Trial Outcomes & Findings for Assessment of Safety, Tolerability, Radiation Dosimetry, Imaging Properties of 89Zr-girentuximab in Patients With NMIBC (NCT NCT04897763)

Results Overview

The presence or absence of uptake spot in bladder wall of 89Zr-girentuximab bladder and whole body PET/CT Images.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

6 participants

Primary outcome timeframe

3 days

Results posted on

2026-01-07

Participant Flow

Study start date First patient was enrolled: 15 DEC 2021 End of trial date (last visit of last patient): 26 SEP 2022

All screened patients have been enrolled

Participant milestones

Participant milestones
Measure	89Zr-TLX250 PET/CT 89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all patients after 89Zr-TLX250 (89Zr-girentuximab) administration
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	89Zr-TLX250 n=6 Participants 89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all patients after 89Zr-TLX250 (89Zr-girentuximab) administration
Age, Categorical <=18 years	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=6 Participants
Age, Categorical >=65 years	6 Participants n=6 Participants
Sex: Female, Male Female	2 Participants n=6 Participants
Sex: Female, Male Male	4 Participants n=6 Participants
Region of Enrollment France	6 Participants n=6 Participants

PRIMARY outcome

Timeframe: 3 days

The presence or absence of uptake spot in bladder wall of 89Zr-girentuximab bladder and whole body PET/CT Images.

Outcome measures

Outcome measures
Measure	89Zr-TLX250 (89Zr-girentuximab) PET/CT n=6 Participants 89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all patients after 89Zr-TLX250 (89Zr-girentuximab) administration
Number of Participants With Uptake Spot in 89Zr-girentuximab PET/CT Images Uptake spot in bladder wall with early recurrence	1 Participants
Number of Participants With Uptake Spot in 89Zr-girentuximab PET/CT Images Uptake spot in bladder wall with post-TURB inflammatory scarring reaction	2 Participants
Number of Participants With Uptake Spot in 89Zr-girentuximab PET/CT Images No uptake spot in bladder wall	3 Participants

PRIMARY outcome

Timeframe: 2 days

89Zr-girentuximab activity dosing in blood is measured. The number of patients with Positive and negative 89Zr-girentuximab Blood dosing is evaluated.

Outcome measures

Outcome measures
Measure	89Zr-TLX250 (89Zr-girentuximab) PET/CT n=6 Participants 89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all patients after 89Zr-TLX250 (89Zr-girentuximab) administration
Number of Patients With Positive and Negative 89Zr-girentuximab Blood Dosing Positive 89Zr-girentuximab Blood dosing	1 Participants
Number of Patients With Positive and Negative 89Zr-girentuximab Blood Dosing Negative 89Zr-girentuximab Blood dosing	5 Participants

SECONDARY outcome

Timeframe: 30 days

Serious adverse events, related or not to 89Zr-girentuximab, are assessed up to Day 30 after 89Zr-girentuximab administration, using CTC-AE scale version 5.0

Outcome measures

Outcome measures
Measure	89Zr-TLX250 (89Zr-girentuximab) PET/CT n=6 Participants 89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all patients after 89Zr-TLX250 (89Zr-girentuximab) administration
Number of Participants With Serious Adverse Events Urinary retention grade 2 not related to 89Zr-TLX250 (89Zr-girentuximab) PET/CT	1 Participants
Number of Participants With Serious Adverse Events Haemorrhage grade 3 not related to 89Zr-TLX250 (89Zr-girentuximab) PET/CT	1 Participants
Number of Participants With Serious Adverse Events No SAE	4 Participants

SECONDARY outcome

Timeframe: 3 months

The expression of CAIX is by immunohistochemistry in tumor sample from TransUrethral Resection of Bladder Tumor (TURBT) or cystectomy

Outcome measures

Outcome measures
Measure	89Zr-TLX250 (89Zr-girentuximab) PET/CT n=6 Participants 89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all patients after 89Zr-TLX250 (89Zr-girentuximab) administration
Number of Patients With Positive and Negative CA-IX Expression in Tumor Cells Negative CA-IX expression in tumor cells	1 Participants
Number of Patients With Positive and Negative CA-IX Expression in Tumor Cells Positive CA-IX expression in tumor cells	5 Participants

SECONDARY outcome

Timeframe: 3 days

Adverse events related to 89Zr-girentuximab are assessed up to Day 3 After 89Zr-girentuximab Administration, using CTC-AE scale version 5.0

Outcome measures

Outcome measures
Measure	89Zr-TLX250 (89Zr-girentuximab) PET/CT n=6 Participants 89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all patients after 89Zr-TLX250 (89Zr-girentuximab) administration
Number of Participants With Adverse Events Related to 89Zr-girentuximab Urethral bleeding grade 1 not related to 89Zr-TLX250 (89Zr-girentuximab) PET/CT	1 Participants
Number of Participants With Adverse Events Related to 89Zr-girentuximab No adverse events	5 Participants

SECONDARY outcome

Timeframe: 3 days

Population: Assessments were conducted on three staff members involved in the administration of 89Zr-TLX250 (89Zr-girentuximab) to determine the presence or absence of staff contamination from the administered radioactivity during patient management.

Radiation exposure of 3 staff membres (extremities and Whole body: µSv). A value greater than 4mSv is considered abnormal.

Outcome measures

Outcome measures
Measure	89Zr-TLX250 (89Zr-girentuximab) PET/CT n=3 Participants 89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all patients after 89Zr-TLX250 (89Zr-girentuximab) administration
Radiation Protection Management Whole body radiation exposure of staff	5.5 µSv Interval 1.0 to 10.0
Radiation Protection Management Extremities radiation exposure of staff	5 µSv Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 1 day

Population: Measurement of radioactivity on the urinary catheter, cotton swabs, diapers, and gloves to assess potential radioactivity contamination.

Radiopharmaceutical management from intravesical instillation to elimination (surfasic contamination measured in counts/second).

Outcome measures

Outcome measures
Measure	89Zr-TLX250 (89Zr-girentuximab) PET/CT n=4 Materials exposed to radioactivity 89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all patients after 89Zr-TLX250 (89Zr-girentuximab) administration
Radiation Protection Management	115 counts per second Interval 50.0 to 180.0

Adverse Events

89Zr-TLX250

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	89Zr-TLX250 n=6 participants at risk 89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all patients after 89Zr-TLX250 (89Zr-girentuximab) administration
Renal and urinary disorders Urinary retention	16.7% 1/6 • Number of events 1 • From the date of administration of 89Zr- Girentuximab until 30 days after administration
Renal and urinary disorders Bladder bleeding	16.7% 1/6 • Number of events 1 • From the date of administration of 89Zr- Girentuximab until 30 days after administration

Other adverse events

Other adverse events
Measure	89Zr-TLX250 n=6 participants at risk 89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all patients after 89Zr-TLX250 (89Zr-girentuximab) administration
Renal and urinary disorders Urethral bleeding	16.7% 1/6 • Number of events 1 • From the date of administration of 89Zr- Girentuximab until 30 days after administration

Additional Information

Dr Caroline ROUSSEAU

Institut de cancérologie de l'Ouest

Phone: +33 2 40 67 99 31

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place