ABSK112 for Non-Small Cell Lung Cancer

This study is testing a new medication called ABSK112 for people with locally advanced or metastatic non-small cell lung cancer (NSCLC). The main goals are to see how safe ABSK112 is, how well your body handles it, and how it moves through your system. Researchers will also look for early signs that ABSK112 might help fight cancer. You would take ABSK112 either once or twice a day. To join, you need to be at least 18 years old and have NSCLC that has been confirmed by a biopsy. Some participants will specifically have NSCLC with an EGFR Exon20ins biomarker. The study plans to enroll 164 participants, but its current recruitment status is unclear.

Study design
This is a first-in-human, multicenter, non-randomized, open-label study. It will involve a dose escalation part followed by an expansion part.
What's involved
In the escalation part, you would receive a single dose of oral ABSK112 on Day 1 of the first cycle, then continuously receive it once or twice daily in later cycles. In the expansion part, you would be treated at a selected dose level.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for side effects from the time you sign the consent form until 30 days after your last dose of ABSK112, for up to 50 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06225804

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Abbisko Therapeutics Co, Ltd
~164 participants
Updated 2024-03-18 on ClinicalTrials.gov
What's tested:ABSK112

At a glance

Recruiting sites
2 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of DLT
Measured over from Day1 to Day28
+3 more outcomes measured
Non-Small Cell Lung Cancer
14 sites across 14 states
California1
Anhui1
Fujian1
Harbin1
Heilongjiang1
Henan1
Hubei1
Hunan1

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  • Incidence of DLTfrom Day1 to Day28

    Dose-limiting toxicities

  • AEsThe date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 50 months.

    Adverse events

  • AESIsThe date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 50 months.

    Adverse events of special interest (AESIs)

  • SAEsThe date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 50 months.

    Serious adverse events (SAEs)