RecruitingPhase 1NCT06225804

A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer

A Phase 1, Open-Label Study of ABSK112 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Non-Small Cell Lung Cancer


Sponsor

Abbisko Therapeutics Co, Ltd

Enrollment

164 participants

Start Date

Feb 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK112 in patients with NSCLC to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing the safety, tolerability, and appropriate dosing of ABSK112, an experimental oral drug, in people with advanced non-small cell lung cancer (NSCLC). A specific group of interest is patients whose cancer has a type of EGFR mutation called an exon 20 insertion. **You may be eligible if...** - You are 18 years old or older - You have locally advanced or metastatic non-small cell lung cancer confirmed by biopsy - Your cancer has progressed after standard treatment, or you have no other treatment options - In the expansion phase: your tumor has a documented EGFR exon 20 insertion mutation - Your cancer is measurable on imaging - Your overall health status is acceptable (ECOG 0–1) - Your blood pressure is adequately controlled **You may NOT be eligible if...** - You have a specific EGFR mutation called C797S - You have had another primary cancer (with some exceptions) - You are pregnant or breastfeeding - You are unable to use effective contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABSK112

In the escalation part, patients will receive a single dose of oral ABSK112 on Cycle1 Day1 only, and then patients will continuously receive ABSK112 once daily (QD) or twice daily (BID) in subsequent cycles. In the expansion part, patients will each be treated at the selected RDE dose level.


Locations(14)

Precision NextGen Oncology

Beverly Hills, California, United States

Anhui Chest Hospital

Hefei, Anhui, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The first Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Harbin, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huzhong University of Science and Techology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The first Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

Central Hospital Affiliated to Shangdong of First Medical University

Jinan, Shandong, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Zhejiang Caner Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06225804


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