NCT05430386

Study of HS-10241 in Combination With Almonertinib in Patients With Locally Advanced or Metastatic NSCLC

A Phase Ib Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10241 in Combination With Almonertinib in Patients With Locally Advanced or Metastatic NSCLC.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted to determine the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-10241 when given together with Almonertinib in patients with EGFRm+ advanced NSCLC.

Detailed description

This is a phase Ⅰb, multicenter study to evaluate safety, tolerability, pharmacokinetics, and efficacy of HS-10241 administered orally in combination with Almonertinib in patients with EGFRm+ locally advanced or metastatic NSCLC who have progressed following prior EGFR-TKI therapy. The study consist of two parts: Part 1 is the dose escalation period to observe the safety, tolerance, PK characteristics and preliminary anti-tumor activity, and determine the maximum tolerated dose (MTD) or maximum applicable dose (MAD) of combined administration; Part 2 is the dose expansion period to select appropriate doses in different target populations and further evaluate the efficacy, safety, tolerance and PK characteristics of combined administration, and determine the phase II recommended dose (RP2D). All patients will be carefully followed for adverse events during the study treatment and for 28 days after the last dose of study drug. Patients of this study will be permitted to continue therapy with assessments for progression once every 8 weeks, if the product is well tolerated and the subject has stable disease or better. Survival follow-up is recommended once every 12 weeks.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HS-10241	Dose escalation: HS-10241 and Almonertinib will be administered in combination. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression. Dose expansion: HS-10241 and Almonertinib will be administered in the dose identified in Part 1 to further investigate the safety, tolerability, pharmacokinetics, and efficacy of this combination therapy.

Timeline

• Start date: 2022-01-05
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-06-24
• Last updated: 2023-02-14

Locations

1 site across 1 country: China