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Tyrosine Kinase Inhibitor

AL8326 for Small Cell Lung Cancer

Phase 2
Recruiting
Led By Saiama Waqar, MD
Research Sponsored by Advenchen Pharmaceuticals, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed SCLC
Male or female, 18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights

Study Summary

This trial is testing a new drug to treat small cell lung cancer that has come back or spread. The goal is to see if it is safe and effective.

Who is the study for?
This trial is for adults over 18 with small cell lung cancer (SCLC) who need second or later line treatment. They should have a life expectancy of at least 3 months, be able to perform daily activities with minimal assistance (ECOG status 0-1), and have measurable cancer lesions. Excluded are those with high bleeding risks, recent hemoptysis, unhealed wounds/fractures, major surgery within the past month, serious heart conditions, or using certain drugs affecting liver enzymes.Check my eligibility
What is being tested?
The trial tests three different doses of AL8326 oral medication on patients with recurrent or advanced SCLC. AL8326 is a multi-targeted receptor Tyrosine Kinase Inhibitor (TKI). The goal is to find out how safe it is and how well it works in controlling the disease after first-line treatments haven't worked.See study design
What are the potential side effects?
While specific side effects for AL8326 aren't listed here, similar medications often cause fatigue, nausea, diarrhea, blood pressure changes and risk of bleeding. Side effects can vary based on dose and individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed as small cell lung cancer through testing.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rates (ORR)
Optimal biological dose ( OBD )
Secondary outcome measures
Duration of response ( DOR)
Number of participants with AEs, SAEs, abnormal physical examination findings, abnormal laboratory test results, abnormal vital signs and abnormal electrocardiography (ECG) findings

Trial Design

3Treatment groups
Experimental Treatment
Group I: OBD finding cohort at middle doseExperimental Treatment1 Intervention
Subject in middle dose group will receive AL8326 orally in each cycle until intolerable toxicity or disease progression or withdrawal . 6-12 subjects are in this group. Efficacy, safety and PK will be evaluated and compared within 3 different dosing group to define the final OBD.
Group II: OBD finding cohort at low doseExperimental Treatment1 Intervention
Subject in low dose group will receive AL8326 orally in each cycle until intolerable toxicity or disease progression or withdrawal . 6-12 subjects are in this group. Efficacy, safety and PK will be evaluated and compared within 3 different dosing group to define the final OBD.
Group III: OBD finding cohort at high doseExperimental Treatment1 Intervention
Subject in high dose group will receive AL8326 orally in each cycle until intolerable toxicity or disease progression or withdrawal . 6-12 subjects are in this group. Efficacy, safety and PK will be evaluated and compared within 3 different dosing group to define the final OBD.

Find a Location

Who is running the clinical trial?

Advenchen Pharmaceuticals, LLC.Lead Sponsor
Saiama Waqar, MDPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
23 Total Patients Enrolled
Ramaswamy Govindan, MDPrincipal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
10,758 Total Patients Enrolled

Media Library

AL8326 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05363280 — Phase 2
Small Cell Lung Cancer Research Study Groups: OBD finding cohort at low dose, OBD finding cohort at middle dose, OBD finding cohort at high dose
Small Cell Lung Cancer Clinical Trial 2023: AL8326 Highlights & Side Effects. Trial Name: NCT05363280 — Phase 2
AL8326 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05363280 — Phase 2

Frequently Asked Questions

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

How many participants are accepted into this experiment?

"Affirmative. Evidence from clinicaltrials.gov shows that the medical study, which was launched on November 1st 2022, is currently enrolling participants. 36 people are sought for recruitment across 2 sites."

Answered by AI

Is this clinical research actively looking for participants?

"Affirmative. Clinicaltrials.gov indicates that the trial, initially posted on November 1st 2022, is currently recruiting patients and plans to enroll 36 subjects across two sites."

Answered by AI

Has AL8326 received governmental authorization for use in high doses?

"Due to the absence of evidence for AL8326's efficacy, our team assigned it a safety rating of 2 on a scale from 1-3. This is because this is currently still in Phase 2, presenting only some data supporting its safety."

Answered by AI
~12 spots leftby Dec 2024