NTQ1062 / Sino Biopharm - LARVOL DELTA

Deciphering the Medicinal Chemistry Aspects of Akt Inhibitors for the Management of Cancer: Structure-Activity Relationship Frameworks, Landscapes, and Optimization Approaches. (PubMed, Chem Biodivers) - "Special emphasis is given to advanced inhibitors such as capivasertib, ipatasertib, and NTQ1062, which illustrate the influence of pharmacophoric refinement on therapeutic success. In this review, we integrate knowledge of medicinal chemistry and structure to direct the rational design of next generation Akt inhibitors that are safer and more effective for targeted cancer therapy."

Journal • Review • Oncology

AI-assisted molecular docking and molecular dynamics simulations for predicting off-target effects of AKT1 ATP-competitive inhibitors. (PubMed, J Biomol Struct Dyn) - "The results indicate that, in addition to off-target interactions with members of the AGC kinase family predicted for most ATP-competitive inhibitors, Ipatasertib and NTQ1062 may exhibit strong interactions with PI3Kα, a member of the PI3K kinase family, while NTQ1062 may also interact with mTOR, a member of the PI3K-related kinase family. However, further in vitro and in vivo studies are required to validate these potential interactions. Overall, this work establishes a hybrid deep learning and physics-based computational framework for predicting the off-target effects of ATP-competitive AKT1 inhibitors and provides mechanistic insights into kinase cross-reactivity within the PI3K/AKT/mTOR signaling pathway."

Journal • Oncology • PIK3CA

Efficacy and safety of AKT inhibitor NTQ1062 combined with fulvestrant in patients with HR-positive/HER2-negative metastatic breast cancer:a proof-of-concept, multicenter, open-label, nonrandomized, phase Ib/II study. (ASCO 2026) - P1 | "NTQ1062 combined with fulvestrant demonstrated a favorable and manageable safety profile and encouraging clinical activity in patients with HR+/HER2- mBC who had progressed on prior endocrine therapy. Based on superior efficacy and a more favorable tolerability profile observed across dose levels, 200 mg (b.i.d.) was determined to be the OBD of NTQ1062 for the combination with fulvestrant."

Clinical • Metastases • P1/2 data • Breast Cancer • Diabetes • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • AKT1 • HER-2 • PIK3CA • PTEN

Study on the Effect of Food on Healthy Volunteers of NTQ1062 Tablets (ChiCTR) - P=N/A | N=28 | Completed | Sponsor: The Third Xiangya Hospital Central South University; The Third Xiangya Hospital Central South University

New trial • Breast Cancer • Oncology • Solid Tumor

A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov) - P3 | N=210 | Not yet recruiting | Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Phase I Study of NTQ1062 in Chinese Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical | Active, not recruiting ➔ Completed

Metastases • Trial completion • Oncology • Solid Tumor

A Phase Ib/Ⅱ Study of NTQ1062 in Combination With Fulvestrant in Patients With Advanced HR Positive /HER-2 Negative Breast Cancer (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

A Phase I Study of NTQ1062 in Chinese Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical

New P1 trial • Oncology • Solid Tumor

A Phase Ib/Ⅱ Study of NTQ1062 in Combination With Fulvestrant in Patients With Advanced HR Positive /HER-2 Negative Breast Cancer (clinicaltrials.gov) - P1 | N=42 | Not yet recruiting | Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical

New P1 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor