Trial Outcomes & Findings for LUMINOS-103: A Basket Trial of Safety & Efficacy of Lerapolturev With or Without Checkpoint Inhibitors (NCT NCT04690699)

Last Updated: 2024-10-24

Results Overview

To evaluate the safety and tolerability of lerapolturev monotherapy administered by intravesical instillation to patients with recurrent NMIBC intended for TURBT or cystectomy

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

1 month

Results posted on

2024-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort E: Lerapolturev Subjects will be treated with lerapolturev by intravesical instillation Lerapolturev: Lerapolturev administered via intravesical instillation once	Cohort F: Lerapolturev + 5% DDM Subjects will be treated with lerapolturev by intravesical instillation after a sequence of 5% DDM and saline washes Lerapolturev: Lerapolturev administered via intravesical instillation once 5% DDM: 5% DDM and saline washes
Overall Study STARTED	4	0
Overall Study COMPLETED	4	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LUMINOS-103: A Basket Trial of Safety & Efficacy of Lerapolturev With or Without Checkpoint Inhibitors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort E: Lerapolturev n=4 Participants Subjects will be treated with lerapolturev by intravesical instillation Lerapolturev: Lerapolturev administered via intravesical instillation once	Cohort F: Lerapolturev + 5% DDM Subjects will be treated with lerapolturev by intravesical instillation after a sequence of 5% DDM and saline washes Lerapolturev: Lerapolturev administered via intravesical instillation once 5% DDM: 5% DDM and saline washes	Total n=4 Participants Total of all reporting groups
Age, Continuous	75.5 years n=99 Participants	—	75.5 years n=206 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	—	1 Participants n=206 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	—	3 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=99 Participants	—	4 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	—	1 Participants n=206 Participants
Race (NIH/OMB) White	3 Participants n=99 Participants	—	3 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Region of Enrollment United States	4 participants n=99 Participants	—	4 participants n=206 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Study closed prior to meeting enrollment goal due to business decision

To evaluate the safety and tolerability of lerapolturev monotherapy administered by intravesical instillation to patients with recurrent NMIBC intended for TURBT or cystectomy

Outcome measures

Outcome measures
Measure	Cohort E: Lerapolturev n=4 Participants Subjects will be treated with lerapolturev by intravesical instillation Lerapolturev: Lerapolturev administered via intravesical instillation once	Cohort F: Lerapolturev + 5% DDM Subjects will be treated with lerapolturev by intravesical instillation after a sequence of 5% DDM and saline washes Lerapolturev: Lerapolturev administered via intravesical instillation once 5% DDM: 5% DDM and saline washes
Number of Participants Who Underwent TURBT or Cystectomy as Scheduled	4 Participants	0 Participants

Adverse Events

Cohort E: Lerapolturev

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort F: Lerapolturev + 5% DDM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort E: Lerapolturev n=4 participants at risk Subjects will be treated with lerapolturev by intravesical instillation Lerapolturev: Lerapolturev administered via intravesical instillation once	Cohort F: Lerapolturev + 5% DDM Subjects will be treated with lerapolturev by intravesical instillation after a sequence of 5% DDM and saline washes Lerapolturev: Lerapolturev administered via intravesical instillation once 5% DDM: 5% DDM and saline washes
Infections and infestations Urinary tract infection	25.0% 1/4 • Number of events 1 • up to 30 days post-dose AE were determined by investigator assessment, laboratory evaluation, and patient self-reporting. All AE were graded per NCI CTCAE v5.	— 0/0 • up to 30 days post-dose AE were determined by investigator assessment, laboratory evaluation, and patient self-reporting. All AE were graded per NCI CTCAE v5.
Investigations Alanine aminotransferase increased	25.0% 1/4 • Number of events 1 • up to 30 days post-dose AE were determined by investigator assessment, laboratory evaluation, and patient self-reporting. All AE were graded per NCI CTCAE v5.	— 0/0 • up to 30 days post-dose AE were determined by investigator assessment, laboratory evaluation, and patient self-reporting. All AE were graded per NCI CTCAE v5.
Investigations Aspartate aminotransferase increased	25.0% 1/4 • Number of events 1 • up to 30 days post-dose AE were determined by investigator assessment, laboratory evaluation, and patient self-reporting. All AE were graded per NCI CTCAE v5.	— 0/0 • up to 30 days post-dose AE were determined by investigator assessment, laboratory evaluation, and patient self-reporting. All AE were graded per NCI CTCAE v5.
Renal and urinary disorders Dysuria	50.0% 2/4 • Number of events 2 • up to 30 days post-dose AE were determined by investigator assessment, laboratory evaluation, and patient self-reporting. All AE were graded per NCI CTCAE v5.	— 0/0 • up to 30 days post-dose AE were determined by investigator assessment, laboratory evaluation, and patient self-reporting. All AE were graded per NCI CTCAE v5.
Renal and urinary disorders Pollakiuria	50.0% 2/4 • Number of events 2 • up to 30 days post-dose AE were determined by investigator assessment, laboratory evaluation, and patient self-reporting. All AE were graded per NCI CTCAE v5.	— 0/0 • up to 30 days post-dose AE were determined by investigator assessment, laboratory evaluation, and patient self-reporting. All AE were graded per NCI CTCAE v5.
Renal and urinary disorders Urinary hesitation	25.0% 1/4 • Number of events 1 • up to 30 days post-dose AE were determined by investigator assessment, laboratory evaluation, and patient self-reporting. All AE were graded per NCI CTCAE v5.	— 0/0 • up to 30 days post-dose AE were determined by investigator assessment, laboratory evaluation, and patient self-reporting. All AE were graded per NCI CTCAE v5.

Additional Information

Head of Clinical Operations

Istari Oncology

Phone: 919-245-7662

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60