sEphB4-HSA in Treating Participants With BCG-Unresponsive or Refractory Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT03552796|
Recruitment Status : Not yet recruiting
First Posted : June 12, 2018
Last Update Posted : October 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Bladder Carcinoma Bladder Cancer Stage 0 Bladder Cancer Stage I||Other: Pharmacokinetic Study Biological: Recombinant EphB4-HSA Fusion Protein||Phase 1|
I. To establish the maximum tolerated dose (MTD) and recommended phase II dosing (RP2D) of intravesical sEphB4-HSA administration.
II. To describe the dose limiting toxicities and adverse event profile of intravesical sEphB4-HSA administration in patients with bladder carcinoma in situ (CIS) and/or high grade T1/Ta bladder cancer (BCa).
III. To describe the pharmacokinetics of intravesical sEphB4-HSA administration.
IV. To explore the anti-tumor activity of intravesical sEphB4-HSA administration as manifested by responses to treatment.
OUTLINE: This is a dose-escalation study.
Participants receive sEphB4-HSA intravesically over 2 hours on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 30 days, and again at 3 and 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A First-in-Human Phase I Study of Intravesical sEphB4-HSA in Patients With "BCG-Unresponsive" Bladder Carcinoma In Situ (CIS), Completely Resected High Grade Ta/T1, to Establish the Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)|
|Estimated Study Start Date :||December 9, 2019|
|Estimated Primary Completion Date :||December 9, 2021|
|Estimated Study Completion Date :||December 9, 2022|
Cohorts of at least 3 participants each will be treated with escalating doses of sEphB4-HAS at 25mg, 50 mg, 75mg, 100 mg, and 125 mg administered intravesically over 2 hours once a week for 6 consecutive weeks to determine the maximum tolerated dose (MTD) and recommended phase II dosing (RP2D). Cycle repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Other: Pharmacokinetic Study
Biological: Recombinant EphB4-HSA Fusion Protein
Other Name: sEphB4-HSA
- Incidence of adverse events [ Time Frame: Up to 6 months ]Adverse events will be evaluated in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) [ Time Frame: Up to 6 months ]The MTD is defined as the highest dose tested in which none or only one patient experienced DLT attributable to the study drug, when 6 patients were treated at that dose and are evaluable for toxicity. The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced DLT attributable to the study drug. The MTD will be the RP2D.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552796
|Contact: Cheryl Kefauver, RN||323-865-0459||Cheryl.Kefauver@med.usc.edu|
|United States, California|
|USC / Norris Comprehensive Cancer Center||Not yet recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Cheryl Kefauver, RN 323-865-0459 Cheryl.Kefauver@med.usc.edu|
|Principal Investigator: Monish Aron, MD|
|Principal Investigator:||Monish Aron, MD||University of Southern California|