Actively Recruiting
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer
Led by Abbisko Therapeutics Co, Ltd · Updated on 2024-03-18
164
Participants Needed
14
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must understand and sign the informed consent form before screening.
- Male or female aged 18 years or older.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC.
- For escalation part (except RDE confirmation), patients must have progressed on, rejected, or be intolerant of standard therapy or have no standard therapy available.
- For RDE confirmation and expansion parts, patients must have documented EGFR exon 20 insertion mutations confirmed by certified local laboratories.
- At least one measurable target lesion according to RECIST v1.1.
- ECOG performance status of 0 or 1.
- Life expectancy of 3 months or more.
- Adequate organ and bone marrow function.
- Electrolyte levels within specified institutional normal limits.
- Controlled blood pressure (≤150/90 mmHg) with no recent medication changes.
- For food effect exploration, ability to eat a standardized high-fat meal within 30 minutes and fast for 10 hours.
- Non-surgically sterilized patients of childbearing potential must agree to use effective birth control during treatment and for 6 months after last dose; vasectomized men must use condoms.
You will not qualify if you...
- Known allergy or hypersensitivity to any component of the study drug.
- NSCLC patients with EGFR Cys797Ser (C797S) mutation.
- Diagnosis of another primary malignancy except certain treated cancers or relapse-free for at least 3 years.
- Unable to swallow capsules or have significant gastrointestinal disorders affecting drug absorption.
- Previous anti-cancer therapy within 4 weeks before treatment start.
- Major surgery within 4 weeks before first dose or unhealed/infected surgical wounds.
- Unresolved toxicities from prior therapies except specified conditions.
- Use of strong CYP3A inhibitors or inducers within 2 weeks before treatment.
- Consumption of certain fruit juices within 3 days before treatment.
- Current spinal cord compression or leptomeningeal disease.
- Impaired cardiac function or significant heart disease.
- Known AIDS-related illness or positive HIV test.
- Active hepatitis B or C infection not controlled by viral load.
- Uncontrolled ascites, pleural or pericardial effusions requiring intervention.
- Current or unresolved pneumonitis or interstitial lung disease.
- Pregnant or breastfeeding women.
- Recent live vaccine administration within 4 weeks.
- Corneal diseases increasing risk of eye toxicity.
- Other significant comorbidities that may affect study compliance or safety.
- Planned major surgery during study treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Precision NextGen Oncology
Beverly Hills, California, United States, 90212
Actively Recruiting
2
Anhui Chest Hospital
Hefei, Anhui, China
Not Yet Recruiting
3
Fujian Cancer Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
4
The first Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Harbin, China
Not Yet Recruiting
5
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Not Yet Recruiting
6
Henan Cancer Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
7
Union Hospital Tongji Medical College Huzhong University of Science and Techology
Wuhan, Hubei, China
Not Yet Recruiting
8
Hunan Cancer Hospital
Changsha, Hunan, China
Not Yet Recruiting
9
The first Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
10
Jilin Cancer Hospital
Changchun, Jilin, China
Not Yet Recruiting
11
Central Hospital Affiliated to Shangdong of First Medical University
Jinan, Shandong, China
Not Yet Recruiting
12
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
13
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Not Yet Recruiting
14
Zhejiang Caner Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
Research Team
Y
Yuan Lu
CONTACT
Y
Yinan Lin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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