HS-10504 / Jiangsu Hansoh Pharma - LARVOL DELTA

A Pharmacokinetic Study of HS-10504 in Participants With Hepatic Impairment and Normal Hepatic Function. (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial • Hepatology

A Phase I Clinical Trial to Evaluate Pharmacokinetics of HS-10504 (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial

A Mass Balance Study of [14C]HS-10504 (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial

A Phase I Clinical Trial to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10504 (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial

Phase III Study of HS-10504 Versus Platinum-Based Doublet Chemotherapy in Patients With C797S+ NSCLC (clinicaltrials.gov) - P3 | N=206 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

An Open-label, Fixed-sequence Phase I Clinical Trial to Evaluate the Effect of HS-10504 on the Pharmacokinetics of Midazolam in Patients With Non-small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

THE NMPA HAS GRANTED BREAKTHROUGH-THERAPY-DESIGNATED DRUG FOR FOURTH-GENERATION EGFR-TKI HS-10504 TABLETS FOR NSCLC (Hansoh Pharma Press Release) - "Hansoh Pharmaceutical Group Co., Ltd....announced that...HS-10504 tablets has obtained approval to be included as Breakthrough-Therapy-Designated Drug by the National Medical Products Administration (NMPA) of China, with the proposed indication for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the EGFR C797S mutation after prior EGFR-TKI therapy failure...The study results indicated, HS-10504 tablets has demonstrated a promising anti-tumor activity in advanced NSCLC harboring EGFR C797S mutation with the ORR 52.9% and mPFS 9.6 months at the RP2D of 400 mg QD."

Breakthrough therapy • P1 data • Non Small Cell Lung Cancer

The safety, tolerability, and efficacy of HS-10504 in patients with EGFR mutation-positive locally advanced or metastatic NSCLC: Initial results from a first-in-human phase 1 study (AACR 2026) - P1 | "HS-10504 demonstrated a manageable safety profile and encouraging antitumor activity in patients with advanced cancer harboring EGFR C797S resistance mutations, supporting further development of HS-10504 at the selected RP2D and its continued evaluation as a potential oral targeted therapy for EGFR C797S mutation-mediated resistance."

Clinical • First-in-human • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Phase Ib Study of HS-10504 Combined Therapy in NSCLC (clinicaltrials.gov) - P1 | N=400 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC) (clinicaltrials.gov) - P1 | N=230 | Recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Overcoming triple mutant EGFR-tyrosine kinase barriers in the therapeutics of non-small cell lung cancer: a patent review on fourth-generation inhibitors (2017-2024). (PubMed, Expert Opin Ther Pat) - "This review highlights the significance of fourth-generation EGFR tyrosine kinase inhibitors (EGFR-TKIs) in addressing acquired resistance mechanisms, such as the C797S mutation, which compromises the efficacy of third-generation inhibitors like Osimertinib and explores their potential to revolutionize NSCLC treatment through enhanced molecular specificity. Preclinical trials highlight the potential of sulfonyl and phosphine oxide-based compounds for their potency, selectivity, and favorable pharmacokinetics. Promising clinical trials with inhibitors like BDTX-1535, JIN-A02, and HS-10504 could redefine NSCLC treatment, with future success likely relying on innovative strategies, such as combination therapies, to combat resistance and enhance efficacy."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A clinical review on third and fourth generation EGFR tyrosine kinase inhibitors for the treatment of non-small cell lung cancer. (PubMed, Bioorg Med Chem) - "This review delves into the current clinical status, efficacy, safety profiles, and regulatory approvals of third-generation EGFR TKIs, including Osimertinib, Lazertinib, Furmonertinib, Aumolertinib, Rezivertinib, Befotertinib, Sunvozertinib...Notable fourth-generation candidates such as TQB3804, BPI-361175, BDTX-1535, WJ13404, QLH11811, H002, HS-10375, BBT-207, JIN-A02, and HS-10504 are highlighted for their potential to overcome the C797S mutation...By evaluating the therapeutic potential and limitations of these EGFR TKIs, this review aims to guide future research in the management of EGFR-mutant NSCLC. This acts as guiding beacon for the strategic design and development of third and fourth generation EGFR-TK inhibitors to overcome the drug resistance hurdles in the development of EGFR-TK inhibitors."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC) (clinicaltrials.gov) - P1 | N=230 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Metastases • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor