Trial Outcomes & Findings for Phase I Trial of 225Ac-J591 in Patients With mCRPC (NCT NCT03276572)
NCT ID: NCT03276572
Last Updated: 2024-06-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Assessed from start of treatment to up to 8 weeks after first study drug administration.
Results posted on
2024-06-13
Participant Flow
Recruitment took place at at Weill Cornell Medicine New York Presbyterian and Tulane Medical Center.
Participant milestones
| Measure |
225Ac-J591 Cohort 1
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
|
225Ac-J591 Cohort 2
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.
|
225Ac-J591 Cohort 3
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.
|
225Ac-J591 Cohort 4
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.
|
225Ac-J591 Cohort 5
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.
|
225Ac-J591 Cohort 6
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.
|
225Ac-J591 Cohort 7
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 Study
STARTED
|
1
|
1
|
1
|
1
|
6
|
6
|
16
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
1
|
6
|
5
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
225Ac-J591 Cohort 1
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
|
225Ac-J591 Cohort 2
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.
|
225Ac-J591 Cohort 3
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.
|
225Ac-J591 Cohort 4
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.
|
225Ac-J591 Cohort 5
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.
|
225Ac-J591 Cohort 6
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.
|
225Ac-J591 Cohort 7
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 Study
In follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Phase I Trial of 225Ac-J591 in Patients With mCRPC
Baseline characteristics by cohort
| Measure |
225Ac-J591 Cohort 1
n=1 Participants
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
|
225Ac-J591 Cohort 2
n=1 Participants
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.
|
225Ac-J591 Cohort 3
n=1 Participants
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.
|
225Ac-J591 Cohort 4
n=1 Participants
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.
|
225Ac-J591 Cohort 5
n=6 Participants
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.
|
225Ac-J591 Cohort 6
n=6 Participants
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.
|
225Ac-J591 Cohort 7
n=16 Participants
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
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
8 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
24 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
32 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
32 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
30 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Assessed from start of treatment to up to 8 weeks after first study drug administration.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.
Outcome measures
| Measure |
225Ac-J591 Cohort 1
n=1 Participants
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
|
225Ac-J591 Cohort 2
n=1 Participants
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.
|
225Ac-J591 Cohort 3
n=1 Participants
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.
|
225Ac-J591 Cohort 4
n=1 Participants
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.
|
225Ac-J591 Cohort 5
n=6 Participants
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.
|
225Ac-J591 Cohort 6
n=6 Participants
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.
|
225Ac-J591 Cohort 7
n=6 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Dose Limiting Toxicities (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Assessed from start of treatment to up to 8 weeks after first study drug administration.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.
Outcome measures
| Measure |
225Ac-J591 Cohort 1
n=1 Participants
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
|
225Ac-J591 Cohort 2
n=1 Participants
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.
|
225Ac-J591 Cohort 3
n=1 Participants
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.
|
225Ac-J591 Cohort 4
n=1 Participants
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.
|
225Ac-J591 Cohort 5
n=6 Participants
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.
|
225Ac-J591 Cohort 6
n=6 Participants
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.
|
225Ac-J591 Cohort 7
n=16 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Who Reached Maximum Tolerated Dose (MTD)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: PSA was assessed at screening, and up to 6 months after first treatment with study drug.PSA will be analyzed through blood specimen collection
Outcome measures
| Measure |
225Ac-J591 Cohort 1
n=1 Participants
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
|
225Ac-J591 Cohort 2
n=1 Participants
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.
|
225Ac-J591 Cohort 3
n=1 Participants
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.
|
225Ac-J591 Cohort 4
n=1 Participants
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.
|
225Ac-J591 Cohort 5
n=6 Participants
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.
|
225Ac-J591 Cohort 6
n=6 Participants
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.
|
225Ac-J591 Cohort 7
n=16 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Prostate Specific Antigen (PSA) Response
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: CTC was assessed at screening and 12 weeks after starting study drug.CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing
Outcome measures
| Measure |
225Ac-J591 Cohort 1
n=1 Participants
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
|
225Ac-J591 Cohort 2
n=1 Participants
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.
|
225Ac-J591 Cohort 3
n=1 Participants
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.
|
225Ac-J591 Cohort 4
n=1 Participants
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.
|
225Ac-J591 Cohort 5
n=6 Participants
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.
|
225Ac-J591 Cohort 6
n=6 Participants
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.
|
225Ac-J591 Cohort 7
n=16 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Circulating Tumor Cells (CTC) Response
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Response were assessed for patients throughout their duration on the study, up to 3 years.Radiographic response rate by Response evaluation criteria in solid tumors (RECIST) criteria with Prostate Cancer Working Group 3 (PCWG3) modifications
Outcome measures
| Measure |
225Ac-J591 Cohort 1
n=1 Participants
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
|
225Ac-J591 Cohort 2
n=1 Participants
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.
|
225Ac-J591 Cohort 3
n=1 Participants
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.
|
225Ac-J591 Cohort 4
n=1 Participants
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.
|
225Ac-J591 Cohort 5
n=6 Participants
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.
|
225Ac-J591 Cohort 6
n=6 Participants
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.
|
225Ac-J591 Cohort 7
n=16 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Radiographic (Imaging) Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the start of treatment to progression, up to 3 yearsProgression 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.
Outcome measures
| Measure |
225Ac-J591 Cohort 1
n=1 Participants
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
|
225Ac-J591 Cohort 2
n=1 Participants
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.
|
225Ac-J591 Cohort 3
n=1 Participants
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.
|
225Ac-J591 Cohort 4
n=1 Participants
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.
|
225Ac-J591 Cohort 5
n=6 Participants
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.
|
225Ac-J591 Cohort 6
n=6 Participants
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.
|
225Ac-J591 Cohort 7
n=16 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
381 Days
Interval 381.0 to 381.0
|
56 Days
Interval 56.0 to 56.0
|
141 Days
Interval 141.0 to 141.0
|
60 Days
Interval 60.0 to 60.0
|
366 Days
Interval 95.0 to 940.0
|
242 Days
Interval 84.0 to 777.0
|
130 Days
Interval 54.0 to 334.0
|
Adverse Events
225Ac-J591 Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
225Ac-J591 Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
225Ac-J591 Cohort 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
225Ac-J591 Cohort 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
225Ac-J591 Cohort 5
Serious events: 3 serious events
Other events: 6 other events
Deaths: 6 deaths
225Ac-J591 Cohort 6
Serious events: 2 serious events
Other events: 6 other events
Deaths: 6 deaths
225Ac-J591 Cohort 7
Serious events: 8 serious events
Other events: 16 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
225Ac-J591 Cohort 1
n=1 participants at risk
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
|
225Ac-J591 Cohort 2
n=1 participants at risk
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.
|
225Ac-J591 Cohort 3
n=1 participants at risk
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.
|
225Ac-J591 Cohort 4
n=1 participants at risk
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.
|
225Ac-J591 Cohort 5
n=6 participants at risk
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.
|
225Ac-J591 Cohort 6
n=6 participants at risk
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.
|
225Ac-J591 Cohort 7
n=16 participants at risk
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.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
16.7%
1/6 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
12.5%
2/16 • Number of events 2 • Assessed throughout duration of participant on study, up to 3 years.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
16.7%
1/6 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
12.5%
2/16 • Number of events 2 • Assessed throughout duration of participant on study, up to 3 years.
|
|
Nervous system disorders
Any Pain
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
6.2%
1/16 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
16.7%
1/6 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
6.2%
1/16 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
33.3%
2/6 • Number of events 2 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/16 • Assessed throughout duration of participant on study, up to 3 years.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
6.2%
1/16 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
|
Blood and lymphatic system disorders
Blood bilirubin Increased
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
6.2%
1/16 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
Other adverse events
| Measure |
225Ac-J591 Cohort 1
n=1 participants at risk
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
|
225Ac-J591 Cohort 2
n=1 participants at risk
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.
|
225Ac-J591 Cohort 3
n=1 participants at risk
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.
|
225Ac-J591 Cohort 4
n=1 participants at risk
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.
|
225Ac-J591 Cohort 5
n=6 participants at risk
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.
|
225Ac-J591 Cohort 6
n=6 participants at risk
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.
|
225Ac-J591 Cohort 7
n=16 participants at risk
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.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
16.7%
1/6 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
33.3%
2/6 • Number of events 2 • Assessed throughout duration of participant on study, up to 3 years.
|
43.8%
7/16 • Number of events 7 • Assessed throughout duration of participant on study, up to 3 years.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
50.0%
3/6 • Number of events 3 • Assessed throughout duration of participant on study, up to 3 years.
|
83.3%
5/6 • Number of events 5 • Assessed throughout duration of participant on study, up to 3 years.
|
43.8%
7/16 • Number of events 7 • Assessed throughout duration of participant on study, up to 3 years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
66.7%
4/6 • Number of events 4 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
6/6 • Number of events 6 • Assessed throughout duration of participant on study, up to 3 years.
|
75.0%
12/16 • Number of events 12 • Assessed throughout duration of participant on study, up to 3 years.
|
|
General disorders
Pain
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
50.0%
3/6 • Number of events 3 • Assessed throughout duration of participant on study, up to 3 years.
|
66.7%
4/6 • Number of events 4 • Assessed throughout duration of participant on study, up to 3 years.
|
37.5%
6/16 • Number of events 6 • Assessed throughout duration of participant on study, up to 3 years.
|
|
General disorders
Xerostomia
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
66.7%
4/6 • Number of events 4 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
6/6 • Number of events 6 • Assessed throughout duration of participant on study, up to 3 years.
|
31.2%
5/16 • Number of events 5 • Assessed throughout duration of participant on study, up to 3 years.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
66.7%
4/6 • Number of events 4 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
6/6 • Number of events 6 • Assessed throughout duration of participant on study, up to 3 years.
|
31.2%
5/16 • Number of events 5 • Assessed throughout duration of participant on study, up to 3 years.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
6/6 • Number of events 6 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
6/6 • Number of events 6 • Assessed throughout duration of participant on study, up to 3 years.
|
93.8%
15/16 • Number of events 15 • Assessed throughout duration of participant on study, up to 3 years.
|
|
Blood and lymphatic system disorders
Transaminase
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
16.7%
1/6 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
12.5%
2/16 • Number of events 2 • Assessed throughout duration of participant on study, up to 3 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
6/6 • Number of events 6 • Assessed throughout duration of participant on study, up to 3 years.
|
83.3%
5/6 • Number of events 5 • Assessed throughout duration of participant on study, up to 3 years.
|
50.0%
8/16 • Number of events 8 • Assessed throughout duration of participant on study, up to 3 years.
|
|
Metabolism and nutrition disorders
Weight loss
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
33.3%
2/6 • Number of events 2 • Assessed throughout duration of participant on study, up to 3 years.
|
16.7%
1/6 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
25.0%
4/16 • Number of events 4 • Assessed throughout duration of participant on study, up to 3 years.
|
|
Ear and labyrinth disorders
Dizziness
|
100.0%
1/1 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
50.0%
3/6 • Number of events 3 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
18.8%
3/16 • Number of events 3 • Assessed throughout duration of participant on study, up to 3 years.
|
|
General disorders
Dyspnea
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
16.7%
1/6 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
33.3%
2/6 • Number of events 2 • Assessed throughout duration of participant on study, up to 3 years.
|
18.8%
3/16 • Number of events 3 • Assessed throughout duration of participant on study, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle soreness
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
6.2%
1/16 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
16.7%
1/6 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/16 • Assessed throughout duration of participant on study, up to 3 years.
|
|
General disorders
Confusion
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
6.2%
1/16 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
|
Blood and lymphatic system disorders
Increased bilirubin
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/1 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
0.00%
0/6 • Assessed throughout duration of participant on study, up to 3 years.
|
6.2%
1/16 • Number of events 1 • Assessed throughout duration of participant on study, up to 3 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place