Non-muscle Invasive Bladder Cancer
Conditions
Keywords
Non-muscle invasive bladder cancer, bladder cancer, high grade Ta, carcinoma in situ, high-grade NMIBC
Brief summary
This study is an open-label dose escalation study (Phase 1a) to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of bladder tumor (TURBT) and/or biopsy using TARA-002 in adults unable to obtain intravesical Bacillus Calmette-Guérin (BCG), adults who have received at least one dose of intravesical BCG or adults who have received at least one dose of intravesical chemotherapy. Dosing will start in subjects with HGTa or CIS (including CIS with concomitant Ta), and all subjects will receive 6 weeks of treatment at a fixed volume with varying dose levels.
Interventions
BIOLOGICALTARA-002
Phase 1a, Dose Escalation: First, up to 3 dose levels of TARA-002 (10 KE → 20 KE → 40 KE) will be tested sequentially with 6 weekly intravesical doses starting with the lowest dose using a 3+3 design in a dose escalation manner until the RP2D has been established. If the MTD is not reached, additional cohorts of dose levels higher than 40 KE may be explored.
Sponsors
Protara Therapeutics
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
First, up to 3 dose levels of TARA-002 (10 KE → 20 KE → 40 KE) will be tested sequentially with 6 weekly intravesical doses starting with the lowest dose using a 3+3 design in a dose escalation manner until the RP2D has been established. If the MTD is not reached, additional cohorts of dose levels higher than 40 KE may be explored.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects 18 years of age or older at the time of signing the informed consent * 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 assessment * Nodal involvement or metastatic disease that existed at any time (past or present disease) * Bladder cancer stage ≥ T1 within the last 36 months according to central histology review * Bladder cancer stage CIS with concomitant T1 For more information on eligibility criteria, please contact the sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a, Dose Escalation Phase: Incidence of DLT AEs in subjects with HGTa or CIS NMIBC | Day 1 to Day 43 | DLT = dose limiting toxicities; HGTa = high grade Ta; CIS = carcinoma in situ, includes CIS with concomitant Ta |
| Phase 1a, Dose Escalation Phase: MTD and RP2D of TARA-002 in subjects with HGTa or CIS NMIBC | Day 1 to Day 43 | MTD = maximum tolerated dose; RP2D = recommended Phase 2 dose |
Countries
Moldova, Romania, Ukraine, United States
Outcome results
None listed