RECRUITING

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

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Conditions

Solid TumorAdvanced Solid TumorSolid Tumor, AdultMetastatic TumorOvarian CancerOvarian NeoplasmsOvarian CarcinomaMetastatic Ovarian CarcinomaEndometrial NeoplasmsEndometrial DiseasesMetastatic Endometrial CancerTriple Negative Breast CancerMetastatic Endometrial CarcinomaAdvanced Endometrial CarcinomaAdvanced Ovarian CarcinomaGastric CancerAdvanced Gastric CarcinomaMetastatic Gastric CancerMetastatic Gastric CarcinomaSmall Cell Lung CancerSmall Cell Lung CarcinomaTriple Negative Breast NeoplasmsPlatinum-resistant Ovarian CancerPlatinum-refractory Ovarian CarcinomaCCNE1 AmplificationHormone Receptor Negative Breast CarcinomaHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastProgesterone-receptor-positive Breast CancerCDK 2 InhibitorCDK 4 InhibitorCDK 6 Inhibitor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 RDEs based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).

Official Title

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

Quick Facts

Study Start:2024-09-19
Study Completion:2029-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06586957

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ovarian cancer with CCNE1 amplification
  2. 2. Endometrial cancer with CCNE1 amplification
  3. 3. Gastric cancer, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification
  4. 4. Small cell lung cancer (SCLC)
  5. 5. Triple-negative breast cancer (TNBC; human epidermal growth factor receptor 2, estrogen receptor and progesterone receptor negative)
  6. 6. Pathologically confirmed HR+ (includes estrogen-receptor or progesterone-receptor) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BrCa; must have progressed following treatment with a CDK4/6 inhibitor, and is not suitable for endocrine therapy)
  7. 7. Other solid tumors with CCNE1 amplification
  8. * Have adequate organ function
  9. * Subjects with female reproductive organs must be surgically sterile, post-menopausal, or must be willing to use highly effective method(s) of contraception
  10. * Ability to swallow oral medications.
  11. * Subjects must consent to provide archived tumor tissues and paired tumor biopsy at pretreatment
  1. * Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy.
  2. * History of another malignancy with exceptions
  3. * History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.
  4. * Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)
  5. * Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment
  6. * Visceral spread with life-threatening complications, lymphangitic spread, known CNS metastases and/or carcinomatous meningitis
  7. * Clinically active interstitial lung disease
  8. * History of uveitis, retinopathy or other clinically significant retinal disease
  9. * Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease
  10. * Major surgery within 2 months or minor surgery within 10 days before the first dose of NKT3964.
  11. * Has known human immunodeficiency virus (HIV), active hepatitis B or C infection
  12. * Prior treatment with a selective or nonselective CDK2 inhibitor
  13. * Childs-Pugh class B or C cirrhosis or any other clinically significant liver disorder
  14. * Radiation therapy within 4 weeks prior to C1D1

Contacts and Locations

Study Contact

Sponsor Contact
CONTACT
(302) 596-8654
clinicaltrials@nikangtx.com

Study Locations (Sites)

Florida Cancer Specialists & Research Institute
Lake Mary, Florida, 32746
United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, 07601
United States
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, 37203
United States

Collaborators and Investigators

Sponsor: NiKang Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-19
Study Completion Date2029-05

Study Record Updates

Study Start Date2024-09-19
Study Completion Date2029-05

Terms related to this study

Keywords Provided by Researchers

  • CDK 2 Inhibitor
  • CDK 4 Inhibitor
  • CDK 6 Inhibitor

Additional Relevant MeSH Terms

  • 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