Back to results

AL8326 in SCLC Treatment

Primary Purpose

Small Cell Lung Cancer

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

AL8326 low dose group

AL8326 middle dose group

AL8326 high dose group

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Recurrent small cell lung caner, Advanced small cell lung cancer, Metastatic Small lung cancer, ≥2nd Line treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Major Inclusion Criteria:

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

Major Exclusion Criteria:

Serious, non-healing wound, ulcer or bone fracture
Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment
Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
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
Hemoptysis within 3 months prior to enrollment
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

Sites / Locations

Northwestern UniversityRecruiting
Siteman Cancer Center, Washington UniversityRecruiting
Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

OBD finding cohort at low dose

OBD finding cohort at middle dose

OBD finding cohort at high dose

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Objective Response Rates (ORR)

Evaluate the efficacy among 3 different dosing groups

Secondary Outcome Measures

Duration of response ( DOR)

Measure the length of time that a tumor continues to respond to treatment without the cancer growing or spreading

Number of participants with AEs, SAEs, abnormal physical examination findings, abnormal laboratory test results, abnormal vital signs and abnormal electrocardiography (ECG) findings

Full Information

NCT ID

NCT05363280

First Posted

April 22, 2022

Last Updated

October 19, 2023

Sponsor

Advenchen Pharmaceuticals, LLC.

1. Study Identification

Unique Protocol Identification Number

NCT05363280

Brief Title

AL8326 in SCLC Treatment

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Advenchen Pharmaceuticals, LLC.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer

Keywords

Recurrent small cell lung caner, Advanced small cell lung cancer, Metastatic Small lung cancer, ≥2nd Line treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

OBD finding cohort at low dose

Arm Type

Experimental

Arm Description

Arm Title

OBD finding cohort at middle dose

Arm Type

Experimental

Arm Description

Arm Title

OBD finding cohort at high dose

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

AL8326 low dose group

Intervention Description

Taken AL3826 at low dose orally

Intervention Type

Drug

Intervention Name(s)

AL8326 middle dose group

Intervention Description

Taken AL3826 at middle dose orally

Intervention Type

Drug

Intervention Name(s)

AL8326 high dose group

Intervention Description

Taken AL3826 at high dose orally

Primary Outcome Measure Information:

Title

Optimal biological dose ( OBD )

Description

Determine the Optimal biological dose ( OBD ) via evaluation of dose limiting toxicity (DLT) events to decide the dosing using in expanded cohort

Time Frame

12 months

Title

Objective Response Rates (ORR)

Description

Evaluate the efficacy among 3 different dosing groups

Time Frame

12 month

Secondary Outcome Measure Information:

Title

Duration of response ( DOR)

Description

Measure the length of time that a tumor continues to respond to treatment without the cancer growing or spreading

Time Frame

12 months

Title

Number of participants with AEs, SAEs, abnormal physical examination findings, abnormal laboratory test results, abnormal vital signs and abnormal electrocardiography (ECG) findings

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Major Inclusion Criteria: Male or female, 18 years of age or older ECOG performance status of 0 or 1 Histologically or cytologically confirmed SCLC Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1 Have a life expectancy of at least 3 months Major Exclusion Criteria: Serious, non-healing wound, ulcer or bone fracture Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels 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 Hemoptysis within 3 months prior to enrollment 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shiying Sprinzl

Phone

805-530-1550

shiyings@advenchen.com

First Name & Middle Initial & Last Name or Official Title & Degree

Judy Chen

Phone

805-530-1550

Judyc@advenchen.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Saiama Waqar, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60208

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

312-695-0990

cancer@northwetern.edu

First Name & Middle Initial & Last Name & Degree

Jyoti Patel, MD

Facility Name

Siteman Cancer Center, Washington University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63130

Country

United States

Individual Site Status

Recruiting

Facility Contact:

Phone

314-747-7222

Patient_Care_Coordination_Center@bjc.org

Phone

800-600-3606

First Name & Middle Initial & Last Name & Degree

Saiama Waqar, MD

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nathan Pennell, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

AL8326 in SCLC Treatment

We'll reach out to this number within 24 hrs