IMMU-132 in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03725761|
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : November 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: IMMU-132||Phase 2|
This study will investigate the safety and efficacy of IMMU-132 in patients with metastatic castration-resistant prostate cancer progressing on abiraterone or enzalutamide. Patients who have progressed while on therapy with combination enzalutamide/abiraterone or ARN-509/abiraterone as part of ongoing clinical trials are allowed and may be enrolled in the study. To better understand the heterogeneity of response and in particular to identify patients likely to benefit, an extensive correlative biomarker program will be included to collect and analyze tumor tissue biopsies, circulating tumor cells (CTCs), and circulating tumor DNA (ctDNA).
A validated predictive biomarker would benefit the individual patient by enabling him to be treated with a safe effective oral drug and avoid one from which he is unlikely to benefit. It is also essential for prostate cancer drug development because the increasing availability of more life-prolonging therapies is making it more difficult to prove a survival benefit for the next promising agent.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Safety and Efficacy of IMMU-132 (Sacituzumab Govitecan) in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed on Second Generation AR-Directed Therapy|
|Actual Study Start Date :||October 24, 2018|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||June 1, 2021|
Experimental: IMMU-132 Treatment
Subjects enrolled in this study will receive IMMU-132 as treatment for Castrate-Resistant Prostate Cancer. Dose will be calculated per protocol in milligrams based on the subject's body weight at the beginning of each cycle or more frequently if weight changes >10%. Subjects will be treated on days 1 and 8 in a 21-day cycle, minimum 3 cycles.
IMMU-132 is a novel Antibody Drug Conjugate (ADC) based on a humanized anti-Trop-2 antibody (hRS7) conjugated to SN-38 payload.
Other Name: Sacituzumab Govitecan
- PSA response rate [ Time Frame: up to 9 weeks ]Subjects who achieve ≥50% PSA decline at or before 9 weeks of therapy with IMMU-132 are considered to have responded. PSA responses will be analyzed by descriptive statistics and summarized in tabular format (frequency tables). The overall PSA response rate will be reported along with the corresponding 95% confidence interval which will be constructed using the Wilson score method.
- 6-Month Median Progression Free Survival [ Time Frame: 6 months ]Proportion of subjects remaining alive and progression free (using PCWG2 criteria) 6 months from time of starting treatment as estimated by the Kaplan-Meier method.
- Median Progression Free Survival Rate [ Time Frame: Up to 2 years from start of treatment ]The probability distribution of Progression Free Survival (PFS) will be estimated using the Kaplan-Meier method. The median will be estimated from this distribution. Subjects who have not died or progressed (using PCWG2 criteria) will be censored at the date of last assessment.
- Radiologic Response Rate [ Time Frame: up to 2 years from start of treatment ]Number of subjects with reduction in tumor size compared to baseline.
- Median Overall Survival [ Time Frame: Up to 2 years from start of treatment ]Overall Survival (OS) is the duration from start of treatment until death from any cause. The probability distribution of OS will be estimated using the Kaplan-Meier method. The median will be estimated from this distribution. Subjects who have not died will be censored at the date of last contact.
- Toxicity rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, etc.) [ Time Frame: Up to 9 weeks from start of treatment ]Toxicities will be summarized by type and severity in tabular format. Toxicity rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, etc.) will be calculated and reported along the corresponding 95% confidence intervals. The 95% confidence intervals will be constructed using the Wilson score method.
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): NCT03725761
|Contact: Cancer Connectemail@example.com|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Rebecca Green 646-888-1313 firstname.lastname@example.org|
|Principal Investigator: Susan Slovin, MD|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10065|
|Contact: Jyoti Sreekumar 646-962-9340 email@example.com|
|Principal Investigator: Himisha Beltran, MD|
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Mary Jane Staab 608-263-7107 firstname.lastname@example.org|
|Principal Investigator: Christos Kyriakopoulos|
|Principal Investigator:||Joshua Lang, MD||University of Wisconsin, Madison|