NKT3447 / NiKang Therap - LARVOL DELTA

NKT3447-101: A Study with NKT3447 for Adults with Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=90 | Active, not recruiting | Sponsor: NiKang Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Endometrial Cancer • Gastric Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

NKT3447-101: A Study with NKT3447 for Adults with Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: NiKang Therapeutics, Inc. | Trial completion date: May 2025 ➔ Mar 2027 | Trial primary completion date: Mar 2025 ➔ Nov 2025

Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Gastric Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

NiKang Therapeutics Doses First Patient in a Phase 1/1b Study of NKT3447, an Oral, Selective Inhibitor of CDK2 Which Reduces Cyclin E Expression (Businesswire) - "The Company announced today that the first patient has been dosed in a phase 1/1b, open-label, first-in-human dose escalation and expansion study of single agent NKT3447, a small molecule that inhibits cyclin-dependent kinase 2 (CDK2). NKT3447 is designed to treat patients with cancers driven by cyclin E amplification or overexpression, which is present in many different tumor types."

Trial status • Oncology • Solid Tumor

Discovery of a selective slow-off CDK2 inhibitor NKT3447 with distinct features of suppressing pCDK2, downregulating cyclin E, and achieving prolonged pathway inhibition (AACR 2024) - "In addition, the combination of NKT3447 with carboplatin exhibits enhanced anticancer effects in OVCAR3 and MFE-280 models. These results demonstrate that NKT3447 is a potent, selective CDK2 inhibitor with distinct properties and mechanism of action, which holds great potential to effectively treat patients with aberrant CDK2/Cyclin E activation in a variety of cancer types. NKT3447 is currently being investigated in a Phase 1 clinical trial in patients with advanced solid tumors."

Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CCNA2 • CCNB1 • CCNE1 • CDK1

NKT3447-101: A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: NiKang Therapeutics, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: May 2027 ➔ May 2025 | Trial primary completion date: Jan 2027 ➔ Mar 2025

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

NiKang Therapeutics Presents the Discovery and Unique Mechanism of Action of a Selective CDK2 Inhibitor NKT3447 at AACR Annual Meeting 2024 (Businesswire) - "NiKang Therapeutics Inc...announced today the unveiling of NKT3447 at the American Association for Cancer Research (AACR) Annual Meeting 2024. NKT3447 is an orally bioavailable small molecule CDK2 inhibitor that exhibits high selectivity against CDK1 and other CDKs, prolonged pharmacodynamic effects, and a distinct mechanism of action. It downregulates cyclin E and suppresses activating phosphorylation of CDK2 on Thr160."

Preclinical • Oncology • Solid Tumor

A Phase 1, First-in-Human Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: NiKang Therapeutics, Inc.

Metastases • New P1 trial • Breast Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer