PhIb/II IntravesInstillation of TARA-002 in Adults w/High-grade Non-muscle Invasive Bladder Cancer

Official Title

A Phase 2, Open-Label Study to Evaluate Safety and Anti-Tumor Activity, of Intravesical Instillation of TARA-002 in Adults with High-Grade Non-Muscle Invasive Bladder Cancer

Details

The purpose of this Phase 2 study is to assess the anti-tumor activity and safety of TARA-002, for the treatment of CIS (± Ta/T1) NMIBC with active disease (defined as disease present at last tumor evaluation prior to signing the informed consent form (ICF) at the recommended Phase 2 dose (RP2D) established during the Phase 1a study, TARA-002-101-Ph1a. The study will enroll subjects into 2 cohorts: Cohort A includes subjects with CIS (± Ta/T1) who are BCG naïve, or subjects with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis; Cohort B includes subjects with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (minimum 5/6 doses induction and 2/3 doses maintenance or 2/6 doses reinduction).

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5.1. Inclusion Criteria

To participate in this study, all subjects must meet all inclusion criteria described.

1. Male or female subjects 18 years of age or older at the time of signing the ICF
2. Subjects who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
3. Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease
4. Cohort A only: Subjects with CIS (± Ta/T1) who are BCG naïve or subjects with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis.
5. Cohort B only: BCG unresponsive CIS
6. Subjects enrolled in other investigational treatment studies should have received their last treatment at least 6 weeks prior to the time of signing the informed consent (i.e., 6-week washout period).
7. Subjects who the Investigator believes can and will comply with the requirements of the protocol.
8. Subjects with an ECOG performance status of 0, 1 or 2.
9. If sexually active with male partners, females of childbearing potential agree to use a medically acceptable method of contraception for the duration of the study and for at least 4 weeks after the last dose of investigational product. Females are considered of childbearing potential if they are post-menarche, have not been surgically sterile for at least 6 weeks (i.e., total hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation) and are premenopausal (menopause is defined as complete cessation of menstruation for at least 12 months).
10. If sexually active with female partners, sexually mature, nonsterile males agree to use a medically acceptable method of contraception and abstain from donating sperm for the duration of the study and for at least 4 weeks after the last dose of investigational product. Males are considered surgically sterile if they have undergone bilateral orchiectomy or vasectomy at least 12 weeks prior to signing the ICF.
11. Females of childbearing potential with a negative pregnancy test per local read
12. Subjects whose treating physician must confirm availability and access to TARA-002
13. Subjects who have not completed vaccination against COVID-19 should be negative for COVID-19 infection (according to local site requirements, e.g., rapid test, polymerase chain reaction [PCR] within the 42-day screening window PRIOR to receiving their first dose of TARA-002 at Treatment Day 1). Results can be read and interpreted locally.

5.2. Exclusion Criteria

To participate in this study, subjects must not meet ANY exclusion criteria described below:

1. Penicillin allergy (subjects with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory. If penicillin blood allergy test is negative, the subject is eligible for the study).
2. Central histologic review, predominant (defined as > 50%) adenocarcinoma, squamous cell carcinoma, or histological variants including plasmacytoid, sarcomatoid, or squamous components (Note: If predominant histology is urothelial, the subject is eligible for the study). Subjects with any micropapillary component will be excluded.
3. Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment
4. Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past). The determination of nodal and metastatic disease is determined by the Investigator after reviewing local imaging results. Note: A diagnosis of nodal and metastatic disease is not solely based on radiographic imaging, a clinical judgment and/or a histological investigation (if applicable) are factors the Investigator may use to assist in diagnosis of nodal or metastatic disease).
5. Any history of ≥T2 bladder cancer that existed at any point in time in the subject's history is excluded