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

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).

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 Cancer
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Related 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 Cancer

Study Overview

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Study Details

Study overview

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).

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

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

Condition
Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Lake Mary

Florida Cancer Specialists & Research Institute, Lake Mary, Florida, United States, 32746

Hackensack

John Theurer Cancer Center at Hackensack UMC, Hackensack, New Jersey, United States, 07601

Nashville

Sarah Cannon Research Institute (SCRI), Nashville, Tennessee, United States, 37203

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Ovarian cancer with CCNE1 amplification
  • 2. Endometrial cancer with CCNE1 amplification
  • 3. Gastric cancer, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification
  • 4. Small cell lung cancer (SCLC)
  • 5. Triple-negative breast cancer (TNBC; human epidermal growth factor receptor 2, estrogen receptor and progesterone receptor negative)
  • 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. Other solid tumors with CCNE1 amplification
  • * Have adequate organ function
  • * Subjects with female reproductive organs must be surgically sterile, post-menopausal, or must be willing to use highly effective method(s) of contraception
  • * Ability to swallow oral medications.
  • * Subjects must consent to provide archived tumor tissues and paired tumor biopsy at pretreatment
  • * Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy.
  • * History of another malignancy with exceptions
  • * History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.
  • * Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)
  • * Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment
  • * Visceral spread with life-threatening complications, lymphangitic spread, known CNS metastases and/or carcinomatous meningitis
  • * Clinically active interstitial lung disease
  • * History of uveitis, retinopathy or other clinically significant retinal disease
  • * Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease
  • * Major surgery within 2 months or minor surgery within 10 days before the first dose of NKT3964.
  • * Has known human immunodeficiency virus (HIV), active hepatitis B or C infection
  • * Prior treatment with a selective or nonselective CDK2 inhibitor
  • * Childs-Pugh class B or C cirrhosis or any other clinically significant liver disorder
  • * Radiation therapy within 4 weeks prior to C1D1

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NiKang Therapeutics, Inc.,

Study Record Dates

2029-05