AL8326 for Small Cell Lung Cancer

Recruiting at 6 trial locations

Overseen By Judy Chen

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Advenchen Pharmaceuticals, LLC.

Must not be taking: CYP3A4 inhibitors, CYP2C9 inducers

Disqualifiers: Cardiovascular disease, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the safety and effectiveness of AL8326, a medication taken by mouth, in patients with advanced small cell lung cancer who need additional treatment. The drug works by blocking proteins that help cancer cells grow.

Do I need to stop my current medications for the trial?

The trial requires that you do not take strong inhibitors or inducers of certain enzymes (CYP3A4, CYP2C9, and CYP2C19) within 14 days before starting and during the study, unless it's an emergency. Check with your doctor to see if your current medications fall into this category.

Research Team

Saiama N. Waqar

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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.

Inclusion Criteria

You are expected to live for at least 3 more months.

My cancer is confirmed as small cell lung cancer through testing.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.

I do not have conditions that increase my risk of bleeding significantly.

I have a serious wound, ulcer, or bone fracture that isn't healing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

OBD Finding

Participants are randomized into three dosing groups to determine the optimal biological dose (OBD) of AL8326. Efficacy, safety, and pharmacokinetics are evaluated.

12 months

Expansion Cohort

Following OBD determination, the study expands to evaluate the safety and efficacy of AL8326 in a larger cohort of patients.

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AL8326

Trial Overview 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.

Participant Groups

Group I: OBD finding cohort at middle dose Experimental Treatment 1 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 dose Experimental Treatment 1 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 dose Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Advenchen Pharmaceuticals, LLC.

Lead Sponsor

Trials

1

Recruited

40+