A Phase 2 Evaluation of the Safety and Efficacy of AL8326 in ≥2nd Line Small Cell Lung Cancer (SCLC) Treatment

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509067-24-01

Acronym

AL8326-US-001

Enrollment

Registered

2025-02-10

Start date

2025-06-17

Completion date

Unknown

Last updated

2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer (SCLC) patients who need ≥2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage.

Brief summary

OBD and ORR for all dosing groups and OBD group plus expansion cohort

Detailed description

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

Interventions

DRUGAL8326

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
OBD and ORR for all dosing groups and OBD group plus expansion cohort	—

Secondary

Measure	Time frame
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	—

Countries

Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026