Phase 2 Safety and Efficacy Evaluation of AL8326 in ≥2nd Line SCLC

A

Advenchen

Status and phase

Enrolling
Phase 2

Conditions

Small Cell Lung Cancer

Treatments

Drug: AL8326 middle dose group
Drug: AL8326 high dose group
Drug: AL8326 low dose group

Study type

Interventional

Funder types

Industry

Identifiers

NCT05363280
AL8326-US-001

Details and patient eligibility

About

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 who need ≥2nd line treatment .

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Major Inclusion Criteria:

  • Male or female, 18 years of age or older
  • ECOG performance status of 0 or 1
  • Histologically or cytologically confirmed SCLC
  • Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1
  • Have a life expectancy of at least 3 months

Major 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.

More information available upon request

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 3 patient groups

OBD finding cohort at low dose
Experimental group
Description:
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.
Treatment:
Drug: AL8326 low dose group
OBD finding cohort at middle dose
Experimental group
Description:
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.
Treatment:
Drug: AL8326 middle dose group
OBD finding cohort at high dose
Experimental group
Description:
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.
Treatment:
Drug: AL8326 high dose group

Trial contacts and locations

4

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Central trial contact

Judy Chen; Shiying Sprinzl

Data sourced from clinicaltrials.gov

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