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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

ConditionsSmall Cell Lung CancerRenal Cell Carcinoma (RCC)Non-Small Cell Lung
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdvenchen Pharmaceuticals, LLC.

About this trial

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 .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • AL8326 40 mg

    Drug

    Taken AL3826 at 40mg QD orally

  • AL8326 60 mg

    Drug

    Taken AL3826 at 60mg QD orally

  • AL8326 80 mg--stopped

    Drug

    Taken AL3826 at 80 mg QD orally

Treatment groups

80 Participants
are divided into 5 treatment groups
Group A: OBD finding cohort at low dose--completedExperimental treatment 1 intervention
Group B: OBD finding cohort at middle dose--completedExperimental treatment 1 intervention
Group C: OBD finding cohort at high dose--completedExperimental treatment 1 intervention
Group D: Non-Small Cell Lung(NSCLC)Experimental treatment 1 intervention
Group E: Renal Cell Carcinoma( RCC )Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Optimal biological dose ( OBD )

Determine the Optimal biological dose ( OBD ) via evaluation of dose limiting toxicity (DLT) events to decide the dosing using in expanded cohort

Time frame
12 months
2

Objective Response Rates (ORR)

Evaluate the efficacy among 3 different dosing groups

Time frame
12 month
3

ORR evaluation for NSCLC and RCC

ORR evaluation for NSCLC and RCC

Time frame
24 month

Secondary outcomes

1

Duration of response ( DOR)

DOR for SCLC OBD group plus expansion cohort, NSCLC and RCC cohortgroup;

Time frame
36 month
2

Progression-Free Survival (PFS)

PFS for SCLC OBD group plus expansion cohort, NSCLC and RCC cohortgroup

Time frame
36 month
3

Pharmacokinetic endpoints

Pharmacokinetic endpoints Maximum Plasma Concentration ( Cmax)

Time frame
24 month
4

Pharmacokinetic endpoint Area Under the Curve (AUC)

Time frame
24 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Advenchen Pharmaceuticals, LLC.

Lead sponsor

Source ClinicalTrials.gov
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