RecruitingRecruiting
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 · Advenchen Laboratories, LLC
In plain English
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Official title
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
About this study
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.
Eligibility criteria
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 target: 80 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-11-01
Estimated completion: 2028-12
Last updated: 2026-05-08
Interventions
Drug: AL8326 40 mgDrug: AL8326 60 mgDrug: AL8326 80 mg--stopped
Primary outcomes
- • Optimal biological dose ( OBD ) (12 months)
- • Objective Response Rates (ORR) (12 month)
- • ORR evaluation for NSCLC and RCC (24 month)
Sponsor
Advenchen Pharmaceuticals, LLC. · industry
Contacts & investigators
ContactShiying Sprinzl · contact · shiyings@advenchen.com · 805-530-1550
ContactJudy Chen · contact · Judyc@advenchen.com · 805-530-1550
InvestigatorSaiama Waqar, MD · principal_investigator, Washington University School of Medicine
All locations (7)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Cleveland Clinic FloridaWithdrawn
Weston, Florida, United States
Northwestern UniversityCompleted
Chicago, Illinois, United States
Siteman Cancer Center, Washington UniversityRecruiting
St Louis, Missouri, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
Hospital Universitario Ramón Y CajalRecruiting
Madrid, Spain