Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC (NCT04506567) | Clinical Trial Compass
Active ā Not RecruitingPhase 1/2
Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC
United States60 participantsStarted 2020-08-18
Plain-language summary
The purpose of the initial (phase I) portion of this study is to find a dose level and administration schedule of the study drug, 225Ac-J591, that can be given without severe side effects. The purpose of the second (phase II) portion of the study is to determine the proportion of those with PSMA-positive tumors with \>50% PSA decline following 225Ac-J591 treatment in two regimens.
Who can participate
Age range18 Years ā 99 Years
SexMALE
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Inclusion criteria
ā. Histologically or cytologically confirmed adenocarcinoma of prostate
ā. Documented progressive metastatic CRPC based on Prostate Cancer Working
ā. Have serum testosterone \< 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone orchiectomy
ā. Have previously been treated with at least one of the following in any disease state:
ā. Have previously received taxane chemotherapy (in any disease state), been determined to be ineligible for taxane chemotherapy by their physician, or refused taxane chemotherapy.
ā. Age \> 18 years
ā. Patients must have normal organ and marrow function as defined below:
ā. ECOG performance status of 0-2
Exclusion criteria
ā. Implantation of investigational medical device ā¤4 weeks of Treatment Visit 1 (Day 1) or current enrollment in oncologic investigational drug or device study
ā. Use of investigational drugs ā¤4 weeks or \<5 half-lives of Cycle 1, Day 1 or current enrollment in investigational oncology drug or device study
Number of participants with dose limiting toxicity (DLT)
Timeframe: Collected from Day 1 through 6 months
2
Cumulative maximum tolerated dose (MTD)
Timeframe: Collected from Day 1 through 6 months
3
Recommended phase II dose (RP2D) of 225Ac-J591 in fractionated dose and multiple dose regimens both pre- and post-treatment with 177Lu-PSMA-RL
Timeframe: Collected from Day 1 through 6 months
4
Proportion of participants with PSMA-positive tumors with >50% PSA decline following 225Ac-J591 in two regimens both pre- and post- treatment with 177Lu-PSMA-RL
Timeframe: Collected from Day 1 through 6 months
Trial details
NCT IDNCT04506567
SponsorWeill Medical College of Cornell University
. For patients enrolled in the post-177Lu-PSMA-RL cohorts: prior radium-223
ā. Untreated hydronephrosis
ā. Known active brain metastases or leptomeningeal disease
ā. History of deep vein thrombosis and/or pulmonary embolus within 1 month of C1D1
ā. Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study