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

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

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 .

Study Overview

• Status: Recruiting
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: AL8326 low dose group; Drug: AL8326 middle dose group; Drug: AL8326 high dose group

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shiying Sprinzl; Phone Number: 805-530-1550; Email: shiyings@advenchen.com
• Study Contact Backup: Name: Judy Chen; Phone Number: 805-530-1550; Email: Judyc@advenchen.com

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Recruiting
      • Cleveland Clinic Florida
      • Contact: Phone Number: 954-659-5840
      • Principal Investigator: Evan Alley, MD
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Recruiting
      • Northwestern University
      • Principal Investigator: Jyoti Patel, MD
      • Contact: Study Coordinator; Phone Number: 312-695-0990; Email: cancer@northwetern.edu
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Recruiting
      • Siteman Cancer Center, Washington University
      • Contact: Phone Number: 800-600-3606
      • Contact: Phone Number: 314-747-7222; Email: Patient_Care_Coordination_Center@bjc.org
      • Principal Investigator: Saiama Waqar, MD
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Principal Investigator: Nathan Pennell, MD, PhD
      • Contact: Cancer Answer Line (Taussig); Phone Number: 216-444-7923

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OBD finding cohort at low dose; 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.	Drug: AL8326 low dose group; Taken AL3826 at low dose orally
Experimental: OBD finding cohort at middle dose; 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.	Drug: AL8326 middle dose group; Taken AL3826 at middle dose orally
Experimental: OBD finding cohort at high dose; 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.	Drug: AL8326 high dose group; Taken AL3826 at high dose orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Objective Response Rates (ORR)	Evaluate the efficacy among 3 different dosing groups	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of participants with AEs, SAEs, abnormal physical examination findings, abnormal laboratory test results, abnormal vital signs and abnormal electrocardiography (ECG) findings		12 months

Collaborators and Investigators

• Sponsor: Advenchen Pharmaceuticals, LLC.
• Investigators: Principal Investigator: Saiama Waqar, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Recurrent small cell lung caner; Advanced small cell lung cancer; Metastatic Small lung cancer; ≥2nd Line treatment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: AL8326-US-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No