Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer (ADVANCED-2)

Protara Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Non-muscle Invasive Bladder Cancer

Treatments: Biological: TARA-002

Study type: Interventional

Funder types: Industry

Identifiers

NCT05951179

TARA-002-101-Ph2

Details and patient eligibility

About

TARA-002-101-Ph2 is an open-label study to investigate the safety and anti-tumor activity 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 anti-tumor activity 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 prior to signing ICF).

Participants will be enrolled into one of 2 cohorts:

Cohort A:

• Participants with CIS (± Ta/T1) who are BCG naive, or
• Participants 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:

• Participants 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)

Enrollment: 127 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participants 18 years of age or older at the time of signing informed consent
• Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
• Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease
• Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis (Cohort A). Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (Cohort B).

Exclusion criteria

• Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
• Predominant (defined as > 50%) adenocarcinoma, squamous cell carcinoma, or histological variants including plasmacytoid, sarcomatoid, or squamous components according to central review
• Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment
• Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)
• Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history

For more information on eligibility criteria, please contact the Sponsor

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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127 participants in 1 patient group

TARA-002

Experimental group

Description:

TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain treated with benzylpenicillin.

Treatment:

Biological: TARA-002