Phase 2 Study of AL8326 for Advanced Lung or Kidney Cancer

This study is testing a drug called AL8326 for people with small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), or renal cell carcinoma (RCC, a type of kidney cancer) that has returned or spread, and who have already finished their first treatment. AL8326 is a type of medicine called a tyrosine kinase inhibitor, which works by blocking certain signals that help cancer cells grow. The study aims to find the best dose of AL8326 and see how well it works. You might be able to join if you are 18 or older, have one of these cancer types confirmed by a doctor, and have at least one measurable tumor. The study is currently unclear on its recruitment status, but it plans to enroll 80 participants.

Study design
This is a Phase 2 interventional study designed to find the optimal biological dose of AL8326. It involves randomizing participants to different dosing groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate optimal biological dose and objective response rates for 12 months, and for NSCLC and RCC, objective response rates will be evaluated for 24 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.

NCT05363280

Phase 2 Study for the Patient, Who Has Diagnosed With Small Cell Lung Cancer (SCLC) or Non Small Cell Lung Cancer (NSCLC) or Renal Cell Carcinoma (RCC) and Finished the First Line Stand Treatment , Need More Treatment

Recruiting
PHASE2Ages 18+InterventionalTreatment
Advenchen Pharmaceuticals, LLC.
~80 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:AL8326 40 mgAL8326 60 mgAL8326 80 mg--stopped

At a glance

Recruiting sites
5 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Optimal biological dose ( OBD )
Measured over 12 months
+2 more outcomes measured
Small Cell Lung Cancer
Renal Cell Carcinoma (RCC)
Non-Small Cell Lung
7 sites across 6 states
Spain2
Alabama1
Florida1
Illinois1
Missouri1
Ohio1
  • Saiama Waqar, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

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  • Optimal biological dose ( OBD )12 months

    Determine the Optimal biological dose ( OBD ) via evaluation of dose limiting toxicity (DLT) events to decide the dosing using in expanded cohort

  • Objective Response Rates (ORR)12 month

    Evaluate the efficacy among 3 different dosing groups

  • ORR evaluation for NSCLC and RCC24 month

    ORR evaluation for NSCLC and RCC