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Monoclonal Antibodies

ABSK112 for Non-Small Cell Lung Cancer

Phase 1

Recruiting

Research Sponsored by Abbisko Therapeutics Co, Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NSCLC

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the 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.

Awards & highlights

Study Summary

This trial is testing a new drug called ABSK112 in patients with a type of lung cancer called NSCLC. The trial aims to determine if the drug is safe, well-tolerated,

Who is the study for?

Adults with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have tried other treatments without success, or for whom no standard treatment is available. Participants must be over 18, understand the study and consent to it, have a life expectancy of at least 3 months, and good organ function. Women of childbearing age and men must agree to use effective birth control.Check my eligibility

What is being tested?

ABSK112 is being tested in this phase 1 trial for safety, tolerability, how the body processes it (pharmacokinetics), and initial effectiveness against NSCLC. The study is open-label meaning everyone knows what treatment they're getting; non-randomized so there's no chance element in assigning treatments.See study design

What are the potential side effects?

While specific side effects are not listed here as this is a first-in-human study of ABSK112, common side effects from cancer drugs can include nausea, fatigue, skin reactions, blood count changes leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is advanced and cannot be treated with surgery or radiation alone.

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My cancer has a specific EGFR mutation confirmed by a lab.

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I am fully active or can carry out light work.

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My blood pressure is under control, at 150/90 or lower, without changing my medication in the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the 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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AESIs

AEs

Incidence of DLT

+1 more

Secondary outcome measures

AUC

AUCtau,ss

+12 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ABSK112Experimental Treatment1 Intervention

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.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Abbisko Therapeutics Co, LtdLead Sponsor

18 Previous Clinical Trials

1,139 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for potential participants in this research study?

"Indeed, as per the information available on clinicaltrials.gov, this current clinical trial is actively seeking eligible patients. The initial posting of this trial occurred on January 1st, 2024, with the most recent update made on January 17th, 2024."

Answered by AI

What is the upper limit for the number of participants enrolled in this clinical investigation?

"Indeed, according to the details provided on clinicaltrials.gov, this trial is currently in the recruitment phase. The initial posting of the trial occurred on January 1st, 2024 and it was most recently updated on January 17th, 2024. The study aims to enroll a total of 164 participants from two distinct locations."

Answered by AI

What is the primary goal behind conducting this medical trial?

"The primary goal of this study is to evaluate and monitor adverse events (AEs) over a period of approximately 28 days, starting from Day1. Secondary objectives include assessing Disease Control Rate (DCR), which measures the rate at which the disease is controlled; Progression-Free Survival (PFS), which measures the duration without any disease progression; and apparent volume of distribution (Vz/F), a measure related to drug distribution in the body."

Answered by AI

What is the level of safety associated with ABSK112 when administered to patients?

"Our team at Power has assigned a safety rating of 1 to ABSK112, indicating limited data supporting its safety and efficacy due to it being a Phase 1 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06225804.