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

May 5, 2026 updated by: Advenchen Pharmaceuticals, LLC.

A Phase 2 Evaluation of the Safety and Efficacy of Veonetinib (AL8326) in ≥2nd Line Small Cell Lung Cancer (SCLC), Non Small Cell Lung Cancer (NSCLC) and Renal Cell Carcinoma (RCC) 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 , Non-Small Cell Lung (NSCLC) and Renal Cell Carcinoma patients who need ≥2nd line treatment .

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

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. 40mg and 60mg cohort group can be expanded to an additional 6-12 patients in each cohort with only sparse PK sampling requirement if OBD is not able to be determined in early 12 patients of each cohort. Non-Small Cell Lung (NSCLC) and Renal Cell Carcinoma (RCC) are added to this protocol as additional expansion cohorts.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Pedro Filipe Simoees Da Rocha, MD
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
          • Cliical study coordinator
          • Phone Number: (+34) 91 3368831
        • Principal Investigator:
          • María Eugenia Olmedo García, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Principal Investigator:
          • Aakash Desai, MD
        • Contact:
    • Florida
      • Weston, Florida, United States, 33331
        • Withdrawn
        • Cleveland Clinic Florida
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Completed
        • Northwestern University
    • Missouri
      • St Louis, Missouri, United States, 63130
        • Recruiting
        • Siteman Cancer Center, Washington University
        • Contact:
          • Phone Number: 800-600-3606
        • Contact:
        • Principal Investigator:
          • Saiama Waqar, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Cancer Answer Line (Taussig)
          • Phone Number: 216-444-7923
        • Principal Investigator:
          • Lukas Delasos, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 /NSCLC/RCC
  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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OBD finding cohort at low dose--completed
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
Taken AL3826 at 40mg QD orally
Experimental: OBD finding cohort at middle dose--completed
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
Taken AL3826 at 60mg QD orally
Experimental: OBD finding cohort at high dose--completed
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
Taken AL3826 at 80 mg QD orally
Experimental: Non-Small Cell Lung(NSCLC)
≥2nd line NSCLC patient in 40 mg dose
Drug: AL8326 40 mg
Taken AL3826 at 40mg QD orally
Experimental: Renal Cell Carcinoma( RCC )
≥2nd line RCC patient in 60 mg dose
Drug: AL8326 60 mg
Taken AL3826 at 60mg QD orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimal biological dose ( OBD )
Time Frame: 12 months
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)
Time Frame: 12 month
Evaluate the efficacy among 3 different dosing groups
12 month
ORR evaluation for NSCLC and RCC
Time Frame: 24 month
ORR evaluation for NSCLC and RCC
24 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response ( DOR)
Time Frame: 36 month
DOR for SCLC OBD group plus expansion cohort, NSCLC and RCC cohortgroup;
36 month
Progression-Free Survival (PFS)
Time Frame: 36 month
PFS for SCLC OBD group plus expansion cohort, NSCLC and RCC cohortgroup
36 month
Pharmacokinetic endpoints
Time Frame: 24 month
Pharmacokinetic endpoints Maximum Plasma Concentration ( Cmax)
24 month
Pharmacokinetic endpoint Area Under the Curve (AUC)
Time Frame: 24 month
24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advenchen Pharmaceuticals, LLC.

Investigators

  • Principal Investigator: Saiama Waqar, MD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

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)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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