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Tyrosine Kinase Inhibitor

HS-10296 for Non-Small Cell Lung Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of enrollment until the date of death from any cause, approximately 48 months
Awards & highlights

Study Summary

This trial is testing a new drug, HS-10296, as a possible treatment for non-small-cell lung cancer (NSCLC) that has progressed after previous treatment with an EGFR tyrosine kinase inhibitor (TKI) agent. The trial will assess the safety, tolerability, pharmacokinetics, and anti-tumor activity of HS-10296 given orally once daily. The trial will have three phases: dose escalation, dose expansion, and extension cohort.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of enrollment until the date of death from any cause, approximately 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of enrollment until the date of death from any cause, approximately 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and Severity of Adverse Events (AEs) Phase I Part
Number of Participants With Dose Limiting Toxicity (DLT) Phase I Part
Overall Response Rate (ORR) Phase II Part
Secondary outcome measures
AUCss of HS-10296 and HAS-719 After Multiple Dose of HS-10296
Area Under the Plasma Concentration Versus Time Curve (AUC) of HS-10296 and HAS-719 From Zero to the 24-Hour Sampling Time (AUC0-24) After Single Dose of HS-10296
Css Max of HS-10296 and HAS-719 After Multiple Dose
+8 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: Phase 2 ExtensionExperimental Treatment1 Intervention
Oral Once-Daily Administration of HS-10296 110mg (RP2D)
Group II: Expansion Cohort 3Experimental Treatment1 Intervention
Oral Once-Daily Administration of HS-10296 220mg
Group III: Expansion Cohort 2Experimental Treatment1 Intervention
Oral Once-Daily Administration of HS-10296 110mg
Group IV: Expansion Cohort 1Experimental Treatment1 Intervention
Oral Once-Daily Administration of HS-10296 55mg
Group V: Escalation Cohort 4Experimental Treatment1 Intervention
Oral Once-Daily Administration of HS-10296 260mg
Group VI: Escalation Cohort 3Experimental Treatment1 Intervention
Oral Once-Daily Administration of HS-10296 220mg
Group VII: Escalation Cohort 2Experimental Treatment1 Intervention
Oral Once-Daily Administration of HS-10296 110mg
Group VIII: Escalation Cohort 1Experimental Treatment1 Intervention
Oral Once-Daily Administration of HS-10296 55mg

Find a Location

Who is running the clinical trial?

Jiangsu Hansoh Pharmaceutical Co., Ltd.Lead Sponsor
95 Previous Clinical Trials
19,385 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Thoracic OncologyJournal
Safety, Efficacy, and Pharmacokinetics of Almonertinib (HS-10296) in Pretreated Patients with Egfr-mutated Advanced NSCLC: A Multicenter, Open-label, Phase 1 Trial
Yang, James Chih-Hsin, D. Ross Camidge, Cheng-Ta Yang, Jianying Zhou, Renhua Guo, Chao-Hua Chiu, Gee-Chen Chang, et al.. 2020. “Safety, Efficacy, and Pharmacokinetics of Almonertinib (HS-10296) in Pretreated Patients with Egfr-mutated Advanced NSCLC: A Multicenter, Open-label, Phase 1 Trial”. Journal of Thoracic Oncology. Elsevier BV. doi:10.1016/j.jtho.2020.09.001.
clinicaltrials.govStudy
A Study to Evaluate Safety, PK and Efficacy of HS-10296 in Patients With NSCLC
2017. "A Study to Evaluate Safety, PK and Efficacy of HS-10296 in Patients With NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02981108.
~46 spots leftby Apr 2025
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