What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy agents like cisplatin and pemetrexed can cause side effects such as nausea, fatigue, hair loss, and increased risk of infection. Targeted therapies, such as tyrosine kinase inhibitors (e.g., erlotinib, gefitinib), often lead to rash, diarrhea, and liver function abnormalities. Immunotherapies, including checkpoint inhibitors like pembrolizumab and nivolumab, may result in immune-related side effects such as colitis, pneumonitis, and thyroid dysfunction. Novel agents like ABSK112, while still under investigation, are expected to have side effects that may include fatigue, nausea, and liver function changes, similar to other targeted therapies.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC), particularly focusing on novel therapeutic agents and combination regimens. Pembrolizumab, an anti-PD-1 therapy, has been approved for use in combination with chemotherapy for advanced NSCLC. Atezolizumab, another immunotherapy agent, has been approved in combination with bevacizumab, carboplatin, and paclitaxel (ABCP regimen) for patients with advanced nonsquamous NSCLC. These approvals highlight the trend towards combining immunotherapy with traditional chemotherapy to enhance treatment efficacy, similar to the approach being studied with ABSK112.

What other types of research exist?

Promising alternatives to ABSK112 for NSCLC patients include MB02 (a bevacizumab biosimilar) in combination with carboplatin and paclitaxel, which has demonstrated similar efficacy and safety to EU-bevacizumab. Additionally, immune checkpoint inhibitors such as nivolumab, atezolizumab, and pembrolizumab have shown significant efficacy in previously treated NSCLC patients. Personalized, genotype-directed therapies like trastuzumab deruxtecan for HER2-overexpressing NSCLC and KRASG12C inhibitors like sotorasib and adagrasib are also promising options.

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Monoclonal Antibodies

ABSK112 for 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

Must not have

Major surgery within 4 weeks prior to the first dose of study drug. Or any surgical wound is infected, dehisced, or not completely healed before the screening

Current evidence or previous history of corneal pathology such as keratopathy, corneal abrasion or ulceration, or any other abnormal changes that may increase the risk of corneal toxicity during the study treatment

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

No Placebo-Only Group

Summary

This trial is testing ABSK112, a new drug, in patients with advanced lung cancer that has a specific genetic mutation. The goal is to see if the drug is safe and if it can help stop the cancer from growing.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery in the last 4 weeks and my surgical wounds are healed.

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I have had eye problems like corneal damage or changes that could worsen with treatment.

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I am scheduled for a major surgery during the study.

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I have spinal cord compression or leptomeningeal disease, with or without symptoms.

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I have heart problems that affect my daily activities.

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I have AIDS or tested positive for HIV.

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My NSCLC has a specific EGFR mutation.

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I have lung issues from past treatments or conditions that needed steroids.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AESIs

AEs

Incidence of DLT

+1 more

Secondary study objectives

AUC

AUCtau,ss

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as EGFR and ALK inhibitors, specifically inhibit the activity of mutated proteins that drive cancer growth. Immunotherapies, like PD-1/PD-L1 inhibitors, boost the immune system's ability to recognize and destroy cancer cells. Chemotherapy works by killing rapidly dividing cells, including cancer cells. The novel agent ABSK112, under investigation, likely represents a new class of targeted therapy or immunotherapy, aiming to offer more effective and safer treatment options. Understanding these mechanisms is crucial for selecting personalized treatment strategies, potentially improving patient outcomes and minimizing side effects.

Emerging therapeutic agents for lung cancer.