Phase 2 Study for the Patient, Who Has Diagnosed With Small Cell Lung Cancer (SCLC) or Non Small Cell Lung Cancer (NSCLC) or Renal Cell Carcinoma (RCC) and Finished the First Line Stand Treatment , Need More Treatment

NCT05363280 | Recruiting Phase 2 FDA Drug

• 1 other identifier: AL8326-US-001
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 7

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 , Non-Small Cell Lung (NSCLC) and Renal Cell Carcinoma patients who need ≥2nd line treatment .

Conditions

Small Cell Lung Cancer; Renal Cell Carcinoma (RCC); Non-Small Cell Lung

Keywords

Recurrent small cell lung caner; Advanced small cell lung cancer; Metastatic Small lung cancer; ≥2nd Line treatment; Non small cell lung cancer; Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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

• ORR evaluation for NSCLC and RCC

  ORR evaluation for NSCLC and RCC

  24 month

Secondary Outcomes (4)

• Duration of response ( DOR)

  36 month

• Progression-Free Survival (PFS)

  36 month

• Pharmacokinetic endpoints

  24 month

• Pharmacokinetic endpoint Area Under the Curve (AUC)

  24 month

Study Arms (5)

OBD finding cohort at low dose--completed

EXPERIMENTAL

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 40 mg

OBD finding cohort at middle dose--completed

EXPERIMENTAL

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 60 mg

OBD finding cohort at high dose--completed

EXPERIMENTAL

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 80 mg--stopped

Non-Small Cell Lung(NSCLC)

EXPERIMENTAL

≥2nd line NSCLC patient in 40 mg dose

Drug: AL8326 40 mg

Renal Cell Carcinoma( RCC )

EXPERIMENTAL

≥2nd line RCC patient in 60 mg dose

Drug: AL8326 60 mg

Interventions

AL8326 40 mg DRUG

Taken AL3826 at 40mg QD orally

Non-Small Cell Lung(NSCLC); OBD finding cohort at low dose--completed

AL8326 60 mg DRUG

Taken AL3826 at 60mg QD orally

OBD finding cohort at middle dose--completed; Renal Cell Carcinoma( RCC )

AL8326 80 mg--stopped DRUG

Taken AL3826 at 80 mg QD orally

OBD finding cohort at high dose--completed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years of age or older
• ECOG performance status of 0 or 1
• Histologically or cytologically confirmed SCLC /NSCLC/RCC
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Advenchen Pharmaceuticals, LLC.: lead

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Cleveland Clinic Florida

Weston, Florida, 33331, United States

WITHDRAWN

Northwestern University

Chicago, Illinois, 60611, United States

COMPLETED

Siteman Cancer Center, Washington University

St Louis, Missouri, 63130, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Spain

RECRUITING

Hospital Universitario Ramón Y Cajal

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Saiama Waqar, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiying Sprinzl

CONTACT

805-530-1550; shiyings@advenchen.com

Judy Chen

CONTACT

805-530-1550; Judyc@advenchen.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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. ----OBD patient enrollment of 40 mg (n=12) and 60 mg (N=12) have been completed, waiting data maturing, 80 mg (n=4) has been stopped due to high intolerability. A phase 2 expansion cohort will enroll SCLC--on hold NSCLC -≥2nd line treatment with up to n=15 patients in 40 mg RCC-≥2nd line treatment with up to n=15 patients in 60 mg

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 5, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-04

Locations

US (5); ES (2)