You have accessJournal of UrologyCME1 Apr 2023MP08-05 PHASE 1a/b STUDY OF INTRAVESICAL INSTILLATION OF TARA-002 IN ADULTS WITH HIGH-GRADE NON-MUSCLE INVASIVE BLADDER CANCER William Tabayoyong, Edward Messing, Sima Porten, Donald Lamm, Jathin Bandari, Jacqueline Zummo, Wei Sun, Khushboo Belani, Andrea DiFiglia, Eppie Brown, McKenna Metcalf, and Nuwan Nanayakkara William TabayoyongWilliam Tabayoyong More articles by this author , Edward MessingEdward Messing More articles by this author , Sima PortenSima Porten More articles by this author , Donald LammDonald Lamm More articles by this author , Jathin BandariJathin Bandari More articles by this author , Jacqueline ZummoJacqueline Zummo More articles by this author , Wei SunWei Sun More articles by this author , Khushboo BelaniKhushboo Belani More articles by this author , Andrea DiFigliaAndrea DiFiglia More articles by this author , Eppie BrownEppie Brown More articles by this author , McKenna MetcalfMcKenna Metcalf More articles by this author , and Nuwan NanayakkaraNuwan Nanayakkara More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003223.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Bladder cancer is the most common malignancy involving the urinary system, resulting in ∼18,000 US deaths/year; ∼70% of new urothelial bladder cancer cases are classified as non-muscle invasive bladder cancer (NMIBC). TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain treated with benzylpenicillin and is being developed for the treatment of high-grade (HG) NMIBC. TARA-002 is manufactured using the same master cell bank as OK-432 (Picibanil®). OK-432 is approved in Japan and Taiwan for the treatment of several oncology indications. We report on the design and progress of study ADVANCED-1 (NCT05085977; NCT05085990). METHODS: ADVANCED-1 is a P1a/b, dose finding, open-label study of intravesical TARA-002 in adults ≥ 18 yrs with HG NMIBC. The purpose of 1a dose escalation is to establish the maximum tolerated dose (MTD) and recommended P2 dose (RP2D) for the treatment of HGTa or CIS NMIBC (±Ta). The purpose of 1b dose expansion is to evaluate the anti-tumor activity and safety of induction ± re-induction of TARA-002 for the treatment of CIS NMIBC (±Ta/T1) with active disease at the established RP2D. 1a includes up to 18 subjects at 3 doses (10 KE, 20 KE, 40 KE) in a 3+3 design; 1b includes ∼102 subjects enrolled in 2 cohorts based on prior BCG experience: Cohort A includes subjects unable to obtain BCG and BCG-exposed subjects who have not received BCG in the last 24 months; Cohort B includes subjects with BCG unresponsive CIS. Those with a history of penicillin allergy or current evidence of any condition, therapy, or laboratory abnormality that might confound the results are excluded. The duration is 12 weeks per subject for 1a (includes induction), 6 months per subject for 1b-Cohort A (includes induction, reinduction [if applicable]), and 24 months per subject for 1b-Cohort B (includes induction; reinduction [if applicable]; maintenance until 18 months). RESULTS: In the 1a, at the time of writing, 3 subjects (2 female; 1 male) 66-80 yrs have completed treatment with TARA-002 at 10 KE with no dose limiting toxicities (DLT), and enrollment at 20 KE is ongoing. CONCLUSIONS: The 1a will establish the RP2D of TARA-002 and 1b will provide further evidence of anti-tumor activity and safety of TARA-002. Source of Funding: Protara Therapeutics, Inc. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e94 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information William Tabayoyong More articles by this author Edward Messing More articles by this author Sima Porten More articles by this author Donald Lamm More articles by this author Jathin Bandari More articles by this author Jacqueline Zummo More articles by this author Wei Sun More articles by this author Khushboo Belani More articles by this author Andrea DiFiglia More articles by this author Eppie Brown More articles by this author McKenna Metcalf More articles by this author Nuwan Nanayakkara More articles by this author Expand All Advertisement PDF downloadLoading ...
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