A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 26, 2026 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Abbisko Therapeutics Co, Ltd
- Interventions being studied
- Drug: ABSK112
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
1. Patients should understand, sign, and date the written informed consent form prior to screening. 2. Male or female aged 18 years or older. 3. Patients with histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NSCLC. 4. Cohort-specific inclusion criteria: 1. For the escalation part (except for the RDE confirmation part), patients have progressed on, rejected, or are intolerant of standard therapy, or for whom no standard therapy exists 2. For RDE confirmation in the escalation part: same as Cohort 1 in the expansion part 3. For the expansion part, patients have documented EGFR in-frame exon 20 insertion mutations confirmed by certificated local laboratories; and must also meet all criteria for the cohort in which their entry is proposed. 5. Patients must have at least one measurable target lesion according to RECIST v1.1 6. ECOG performance status 0 or 1 7. 7\. Life expectancy ≥3 months 8. Adequate organ function and bone marrow function. 9. Electrolyte: magnesium within 0.85 to 1.25 × institutional normal limits, sodium ≥130 mmol/L, potassium within institutional normal limits 10. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Cycle1 Day1. 11. For patients participating in food effect exploration part: 1. Be able to eat a standardized high-fat meal within 30 minutes 2. Be able to fast for 10 hours. 12. Non-surgically sterilized male or female patients of childbearing potential must agree to use highly effective methods of birth control during the study treatment and for approximately 6 months after the last dose of study drug. A condom is also required to be used by vasectomized men to prevent delivery of the drug via seminal fluid.
1. Known allergy or hypersensitivity to any component of the investigational product. 2. NSCLC patients with EGFR Cys797Ser (C797S) mutation. 3. Cohort-specific
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Precision NextGen OncologyBeverly Hills, California
- Anhui Chest HospitalHefei, Anhui
- Fujian Cancer HospitalFuzhou, Fujian
- The first Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, Harbin
- Harbin Medical University Cancer HospitalHarbin, Heilongjiang
- Henan Cancer HospitalZhengzhou, Henan
- Union Hospital Tongji Medical College Huzhong University of Science and TechologyWuhan, Hubei
- Hunan Cancer HospitalChangsha, Hunan
- The first Affiliated Hospital of Nanchang UniversityNanchang, Jiangxi
- Jilin Cancer HospitalChangchun, Jilin
- Central Hospital Affiliated to Shangdong of First Medical UniversityJinan, Shandong
- Shanghai Chest HospitalShanghai, Shanghai Municipality
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 26, 2026. Always confirm current availability with the study team.