NKT5097 / NiKang Therap - LARVOL DELTA

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=205 | Recruiting | Sponsor: NiKang Therapeutics, Inc.

New P1 trial • Breast Cancer • Carcinosarcoma • Endometrial Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • Uterine Cancer

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=361 | Recruiting | Sponsor: NiKang Therapeutics, Inc. | N=205 ➔ 361

Enrollment change • First-in-human • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Discovery of NKT5097: a first-in-class, highly potent and selective, orally bioavailable CDK2/4 dual degrader for cancer therapy (SABCS 2025) - "NKT5097 also demonstrates a 68-fold increase in selectivity for CDK2 over CDK1 in comparison to PF-07104091, and a 33-fold increase in selectivity for CDK4 over CDK6 compared to PF-07220060 in functional cellular assays...Additionally, combination of NKT5097 with fulvestrant leads to deeper degradation of CDK2 and CDK4 in vitro, resulting in better tumor growth inhibition in HR+ breast cancer models...Therefore, as the first-in-class CDK2/4 dual degrader, NKT5097 presents a unique opportunity to serve as a backbone therapy for HR+HER2- breast cancer and other cancers with CDK2 and/or CDK4 dysregulation. NKT5097 is currently being investigated in a phase I clinical study."

Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • CCNE1 • CDK1 • CDK2 • CDKN2A • HER-2

NiKang Therapeutics…announced the presentation of detailed preclinical data on NKT5097 at the 2025 San Antonio Breast Cancer Symposium (SABCS 2025) (Businesswire) - "NiKang has initiated a Phase 1, open-label, dose escalation study of NKT5097 as a single agent. This first-in-human study (NCT07029399) is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of NKT5097 in patients with advanced or metastatic solid tumors, with a focus on breast cancer and tumors with CCNE1 amplification....'Our research has centered on designing a molecule that selectively degrades CDK2 and CDK4 while sparing CDK1, CDK6, CDK7, and CDK9, with the goal of significantly reducing the gastrointestinal and hematologic toxicities associated with currently approved CDK4/6 inhibitors and addressing emerging resistance mechanism'."

First-in-human • Preclinical • Trial status • Breast Cancer

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=205 | Recruiting | Sponsor: NiKang Therapeutics, Inc. | Initiation date: Jun 2025 ➔ Mar 2025

First-in-human • Trial initiation date • Breast Cancer • Carcinosarcoma • Endometrial Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • Uterine Cancer