Evaluation of the safety and efficacy of the drug AL8326 in the post-first treatment of small cell lung cancer.

Phase 2

Not yet recruiting

• Conditions: Small Cell Lung Cancer (SCLC) patients who need ≥2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage.
• Interventions: Drug: AL8326 low dose group; Drug: AL8326 middle dose group; Drug: AL8326 high dose group

• Registration Number: 2023-509067-24-01
• Lead Sponsor: Advenchen Pharmaceuticals LLC

Brief Summary

To determine the optimal biological dose (OBD) based on efficacy and safety of each dosing group.

ORR for all dosing groups and OBD group plus expansion cohort for = or >2nd line treatment of AL8326 for SCLC patients.

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.

A phase 2 expansion cohort will be continued if a positive clinical result would have been observed after OBD determination for 40-60 patients. Upon FDA's approval the Phase 2 expansion cohort clinical study will be further expanded to evaluate the safety and efficacy of AL8326 in patients individually with SCLC who need = or \>2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage.

Study Timeline

• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 30

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. 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.

Exclusion Criteria

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
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OBD finding cohort at low dose	AL8326 low dose group	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.
OBD finding cohort at middle dose	AL8326 middle dose group	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.
OBD finding cohort at high dose	AL8326 high dose group	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.

Primary Outcome Measures

Name	Time	Method
OBD and ORR for all dosing groups and OBD group plus expansion cohort		OBD and ORR for all dosing groups and OBD group plus expansion cohort

Secondary Outcome Measures

Name	Time	Method
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		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

Trial Locations

Locations (9)

Complexo Hospitalario Universitario A Coruna; 🇪🇸 A Coruna, Spain

Hospital Universitario Ramon Y Cajal; 🇪🇸 Madrid, Spain

Vall D'hebron Institut De Recerca; 🇪🇸 Barcelona, Spain

Hospital Universitario Y Politecnico La Fe; 🇪🇸 Valencia, Spain

Hospital Clinic De Barcelona; 🇪🇸 Barcelona, Spain

Fondazione Policlinico Universitario Campus Bio-Medico; 🇮🇹 Rome, Italy

European Institute Of Oncology S.r.l.; 🇮🇹 Milan, Italy

Istituto Oncologico Veneto; 🇮🇹 Padova, Italy

Fondazione IRCCS Istituto Nazionale Dei Tumori; 🇮🇹 Milan, Italy

Complexo Hospitalario Universitario A Coruna

🇪🇸A Coruna, Spain

Maria Rosario García Campelo

Site contact

+34981178000

ma.rosario.garcia.campelo@sergas.es