Phase 2 Safety and Efficacy Evaluation of AL8326 in ≥2nd Line SCLC

Small Cell Lung Cancer Clinical Trial

Official title:

A Phase 2 Evaluation of the Safety and Efficacy of AL8326 in ≥2nd Line Small Cell Lung Cancer (SCLC) Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05363280
• Other study ID #: AL8326-US-001
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Advenchen Laboratories, LLC
• Contact: Shiying Sprinzl
• Phone: 805-530-1550
• Email: shiyings[@]advenchen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• AL8326 low dose group
Taken AL3826 at low dose orally
• AL8326 middle dose group
Taken AL3826 at middle dose orally
• AL8326 high dose group
Taken AL3826 at high dose orally

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	Northwestern University	Evanston	Illinois
United States	Siteman Cancer Center, Washington University	Saint Louis	Missouri
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Advenchen Pharmaceuticals, LLC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal biological dose ( OBD )	Determine the Optimal biological dose ( OBD ) via evaluation of dose limiting toxicity (DLT) events to decide the dosing using in expanded cohort	12 months
Primary	Objective Response Rates (ORR)	Evaluate the efficacy among 3 different dosing groups	12 month
Secondary	Duration of response ( DOR)	Measure the length of time that a tumor continues to respond to treatment without the cancer growing or spreading	12 months
Secondary	Number of participants with AEs, SAEs, abnormal physical examination findings, abnormal laboratory test results, abnormal vital signs and abnormal electrocardiography (ECG) findings		12 months