A Phase Ib/II, Dose Expansion, Open-label Study to Evaluate Safety and Efficacy, of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
Study Identifier:
TARA-002-101-PH2
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study Summary
TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy 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 efficacy 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 (within 3 months) prior to signing the 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 who are BCG unresponsive.
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 .
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bladder
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: 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
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
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 (plus or minus 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 CIS (plus or minus Ta/T1) who are BCG unresponsive.
- 1 After the nature of the study was explained, participants voluntarily signed written informed consent forms.
- 2 The participant had active high-grade NMIBC disease, confirmed by central histological examination. Active disease is defined as disease present at the most recent tumor assessment (≤3 months) prior to signing the ICF.
- 3 Phase Ib: Participants who have not received treatment, have received at least one dose of BCG, or have received at least one dose of chemotherapy.
- 4 Phase II: Cohort A [End of Enrollment]: Participants who have not received BCG treatment are defined as: HG CIS (±Ta/T1) NMIBC participants who have never received BCG treatment before; or HG CIS (±Ta/T1) NMIBC participants who have received BCG treatment before but have not received intravesical BCG instillation within at least 24 months prior to their most recent CIS diagnosis.
- 5 Phase II: Cohort B: HG CIS (±Ta/T1) NMIBC participants unresponsive to BCG, defined as having persistent or recurrent CIS with or without Ta/T1 disease within 12 months of adequate BCG therapy; high-grade Ta/T1 disease recurring within 6 months of adequate BCG therapy; or high-grade T1 bladder disease at the first assessment after BCG induction. Participants must receive at least 5/6 of the dose during induction.
- 6 If enrolled in another experimental-treatment study, last treatment must have been at least 6 weeks before informed consent.
- 7 Researchers believe participants can and will comply with program requirements.
- 8 ECOG fitness scores 0, 1, or 2.
- 9 Sexually active fertile women with male partners agreed to medically acceptable contraception during the study and for at least 4 weeks after the last investigational dose.
- 10 Sexually active sexually mature unsterile men with female partners agreed to medically acceptable contraception during the study and for at least 4 weeks after the last investigational dose and to avoid sperm donation.
- 11 Negative pregnancy test for a woman of childbearing age.
- 12 Attending physicians confirmed availability and accessibility of TARA-002.
Exclusion criteria
- - Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory. - Participants with centrally confirmed variant histology, including adenocarcinoma or squamous cell carcinoma. - 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.
- 1 Allergic to penicillin or known hypersensitivity to β-lactam antibiotics.
- 2 Any histological variant confirmed by the center.
- 3 Researchers assessed that there was a concurrent prostate or epithelial lesion.
- 4 If the participant currently has or has a history of lymph node and metastatic disease.
- 5 If the participant has a history of ≥T2 bladder cancer.
- 6 Life expectancy is less than 5 years.
- 7 Participants had a known or documented history of severe urinary incontinence or a suspected inability to undergo intravesical immunotherapy for 1.5 hours (±30 minutes).
- 8 During the study period, patients were undergoing or planned to undergo immunosuppressive therapy, hormone therapy (excluding oral contraceptives and treatments permitted by the study protocol), systemic chemotherapy, surgery (excluding TURBT and/or biopsy), or other cancer treatments.
- 9 The individual was diagnosed with a concurrent malignant tumor within 6 months prior to signing the informed consent form.
- 10 The patient had received any other anticancer treatment for urothelial carcinoma (including any investigational drug) within 6 weeks prior to the first administration of the investigational drug.
- 11 Organ and bone marrow dysfunction (based on central laboratory tests), as defined in the study protocol.
- 12 Participants with SBP > 180 mmHg and/or symptomatic heart failure.
- 13 Participants in current ureteral stent placement.
- 14 Women who are breastfeeding, pregnant, or planning to become pregnant during the study.
- 15 Human immunodeficiency virus (HIV) infection or other primary or acquired immunodeficiency diseases are known to exist.
- 16 Any pre-existing or current illness, treatment, or laboratory abnormality in a participant may confound trial results, affect participation during the study, or be in the participant's best interest.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Abhishek Srivastava
Status
Recruiting
Condition(s) Treated at Site
Bladder