225Ac-J591 Plus 177Lu-PSMA-I&T for mCRPC
|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: NCT04886986|
Recruitment Status : Not yet recruiting
First Posted : May 14, 2021
Last Update Posted : May 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: 225Ac-J591 Drug: 177Lu-PSMA-I&T Drug: 68Ga-PSMA-11||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II 225Ac-J591 Plus 177Lu-PSMA-I&T for Progressive Metastatic Castration Resistant Prostate Cancer|
|Estimated Study Start Date :||June 2021|
|Estimated Primary Completion Date :||December 24, 2024|
|Estimated Study Completion Date :||December 27, 2027|
Experimental: All Subjects
Patients enrolled in the study will receive the study drugs 225Ac-J591 and 177Lu-PSMA-I&T, along with 68Ga-PSMA-11.
30 - 40 KBq/kg (dose-escalation) every 8 weeks, for up to 2 cycles. Administered together with 177Lu-PSMA-I&T. Intravenous administration.
6.8 GBq (fixed dose) every 8 weeks, for up to 2 cycles. Administered together with 225Ac-J591. Intravenous administration.
Other Name: 177Lu-PNT2002
[185 ±74 MBq or 5 ±2 mCi] intravenous during screening, 12 weeks, 24 weeks. Imaging agent for PSMA PET/CT.
Other Name: 68Ga-PSMA-HBED-CC
- Proportion of subjects with dose limiting toxicity (DLT) of 225Ac-J591 and 177Lu-PSMA-I&T during dose-escalation phase. [ Time Frame: Will be collected at the time of visit 1 through end of study or 100 months ]DLTs will be measured by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Cumulative maximum tolerated dose (MTD) and recommended phase II dose 225Ac-J591 and 177Lu-PSMA I&T [ Time Frame: Will be collected at the time of visit 1 through end of study or 100 months ]The dose that produces an "acceptable" level of toxicity or that, if exceeded, would put subjects at "unacceptable" risk for toxicity. Definition of the MTD usually relies on the sample, as MTD is defined as the dose level at which no more than one patient out of six experienced dose-limiting toxicity (DLT).
- Proportion of PSMA+ subjects (by imaging criteria) with PSA decline following treatment with the combination of 225Ac-J591 and 177Lu-PSMA I&T. [ Time Frame: Will be collected at the time of visit 1 through end of study or 100 months ]Proportion of patients acheiving 50% or greater PSA decline (relative to baseline/pre-treatment PSA). Response may occur at any time following treatment initiation and prior to going off study or initiation of new therapy.
- Change in biochemical progression-free survival [ Time Frame: Will be collected at the time of visit 1 through end of study or 100 months ]PSA progression will be defined as a rise of > 25% above either the pretreatment level or the nadir PSA level (whichever is lowest). PSA must increase by > 2 ng/ml to be considered progression.
- Change in circulating tumor cells (CTC) count [ Time Frame: Samples will be collected at screening, week 12, week 24. ]CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing
- Number of subjects with radiographic response rate [ Time Frame: Patients will undergo imaging at screening, week 12, and week 24. ]Response evaluation criteria in solid tumors RECIST (Version 1.1) criteria with prostate cancer working group 3 (PCWG3) modifications will be used.
- Safety of treatment and adverse event rate [ Time Frame: Will be collected at the time of visit 1 through end of study or 100 months. ]National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 is used to grade all adverse events
- Overall survival following treatment with 225Ac-J591 and 177Lu-PSMA-I&T [ Time Frame: Survival will be collected from Day 1 through study completion up to 100 months ]Overall survival will be captured through in-clinic or telephone contact with subjects
- Change in disease assessment with 68Ga-PSMA-11 PET/CT prior to and following investigational treatment [ Time Frame: Patients will undergo imaging at screening, week 12, and week 24. ]68Ga-PSMA-11 PET/CT will be utilized as part of the radiographic assessment.
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): NCT04886986
|Contact: GUONC Research Teamemail@example.com|
|United States, New York|
|Brooklyn Methodist Hospital - New York Presbyterian|
|Brooklyn, New York, United States, 11215|
|Contact: Lina Flores, RN 646-923-5883 firstname.lastname@example.org|
|Principal Investigator: David Nanus, MD|
|Weill Cornell Medicine New York Presbyterian|
|New York, New York, United States, 10065|
|Contact: GUONC Research Team email@example.com|
|Principal Investigator: Scott Tagawa, MD|
|Principal Investigator:||Scott Tagawa, MD MS||Weill Medical College of Cornell University|