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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Advenchen Pharmaceuticals, LLC.
Study ID
NCT05363280
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AL8326 40 mg — DRUG
    Taken AL3826 at 40mg QD orally
  • AL8326 60 mg — DRUG
    Taken AL3826 at 60mg QD orally
  • AL8326 80 mg--stopped — DRUG
    Taken AL3826 at 80 mg QD orally

Study Details

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 .

Key Dates

Start date
Nov 1, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Optimal biological dose ( OBD ) [ Time Frame: 12 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Clinical Research Manager
[email protected]
205-934-6454
Aakash Desai, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FloridaWestonFlorida33331-
Northwestern UniversityChicagoIllinois60611-
Siteman Cancer Center, Washington UniversitySt LouisMissouri63130
[email protected]
314-747-7222
800-600-3606
Saiama Waqar, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Cancer Answer Line (Taussig)
216-444-7923
Lukas Delasos, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Alabama at Birmingham· Birmingham, ALCleveland Clinic Florida· Weston, FLNorthwestern University· Chicago, ILSiteman Cancer Center, Washington University· St Louis, MOCleveland Clinic· Cleveland, OH

Related Studies