Not Authorised Phase I and Phase II (Integrated)- Other Non-muscle invasive bladder cancer

Dose expansion, safety and efficacy study of intravesical instillation of TARA-002 in adults with high-grade non-muscle invasive bladder cancer

EU CTIS ID: 2023-505062-28-00

What this study is testing

Cohort A: To assess the preliminary anti-tumor activity of TARA-002 administered intravesically Cohort B: To assess the anti-tumor activity of TARA-002 administered intravesically using cystoscopy, bladder biopsy and urine cytology

Phase I and Phase II (Integrated)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Male or female subjects 18 years of age or older at the time of signing the informed consent
10. If sexually active with female partners, the sexually mature, nonsterile male agrees to use a medically acceptable method of contraception and abstains 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 informed consent. Acceptable methods of contraception include: a. The simultaneous use of stable hormonal contraception by the female partner in conjunction with a double-barrier method (e.g., condom with spermicide or diaphragm with spermicide), or; b. The female partner’s use of an intrauterine device in place for at least 12 weeks, in conjunction with a double barrier method, or; c. The female partner is surgically sterile for at least 6 weeks or is at least 12 months postmenopausal, or; d. Abstinence if this is the subject’s usual lifestyle and preferred contraception
11. Females of childbearing age 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.
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

You likely can't join if

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, subject is eligible for the study).
10. Concurrent or planned biologic therapy, hormonal therapy (other than oral contraception), chemotherapy, surgery (other than TURBT and/or biopsy), or other cancer therapy during study period. Note: concurrent or planned hormonal therapy refers to hormone treatment for cancer or immunosuppression, and does not refer to routine medications for chronic disease e.g. diabetes, hypothyroidism, osteoporosis
11. Concurrent malignancy diagnosed within 6 months prior to the time of signing the informed consent. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer, or low or very low risk prostate cancer. Note: history of prior malignancy is allowed so long as it is not concurrent or is stable for more than 6 months per the Investigator’s assessment
12. Receipt of any other anti-cancer therapy (including investigational agents) within 6 weeks prior to signing informed consent. Subjects who enrolled in any investigational treatment studies and received investigational therapies for high-grade NMIBC are excluded.
13. Inadequate organ and bone marrow function based on central laboratory defined as: a. Hemoglobin ≤ 8.0g/dL b. Absolute neutrophil count ≤ 1.5 x 109 / L c. Platelet count ≤ 80 x 109 / L d. Aspartate aminotransferase (AST)/aspartate transaminase (SGOT) and/or alanine aminotransferase (ALT)/alanine transaminase (SGPT) ≥ 2.5 x upper limit of normal (ULN) e. Total bilirubin >1.0 x ULN f. Creatinine Clearance < 30 mL/min (as calculated by central laboratory)
14. Current indwelling ureteral stent. If stent is anticipated to be removed prior to drug administration, this is allowed

See the full eligibility criteria

Who can join

1. Male or female subjects 18 years of age or older at the time of signing the informed consent
10. If sexually active with female partners, the sexually mature, nonsterile male agrees to use a medically acceptable method of contraception and abstains 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 informed consent. Acceptable methods of contraception include: a. The simultaneous use of stable hormonal contraception by the female partner in conjunction with a double-barrier method (e.g., condom with spermicide or diaphragm with spermicide), or; b. The female partner’s use of an intrauterine device in place for at least 12 weeks, in conjunction with a double barrier method, or; c. The female partner is surgically sterile for at least 6 weeks or is at least 12 months postmenopausal, or; d. Abstinence if this is the subject’s usual lifestyle and preferred contraception
11. Females of childbearing age 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.
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 a. CIS with active disease is defined as CIS (± Ta/T1) present on last tumor evaluation prior to signing ICF. The specimen containing CIS should be submitted for central review to determine eligibility. If re-staging TURBT was performed prior to signing informed consent, CIS with active disease may be determined from ANY specimen during this tumor evaluation period (i.e., staging or re-staging). b. Subjects with CIS + T1 without muscle in specimen should undergo re-staging TURBT to confirm eligibility (e.g., absence of muscle invasion). If re-staging was not completed prior to signing ICF, re-staging cystoscopy/cytology/TURBT can be performed in the same setting during screening. Local interpretation of restaging is acceptable to confirm eligibility. Study visits may be delayed by up to 28 days after TURBT/biopsy procedure only if required per the site’s standard of care. c. All papillary disease should be completely resected prior to dosing. d. If there is discrepancy for inclusion/exclusion between local pathology and central pathology, please contact the sponsor for guidance.
4. Cohort A only: Subjects with CIS (± Ta/T1) who are unable to obtain intravesical BCG or have not received intravesical BCG for 24 months prior to CIS diagnosis a. Inability to access BCG may include, but is not limited to, medical reasons or shortage-related reasons b. Inability to access BCG due to affordability-related reasons is not permitted
5. Cohort B only: BCG unresponsive CIS a. Persistent or recurrent CIS (± Ta/T1) within 12 months of completion of adequate BCG (at least 5 of 6 doses of an initial induction course plus either at least 2 of 3 doses of maintenance therapy or at least 2 of 6 doses of a second induction course)
6. Subjects enrolled in other investigational treatment studies (unrelated to high-grade NMIBC) 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). Subjects who were enrolled in other investigational treatment studies and received investigational therapies for highgrade NMIBC are excluded.
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, the female of childbearing potential agrees to use a medically acceptable method of contraception and abstains from donating eggs 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 pre-menopausal (menopause is defined as complete cessation of menstruation for at least 12 months). Acceptable methods of contraception include: a. The simultaneous use of stable hormonal contraception in conjunction with a double-barrier method (e.g., condom with spermicide or diaphragm with spermicide), or; b. The use of an intrauterine device in place for at least 12 weeks, in conjunction with a double barrier method, or; c. Abstinence if this is the subject’s usual lifestyle and preferred contraception

What rules you out

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, subject is eligible for the study).
10. Concurrent or planned biologic therapy, hormonal therapy (other than oral contraception), chemotherapy, surgery (other than TURBT and/or biopsy), or other cancer therapy during study period. Note: concurrent or planned hormonal therapy refers to hormone treatment for cancer or immunosuppression, and does not refer to routine medications for chronic disease e.g. diabetes, hypothyroidism, osteoporosis
11. Concurrent malignancy diagnosed within 6 months prior to the time of signing the informed consent. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer, or low or very low risk prostate cancer. Note: history of prior malignancy is allowed so long as it is not concurrent or is stable for more than 6 months per the Investigator’s assessment
12. Receipt of any other anti-cancer therapy (including investigational agents) within 6 weeks prior to signing informed consent. Subjects who enrolled in any investigational treatment studies and received investigational therapies for high-grade NMIBC are excluded.
13. Inadequate organ and bone marrow function based on central laboratory defined as: a. Hemoglobin ≤ 8.0g/dL b. Absolute neutrophil count ≤ 1.5 x 109 / L c. Platelet count ≤ 80 x 109 / L d. Aspartate aminotransferase (AST)/aspartate transaminase (SGOT) and/or alanine aminotransferase (ALT)/alanine transaminase (SGPT) ≥ 2.5 x upper limit of normal (ULN) e. Total bilirubin >1.0 x ULN f. Creatinine Clearance < 30 mL/min (as calculated by central laboratory)
14. Current indwelling ureteral stent. If stent is anticipated to be removed prior to drug administration, this is allowed
15. A woman who is nursing, pregnant, or intending to become pregnant during the study period
16. Known human immunodeficiency (HIV) infection or other immunodeficiency disorders, either primary or acquired. Exceptions include subjects requiring use of inhaled or intranasal corticosteroids or local steroid injections
17. In the opinion of the treating Investigator, the subject has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate
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 a. Prior history of prostatic and upper tract disease is acceptable as long as there is no disease in these areas at the time of dosing
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 judgement 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. This determination is based on Investigator’s assessment.
6. Life expectancy of less than 5 years
7. ECOG performance status 3 or 4
8. Has received prior radiotherapy to the pelvis
9. Has significant urinary incontinence or otherwise unable to hold intravesical immunotherapy in the bladder for 2 hours, per the Investigator’s assessment

The study team makes the final eligibility decision.

Where it's taking place

United States
Ukraine

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; Ukraine. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.