RecruitingPhase 2

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

United States80 participantsStarted 2022-11-01

Plain-language summary

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 .

Who can participate

Age range18 Years

SexALL

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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

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.

What they're measuring

Optimal biological dose ( OBD )

Timeframe: 12 months

Objective Response Rates (ORR)

Timeframe: 12 month

ORR evaluation for NSCLC and RCC

Timeframe: 24 month

Trial details

NCT IDNCT05363280

SponsorAdvenchen Pharmaceuticals, LLC.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Shiying Sprinzl

805-530-1550 shiyings@advenchen.com

View on ClinicalTrials.gov More Small Cell Lung Cancer trials