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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Abbisko Therapeutics Co, Ltd
Study ID
NCT06225804
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABSK112 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 22, 2024
Status verified
Mar 2024
Primary completion
Mar 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
164 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ABSK112
    During the escalation part, the administration of oral ABSK112 will be guided by Bayesian optimal interval (BOIN) design based on safety data collected until a maximum tolerated dose (MTD) has been identified. The first dose level will be administered as QD, and different dosing frequencies (e.g., BID) may be explored in subsequent doses depending on emerging safety and pharmacokinetic data. A separate food effect cohort may be conducted. In expansion part, patients will be treated at the selected RDE dose level.

Primary Outcome Measure

Incidence of DLT [ Time Frame: from Day1 to Day28 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Precision NextGen OncologyBeverly HillsCalifornia90212
Kamlesh Sankhala, MD
Kamlesh Sankhala, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Beverly Hills, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Precision NextGen Oncology· Beverly Hills, CA

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