A Phase 1, Open-Label Study of ABSK112 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Non-Small Cell Lung Cancer
Abbisko Therapeutics Co, Ltd
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.
Description
The study will be started with a dose escalation part of ABSK112 administered in repeated 28-day cycles in patients with NSCLC. The expansion part of oral ABSK112 at the recommended dose of expansion (RDE) will be followed to evaluate safety, tolerability, and preliminary antitumor activity among patients with locally advanced or metastatic NSCLC harboring EGFR Exon20ins.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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…
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 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