Clinical trial NCT05363280: Phase 2 Safety and Efficacy Evaluation of AL8326 in ≥2nd Line SCLC
Official title: A Phase 2 Evaluation of the Safety and Efficacy of AL8326 in ≥2nd Line Small Cell Lung Cancer (SCLC) Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: Recurrent small cell lung caner
Advanced small cell lung cancer
Metastatic Small lung cancer
≥2nd Line treatment
Lead sponsor: Advenchen Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The phase 2 study aims to find optimal biological dose (OBD) for Phase 2 expansion cohort clinical study. Patients will be randomized to a 3 different dosing daily AL8326 groups ( low. middle. high) in 1:1:1 ratio in OBD finding cohorts.

A phase 2 expansion cohort will be continued if a positive clinical result would have been observed after OBD determination.
Primary purpose: TREATMENT

Brief summary: 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) , to recurrent, advanced, or metastatic small cell lung cancer (SCLC) patients who need ≥2nd line treatment .

Detailed description: This study is designed for two steps: Phase 2 Optimal Biological Dose (OBD) finding and Phase 2 expansion cohort study after OBD determination.

The Phase 2 study aims to find optimal biological dose (OBD) initially. Patients will be randomized to 3 different dosing groups in OBD finding cohorts. Each cohort will enroll 6-12 SCLC patients who need ≥2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage. This OBD finding cohort will also evaluate the pharmacokinetic profile of AL8326.

A phase 2 expansion cohort will be continued if a positive clinical result would have been observed after OBD determination for 40-60 patients. Upon FDA's approval the Phase 2 expansion cohort clinical study will be further expanded to evaluate the safety and efficacy of AL8326 in patients individually with SCLC who need = or \>2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage.

Eligibility criteria: Major Inclusion Criteria:

1. Male or female, 18 years of age or older
2. ECOG performance status of 0 or 1
3. Histologically or cytologically confirmed SCLC
4. Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1
5. Have a life expectancy of at least 3 months

Major Exclusion Criteria:

1. Serious, non-healing wound, ulcer or bone fracture
2. Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment
3. Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
4. Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater congestive heart failure serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease
5. Hemoptysis within 3 months prior to enrollment
6. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life-threatening medical condition that required it.

More information available upon request

Primary outcomes:
measure: Optimal biological dose ( OBD )
timeFrame: 12 months
measure: Objective Response Rates (ORR)
timeFrame: 12 month
Secondary outcomes:
measure: Duration of response ( DOR)
timeFrame: 12 months
measure: Number of participants with AEs, SAEs, abnormal physical examination findings, abnormal laboratory test results, abnormal vital signs and abnormal electrocardiography (ECG) findings
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Saint Louis
country: United States
facility: Siteman Cancer Center, Washington University
state: Missouri
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Washington University School of Medicine
name: Saiama Waqar, MD
role: PRINCIPAL_INVESTIGATOR
References: