AL8326 for Small Cell Lung Cancer

Not currently recruiting at 10 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of AL8326, a new oral treatment for small cell lung cancer that has returned, spread, or not improved with previous treatment. Researchers will divide participants into three groups to receive different doses of AL8326 to determine the best dose for future use. Suitable candidates should have a diagnosis of small cell lung cancer and require a second or later line of treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AL8326 is generally well-tolerated by people with small cell lung cancer. In earlier studies, patients taking AL8326 experienced an acceptable level of side effects, with most not facing severe issues. AL8326 is a Tyrosine Kinase Inhibitor (TKI) that targets specific proteins aiding cancer growth. While most people managed it well, some side effects may still occur. Participants should inform their healthcare team about any changes they notice during the trial. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for small cell lung cancer?

Unlike the standard treatments for small cell lung cancer, which typically include chemotherapy and immunotherapy, AL8326 offers a new approach by targeting the cancer at a molecular level. Researchers are excited about AL8326 because it is orally administered, potentially making it more convenient and less invasive than intravenous treatments. Additionally, this drug is being tested at low, middle, and high doses to find the optimal biologically effective dose, which could maximize efficacy while minimizing side effects. This tailored dosing strategy is promising for providing a more personalized treatment option for patients.

What evidence suggests that AL8326 could be an effective treatment for small cell lung cancer?

Research shows that AL8326 has produced positive results in treating small cell lung cancer (SCLC). Studies have found that most patients tolerate this treatment well. Importantly, AL8326 has improved outcomes for individuals with recurrent or advanced SCLC who have already tried other treatments. This drug targets specific proteins that aid cancer cell growth. Early findings suggest AL8326 could offer a promising option for those needing more treatment choices for SCLC. ^{1 2 3 6 7}

Who Is on the Research Team?

Saiama N. Waqar

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.8585

Phase Ib/IIa study assessing the safety and efficacy of ... AL8326 has demonstrated acceptable tolerability and positive efficacy on small cell lung cancer treatment.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06247605

A Phase IIII Study of AL8326 in Small Cell Lung Cancer This is a multicenter, randomized, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of AL8326 tablets in small cell lung ...

3. isrctn.com isrctn.com/ISRCTN79004846

AL8326 in advanced Small Cell Lung Cancer To evaluate the overall survival (OS) efficacy of AL8326 tablets as monotherapy in patients with recurrent or advanced small cell lung cancer after second-line ...

4. ascopubs.org ascopubs.org/doi/pdf/10.1200/JCO.2023.41.16_suppl.8585

LUNG CANCER—NON–SMALL CELL ... Conclusions: AL8326 has demonstrated acceptable tolerability and positive efficacy on small cell lung cancer treatment. A US Phase 2 (NCT05363280) study is ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05363280

Phase 2 Safety and Efficacy Evaluation of AL8326 in ≥2nd ... This trial is a Phase II trial designed to evaluate the safety and efficacy of using oral AL8326 , a multi-targeted receptor Tyrosine Kinase Inhibitor( TKI) , ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04890795

A Phase Ib / IIA Study of AL8326 in Small Cell Lung Cancer Objective to evaluate the safety and tolerability of al8326 monotherapy in patients with small cell lung cancer (SCLC) without disease progression (PR or CR or ...

7. clinicaltrials.eu clinicaltrials.eu/inn/al8326/

Al8326 – Application in Therapy and Current Clinical ... Phase I Study: This trial is testing AL8326 in patients with advanced solid tumors to determine the safe dosage and observe any side effects. Phase Ib/IIa Study ...