometrial Cancer Triple Negative Breast Cancer (TNBC) Uterine Carcinosarcoma HR+ HER2- Breast Cancer HR+ Breast Cancer CCNE1 Amplified Advanced Solid Tumors

Interventions

  • DRUG NKT5097 CDK2/CDK4 dual degrader

Study Locations (14)

Texas

  • University of Texas Southwestern Medical Center - Dallas
  • MD Anderson Cancer Center - Houston
  • South Texas Accelerated Research Therapeutics (START) San Antonio - San Antonio

California

  • UC San Diego Moores Cancer Center - La Jolla

Colorado

  • Sarah Cannon Research Institute at HealthONE - Denver

Connecticut

  • Yale Cancer Center - New Haven

Florida

  • SCRI Florida Cancer Specialists - Sarasota - Sarasota

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Michigan

  • South Texas Accelerated Research Therapeutics (START) Midwest - Grand Rapids

Missouri

  • Washington University - St Louis

Trial Details

FieldValue
Enrollment Target 205 participants
Start Date 2025-03-25
Est. Completion 2027-12-31
Phase Phase 1

Sponsor

NiKang Therapeutics

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07029399

The ClinicalTrials.gov registry entry for NCT07029399 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 205 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (72% lower). The listed sponsor is NiKang Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention - of which NKT5097 CDK2/CDK4 dual degrader is the first listed.

NCT07029399 reports 14 study locations spanning 12 distinct geographic areas - top geographies include Texas, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT07029399 about?

NCT07029399 is a clinical study titled "A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors". The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include: * What is the recommended dose for...

What is the current status of trial NCT07029399?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 205 participants. The study started on 2025-03-25. Estimated completion is 2027-12-31.

What conditions does trial NCT07029399 study?

This clinical trial studies the following conditions: Ovarian Cancer, Endometrial Cancer, Triple Negative Breast Cancer (TNBC), Uterine Carcinosarcoma, HR+ HER2- Breast Cancer.

What interventions are being tested in trial NCT07029399?

The interventions under investigation include: NKT5097 CDK2/CDK4 dual degrader (DRUG).

Who is sponsoring clinical trial NCT07029399?

This trial is sponsored by NiKang Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07029399 being conducted?

This trial has 14 study locations across California, Colorado, Connecticut, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.