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

Advenchen

Status and phase

Enrolling

Phase 2

Conditions

Renal Cell Carcinoma (RCC)

Small Cell Lung Cancer

Non-Small Cell Lung

Treatments

Drug: AL8326 40 mg

Drug: AL8326 60 mg

Drug: AL8326 80 mg--stopped

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 , Non-Small Cell Lung (NSCLC) and Renal Cell Carcinoma 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.

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.

Enrollment

80 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 /NSCLC/RCC
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)

80 participants in 5 patient groups

OBD finding cohort at low dose--completed

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 40 mg

OBD finding cohort at middle dose--completed

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 60 mg

OBD finding cohort at high dose--completed

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 80 mg--stopped

Non-Small Cell Lung(NSCLC)

Experimental group

Description:

≥2nd line NSCLC patient in 40 mg dose

Treatment:

Drug: AL8326 40 mg

Renal Cell Carcinoma( RCC )

Experimental group

Description:

≥2nd line RCC patient in 60 mg dose