Phase I Trial of 225Ac-J591 in Patients With mCRPC

• ClinicalTrials.gov Identifier: NCT03276572
• Recruitment Status: Active, not recruiting
• First Posted: September 8, 2017
• Results First Posted: December 6, 2022
• Last Update Posted: December 6, 2022
• Sponsor: Weill Medical College of Cornell University
• Collaborators: Prostate Cancer Foundation; United States Department of Defense; National Institutes of Health (NIH); National Cancer Institute (NCI)
• Information provided by (Responsible Party): Weill Medical College of Cornell University

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer
• Intervention: Drug: 225Ac-J591
• Enrollment: 32

Participant Flow

Recruitment Details	Recruitment took place at at Weill Cornell Medicine New York Presbyterian and Tulane Medical Center.
Pre-assignment Details

Arm/Group Title	225Ac-J591 Cohort 1	225Ac-J591 Cohort 2	225Ac-J591 Cohort 3	225Ac-J591 Cohort 4	225Ac-J591 Cohort 5	225Ac-J591 Cohort 6	225Ac-J591 Cohort 7
Arm/Group Description	Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment	Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 7: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.
Period Title: Overall Study
Started	1	1	1	1	6	6	16
Completed	1	1	1	1	6	5	14
Not Completed	0	0	0	0	0	1	2
Reason Not Completed
In follow-up	0	0	0	0	0	1	1
Lost to Follow-up	0	0	0	0	0	0	1

Baseline Characteristics

Arm/Group Title		225Ac-J591 Cohort 1	225Ac-J591 Cohort 2	225Ac-J591 Cohort 3	225Ac-J591 Cohort 4	225Ac-J591 Cohort 5	225Ac-J591 Cohort 6	225Ac-J591 Cohort 7	Total
Arm/Group Description		Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment	Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 7 with Expansion: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment	Total of all reporting groups
Overall Number of Baseline Participants		1	1	1	1	6	6	16	32
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants	1 participants	1 participants	1 participants	6 participants	6 participants	16 participants	32 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 16.7%	2 33.3%	5 31.3%	8 25.0%
	>=65 years	1 100.0%	1 100.0%	1 100.0%	1 100.0%	5 83.3%	4 66.7%	11 68.8%	24 75.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants	1 participants	1 participants	1 participants	6 participants	6 participants	16 participants	32 participants
	Female	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Male	1 100.0%	1 100.0%	1 100.0%	1 100.0%	6 100.0%	6 100.0%	16 100.0%	32 100.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants	1 participants	1 participants	1 participants	6 participants	6 participants	16 participants	32 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	1 100.0%	1 100.0%	1 100.0%	1 100.0%	6 100.0%	6 100.0%	16 100.0%	32 100.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants	1 participants	1 participants	1 participants	6 participants	6 participants	16 participants	32 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 16.7%	0 0.0%	0 0.0%	1 3.1%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 6.3%	1 3.1%
	White	1 100.0%	1 100.0%	1 100.0%	1 100.0%	5 83.3%	6 100.0%	15 93.8%	30 93.8%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Dose Limiting Toxicities (DLT)
Description	Count of participants will be measured by the recommended phase II dose in utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for DLTs.
Time Frame	Assessed from start of treatment to up to 8 weeks after first study drug administration.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	225Ac-J591 Cohort 1	225Ac-J591 Cohort 2	225Ac-J591 Cohort 3	225Ac-J591 Cohort 4	225Ac-J591 Cohort 5	225Ac-J591 Cohort 6	225Ac-J591 Cohort 7
Arm/Group Description:	Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment	Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 7: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.
Overall Number of Participants Analyzed	1	1	1	1	6	6	6
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 16.7%	0 0.0%

2. Primary Outcome

Title	Number of Subjects Who Reached Maximum Tolerated Dose (MTD)
Description	The MTD is the highest dose amongst the different dose-level cohorts in this study at which no more than 2 (33%) of the subjects in a cohort experience DLT.
Time Frame	Assessed from start of treatment to up to 8 weeks after first study drug administration.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	225Ac-J591 Cohort 1	225Ac-J591 Cohort 2	225Ac-J591 Cohort 3	225Ac-J591 Cohort 4	225Ac-J591 Cohort 5	225Ac-J591 Cohort 6	225Ac-J591 Cohort 7
Arm/Group Description:	Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment	Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 7 with Expansion: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.
Overall Number of Participants Analyzed	1	1	1	1	6	6	16
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

3. Secondary Outcome

Title	Number of Subjects With Prostate Specific Antigen (PSA) Response
Description	PSA will be analyzed through blood specimen collection
Time Frame	PSA was assessed at screening, and up to 6 months after first treatment with study drug.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	225Ac-J591 Cohort 1	225Ac-J591 Cohort 2	225Ac-J591 Cohort 3	225Ac-J591 Cohort 4	225Ac-J591 Cohort 5	225Ac-J591 Cohort 6	225Ac-J591 Cohort 7
Arm/Group Description:	Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment	Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 7 with Expansion: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.
Overall Number of Participants Analyzed	1	1	1	1	6	6	16
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	1 100.0%	1 100.0%	0 0.0%	3 50.0%	3 50.0%	10 62.5%

4. Secondary Outcome

Title	Number of Subjects With Circulating Tumor Cells (CTC) Response
Description	CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing
Time Frame	CTC was assessed at screening and 12 weeks after starting study drug.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	225Ac-J591 Cohort 1	225Ac-J591 Cohort 2	225Ac-J591 Cohort 3	225Ac-J591 Cohort 4	225Ac-J591 Cohort 5	225Ac-J591 Cohort 6	225Ac-J591 Cohort 7
Arm/Group Description:	Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment	Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 7 with Expansion: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.
Overall Number of Participants Analyzed	1	1	1	1	6	6	16
Measure Type: Count of Participants; Unit of Measure: Participants
	1 100.0%	1 100.0%	1 100.0%	1 100.0%	5 83.3%	5 83.3%	8 50.0%

5. Secondary Outcome

Title	Number of Subjects With Radiographic (Imaging) Response
Description	Radiographic response rate by Response evaluation criteria in solid tumors (RECIST) criteria with Prostate Cancer Working Group 3 (PCWG3) modifications
Time Frame	Response were assessed for patients throughout their duration on the study, up to 3 years.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	225Ac-J591 Cohort 1	225Ac-J591 Cohort 2	225Ac-J591 Cohort 3	225Ac-J591 Cohort 4	225Ac-J591 Cohort 5	225Ac-J591 Cohort 6	225Ac-J591 Cohort 7
Arm/Group Description:	Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment	Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 7 with Expansion: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.
Overall Number of Participants Analyzed	1	1	1	1	6	6	16
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 16.7%	0 0.0%	0 0.0%

6. Secondary Outcome

Title	Progression Free Survival (PFS)
Description	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame	From the start of treatment to progression, up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	225Ac-J591 Cohort 1	225Ac-J591 Cohort 2	225Ac-J591 Cohort 3	225Ac-J591 Cohort 4	225Ac-J591 Cohort 5	225Ac-J591 Cohort 6	225Ac-J591 Cohort 7
Arm/Group Description:	Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment	Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.	Cohort 7 with Expansion: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.
Overall Number of Participants Analyzed	1	1	1	1	6	6	16
Median (Full Range); Unit of Measure: Days
	381; (381 to 381)	56; (56 to 56)	141; (141 to 141)	60; (60 to 60)	366; (95 to 940)	242; (84 to 777)	130; (54 to 334)

Adverse Events

Time Frame

Assessed throughout duration of participant on study, up to 3 years.

Adverse Event Reporting Description

[Not Specified]

Arm/Group Title

225Ac-J591 Cohort 1

225Ac-J591 Cohort 2

225Ac-J591 Cohort 3

225Ac-J591 Cohort 4

225Ac-J591 Cohort 5

225Ac-J591 Cohort 6

225Ac-J591 Cohort 7

Arm/Group Description

Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment

Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.

Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.

Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.

Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.

Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.

Cohort 7 with Expansion: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.

All-Cause Mortality

225Ac-J591 Cohort 1

225Ac-J591 Cohort 2

225Ac-J591 Cohort 3

225Ac-J591 Cohort 4

225Ac-J591 Cohort 5

225Ac-J591 Cohort 6

225Ac-J591 Cohort 7

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

1/1 (100.00%)

1/1 (100.00%)

1/1 (100.00%)

1/1 (100.00%)

5/6 (83.33%)

3/6 (50.00%)

15/16 (93.75%)

Serious Adverse Events

225Ac-J591 Cohort 1

225Ac-J591 Cohort 2

225Ac-J591 Cohort 3

225Ac-J591 Cohort 4

225Ac-J591 Cohort 5

225Ac-J591 Cohort 6

225Ac-J591 Cohort 7

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

0/1 (0.00%)

0/1 (0.00%)

0/1 (0.00%)

0/1 (0.00%)

3/6 (50.00%)

2/6 (33.33%)

8/16 (50.00%)

Blood and lymphatic system disorders

Thrombocytopenia † 1

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/6 (0.00%)

0

1/6 (16.67%)

1

2/16 (12.50%)

2

Anemia † 1

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/6 (0.00%)

0

1/6 (16.67%)

1

2/16 (12.50%)

2

Neutropenia † 1

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

1/6 (16.67%)

1

0/6 (0.00%)

0

1/16 (6.25%)

1

Blood bilirubin Increased † 1

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

1/16 (6.25%)

1

Gastrointestinal disorders

Abdominal Pain † 1

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

1/16 (6.25%)

1

Nervous system disorders

Any Pain † 1

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

1/16 (6.25%)

1

Respiratory, thoracic and mediastinal disorders

Dyspnea † 1

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

2/6 (33.33%)

2

0/6 (0.00%)

0

0/16 (0.00%)

0

1 Term from vocabulary, CTCAE 4.0; † Indicates events were collected by systematic assessment

Other (Not Including Serious) Adverse Events

Frequency Threshold for Reporting Other Adverse Events

5%

225Ac-J591 Cohort 1

225Ac-J591 Cohort 2

225Ac-J591 Cohort 3

225Ac-J591 Cohort 4

225Ac-J591 Cohort 5

225Ac-J591 Cohort 6

225Ac-J591 Cohort 7

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

1/1 (100.00%)

1/1 (100.00%)

1/1 (100.00%)

1/1 (100.00%)

6/6 (100.00%)

6/6 (100.00%)

16/16 (100.00%)

Blood and lymphatic system disorders

Neutropenia † 1

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

1/1 (100.00%)

1

1/6 (16.67%)

1

2/6 (33.33%)

2

7/16 (43.75%)

7

Anemia † 1

1/1 (100.00%)

1

1/1 (100.00%)

1

1/1 (100.00%)

1

1/1 (100.00%)

1

3/6 (50.00%)

3

5/6 (83.33%)

5

7/16 (43.75%)

7

Thrombocytopenia † 1

0/1 (0.00%)

0

1/1 (100.00%)

1

1/1 (100.00%)

1

1/1 (100.00%)

1

4/6 (66.67%)

4

6/6 (100.00%)

6

12/16 (75.00%)

12

Transaminase † 1

0/1 (0.00%)

0

0/1 (0.00%)

0

1/1 (100.00%)

1

0/1 (0.00%)

0

1/6 (16.67%)

1

0/6 (0.00%)

0

2/16 (12.50%)

2

Hypocalcemia † 1

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/6 (0.00%)

0

1/6 (16.67%)

1

0/16 (0.00%)

0

Increased bilirubin † 1

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

1/16 (6.25%)

1

Ear and labyrinth disorders

Dizziness † 1

1/1 (100.00%)

1

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

3/6 (50.00%)

3

0/6 (0.00%)

0

3/16 (18.75%)

3

Gastrointestinal disorders

Nausea † 1

1/1 (100.00%)

1

1/1 (100.00%)

1

0/1 (0.00%)

0

0/1 (0.00%)

0

4/6 (66.67%)

4

6/6 (100.00%)

6

5/16 (31.25%)

5

General disorders

Pain † 1

1/1 (100.00%)

1

1/1 (100.00%)

1

1/1 (100.00%)

1

1/1 (100.00%)

1

3/6 (50.00%)

3

4/6 (66.67%)

4

6/16 (37.50%)

6

Xerostomia † 1

1/1 (100.00%)

1

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

4/6 (66.67%)

4

6/6 (100.00%)

6

5/16 (31.25%)

5

Fatigue † 1

1/1 (100.00%)

1

1/1 (100.00%)

1

1/1 (100.00%)

1

1/1 (100.00%)

1

6/6 (100.00%)

6

6/6 (100.00%)

6

15/16 (93.75%)

15

Dyspnea † 1

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

1/6 (16.67%)

1

2/6 (33.33%)

2

3/16 (18.75%)

3

Confusion † 1

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

1/16 (6.25%)

1

Metabolism and nutrition disorders

Anorexia † 1

1/1 (100.00%)

1

1/1 (100.00%)

1

0/1 (0.00%)

0

1/1 (100.00%)

1

6/6 (100.00%)

6

5/6 (83.33%)

5

8/16 (50.00%)

8

Weight loss † 1

1/1 (100.00%)

1

0/1 (0.00%)

0

0/1 (0.00%)

0

1/1 (100.00%)

1

2/6 (33.33%)

2

1/6 (16.67%)

1

4/16 (25.00%)

4

Musculoskeletal and connective tissue disorders

Generalized muscle soreness † 1

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/1 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

1/16 (6.25%)

1

1 Term from vocabulary, CTCAE 4.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Scott Tagawa
• Organization: Weill Cornell Medicine
• Phone: 646-962-2027
• EMail: stt2007@med.cornell.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vlachostergios PJ, Niaz MJ, Skafida M, Mosallaie SA, Thomas C, Christos PJ, Osborne JR, Molina AM, Nanus DM, Bander NH, Tagawa ST. Imaging expression of prostate-specific membrane antigen and response to PSMA-targeted beta-emitting radionuclide therapies in metastatic castration-resistant prostate cancer. Prostate. 2021 Apr;81(5):279-285. doi: 10.1002/pros.24104. Epub 2021 Jan 19.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03276572
• Other Study ID Numbers: 1706018281; 7R01CA207645-03 ( U.S. NIH Grant/Contract )
• First Submitted: August 3, 2017
• First Posted: September 8, 2017
• Results First Submitted: September 27, 2022
• Results First Posted: December 6, 2022
• Last Update Posted: December 6, 2022