Recruiting
Phase 2

AL8326

Sponsor:

Advenchen Pharmaceuticals, LLC.

Code:

NCT05363280

Conditions

Small Cell Lung Cancer

Renal Cell Carcinoma (RCC)

Non-Small Cell Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AL8326 40 mg

AL8326 60 mg

AL8326 80 mg--stopped

Study Details

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

Study ID

NCT05363280

Start date

Nov 1, 2022

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

experimental: Non-Small Cell Lung(NSCLC)

≥2nd line NSCLC patient in 40 mg dose

experimental: Renal Cell Carcinoma( RCC )

≥2nd line RCC patient in 60 mg dose

Interventions

AL8326 40 mg

Taken AL3826 at 40mg QD orally

AL8326 60 mg

Taken AL3826 at 60mg QD orally

AL8326 80 mg--stopped

Taken AL3826 at 80 mg QD orally

Primary outcome measure

  • Optimal biological dose ( OBD ) [ Time Frame: 12 months ]
  • Objective Response Rates (ORR) [ Time Frame: 12 month ]
  • ORR evaluation for NSCLC and RCC [ Time Frame: 24 month ]

Central Contacts and Locations

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Clinical Research Manager

205-934-6454annaburton@uabmc.edu

Principal Investigator:

Aakash Desai, MD

Siteman Cancer Center, Washington University

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Principal Investigator:

Saiama Waqar, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Cancer Answer Line (Taussig)

216-444-7923

Principal Investigator:

Lukas Delasos, MD

More Information

Sponsor

Advenchen Pharmaceuticals, LLC.

Last update posted

May 8, 2026

Last verified

Apr, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Advenchen Pharmaceuticals, LLC. on 2026-05-08.