Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

Summary

The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor activity of NKT3447 in adult subjects with cyclin E1 (CCNE1) amplified ovarian cancer at the RDEs selected in Dose Escalation and to 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 Orally Available CDK2 Inhibitor NKT3447 in Adults With Advanced/Metastatic Solid Tumors

Details

Keywords

Solid Tumor, Solid Tumor, Adult, Advanced Solid Tumor, Metastatic Tumor, Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma, Metastatic Ovarian Carcinoma, Endometrial Cancer, Endometrial Neoplasms, Endometrial Diseases, Metastatic Endometrial 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 Cancer, 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, CDK 2 Inhibitor, CDK 4 Inhibitor, CDK 6 Inhibitor, Carcinoma, Neoplasms, Breast Neoplasms, Ovarian Epithelial Carcinoma, Stomach Neoplasms, Neoplasm Metastasis, Uterine Diseases, NKT3447

Eligibility

Locations

  • University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
    San Francisco California 94158 United States
  • START Mountain Region
    West Valley City Utah 84119 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NiKang Therapeutics, Inc.
ID
NCT06264921
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated