Evaluation of the safety and efficacy of the drug AL8326 in the post-first treatment of small cell lung cancer.
- Conditions
- Small Cell Lung Cancer (SCLC) patients who need =2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage., Small Cell Lung Cancer (SCLC) patients who need =2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage.Therapeutic area: Diseases [C] - Neoplasms [C04]MedDRA version: 21.1Level: PTClassification code: 10041067Term: Small cell lung cancer Class: 100000004864
- Registration Number
- CTIS2023-509067-24-00
- Lead Sponsor
- Advenchen Pharmaceuticals LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 130
1. Male or female, 18 years of age or older. 2. ECOG performance status of 0 or 1. 3. Histologically or cytologically confirmed SCLC. 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.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the optimal biological dose (OBD) based on efficacy and safety of each dosing group.<br>ORR for all dosing groups and OBD group plus expansion cohort for = or >2nd line treatment of AL8326 for SCLC patients.;Secondary Objective: To measure duration of response (DOR) for expansion cohort study. Progression Free Survival (PFS). To characterize PK profile of single dose and multiple doses, and PK/PD/Efficacy/Safety exposure relationship. Biomarker exploratory study., To measure duration of response (DOR) for expansion cohort study. Progression Free Survival (PFS). To characterize PK profile of single dose and multiple doses, and PK/PD/Efficacy/Safety exposure relationship. Biomarker exploratory study.;Primary end point(s): OBD and ORR for all dosing groups and OBD group plus expansion cohort
- Secondary Outcome Measures
Name Time Method Secondary end point(s):DOR for OBD group plus expansion cohort; PFS; Pharmacokinetic endpoints such as Cmax, AUC and other typic PK parameters; and PK/PD/Efficacy/Safety relationship. Possible biomarker identification