A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer
A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer
TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1).
The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and efficacy of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a).
This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease, defined as disease present at last tumor evaluation (within 3 months) prior to signing the ICF.
Participants will be enrolled into one of 2 cohorts:
Cohort A:
Cohort B:
Inclusion Criteria:
Exclusion Criteria:
For more information on eligibility criteria, please contact the Sponsor
clinicaltrials@protaratx.com16468440337
Homewood, Alabama 35209, United States
New York, New York 10016, United States
CABA, C1419, Argentina
CABA, C1419, Argentina
Porto Alegre, Rio Grande do Sul 90035-070, Brazil
Porto Alegre, Rio Grande do Sul 90430-001, Brazil
Toronto, Ontario M5G 1Z5, Canada
Montreal, Quebec H3H 2R9, Canada
Komaki-shi, Aichi-ken 485-0044, Japan
Funabashi-shi, Chiba 273-8588, Japan
Sakura-shi, Chiba 285-8741, Japan
Amagasaki-shi, Hyōgo 660-8550, Japan
Hitachi-shi, Ibaraki 317-0077, Japan
Fuji-shi, Shizuoka 417-8567, Japan
Kaohsiung City, Kanagawa 807561, Taiwan