Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

BCG Vaccine

* APL-1202 will be administered orally at daily 750 mg (250 mg, TID) for 5-7 days prior to the first intravesical BCG treatment and continue for additional 11 weeks (a total 12 weeks of dosing with APL-1202).
* Standard intravesical BCG induction course (once weekly for 6 weeks) 50 mg TICE BCG in 50 mL sterile saline (or a full dose standard vial of BCG) will be initiated on Week 2.

To assess the safety and pharmacokinetics of APL-1202 alone and in combination with Bacillus Calmette Guerin

APL-1202

Harish Dave, MD

A Phase Ib, open label, non randomized study to measure the safety and PK characteristics of APL-1202 at steady-state in adult male and female BCG resistant NMIBC patients when it is administered alone and concurrently with BCG.

Six eligible participants will be administered with APL-1202 one week prior to the first BCG instillation, during the six-week course of BCG instillation, and additional five weeks, for a total of 12 weeks of dosing. Safety assessment will be performed during the entire 13 week study duration. Plasma and urine samples will be collected from each participant at prior to first and fifth BCG instillations for PK analysis.

Study of APL-1202 in Non-Muscle Invasive Bladder Cancer Patients Who Are Resistant to One Induction Course of BCG Treatment

A Phase Ib Study of APL-1202 in NMIBC Patients Who Are Resistant to One Induction Course of BCG Treatment

Incidence and Severity of Treatment-Related Adverse Events as Assessed by CTCAE v.5.0 or newer

PK measurement expressed as area under curve for APL-1202

PK measurement expressed as maximum plasma concentration for APL-1202

PK measurement expressed as half-life for APL-1202

PK measurement expressed as cumulative amount in urinary excretion for APL-1202

PK measurement expressed as cumulative fraction of dose in urinary excretion for APL-1202

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of APL-1202 in Non-Muscle Invasive Bladder Cancer Patients Who Are Resistant to One Induction Course of BCG Treatment	NCT03672240	Non-Muscle Inva...	APL-1202	18 Years - 99 Years	AsierisPharma
Study of APL-1202 in Non-Muscle Invasive Bladder Cancer Patients Who Are Resistant to One Induction Course of BCG Treatment	NCT03672240	Non-Muscle Inva...	APL-1202	18 Years - 99 Years	AsierisPharma
Study of APL-1202 in Non-Muscle Invasive Bladder Cancer Patients Who Are Resistant to One Induction Course of BCG Treatment	NCT03672240	Non-Muscle Inva...	APL-1202	18 Years - 99 Years	AsierisPharma

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