Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade, Non-muscle Invasive Bladder Cancer


About this study

The primary objective of this study is to characterize the safety and toxicity profile of TARA-002 administered intravesically.




Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Male or female subjects 18 years of age or older at the time of signing the informed

- 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

- Subjects with a histologically confirmed, high-grade Ta or CIS (including CIS with
concomitant Ta) urothelial cell carcinoma of the bladder on central review

- Subjects who are treatment naïve, are unable to obtain intravesical BCG for the
treatment of NMIBC, have received at least one dose of intravesical BCG, or at least
one dose of intravesical chemotherapy

Exclusion Criteria:

- Penicillin allergy (subjects with a questionable history of allergy to penicillin or
no history of penicillin use will undergo penicillin blood allergy testing prior to
inclusion in the study)

- 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

- Nodal involvement or metastatic disease that existed at any time (past or present

- Bladder cancer stage ≥ T1 within the last 36 months according to central histology

- Bladder cancer stage CIS with concomitant T1

For more information on eligibility criteria, please contact the sponsor.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/13/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Paras Shah, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Timothy Lyon, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


Publications are currently not available

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