Trial Outcomes & Findings for A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery (NCT NCT05457842)

Last Updated: 2024-11-20

Results Overview

The optimal dose was defined as the dose that provided a better visualization compared with lower doses and a comparable visualization to the next higher dose. In the case where 2 doses performed equally, the lower dose was selected. Cumulative visualization data of the LNs from all treated participants was used for optimal dose determination. The optimal dose was determined by the Visualization Review Committee (VRC) using data from the following assessments: LN tissue visualized (Y/N), visualized tissue is lymphatic in origin based on pathologic confirmation, Likert Scale determination of the intensity of fluorescence, and proportion of identified LN with histopathologic confirmation of LN tissue by ASP5354 compared with standard of care (SOC) treatment.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Day 1

Results posted on

2024-11-20

Participant Flow

Participant with breast cancer or melanoma scheduled to undergo sentinel lymph node (SLN) biopsy.

Female participants ≥ 18 years of age diagnosed with localized breast cancer (stage 0 to 2,N0 and M0) or melanoma (stage 1 to 2, N0 and M0) scheduled to undergo surgical intervention for SLN detection and removal using technetium-99m sulfur colloid (Tc-99mSC) or Lymphoseek as part of standard of care (SOC).

Participant milestones

Participant milestones
Measure	ASP5354 0.2 Milligrams (mg) Participant received a single dose of 0.2 mg intradermal injection of ASP5354 on day 1.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ASP5354 0.2 mg n=1 Participants Participant received a single dose of 0.2 mg intradermal injection of ASP5354 on day 1.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: FAS

Outcome measures

Outcome measures
Measure	ASP5354 0.2 mg n=1 Participants Participant received a single dose of 0.2 mg intradermal injection of ASP5354 on day 1.
Optimal Dose of ASP5354 for Lymph Node (LN) Visualization	NA milligrams (mg) With 1 participant enrolled, the optimal dose could not be recorded.

SECONDARY outcome

Timeframe: Day 1 up to day 10

Population: FAS

The visualization of at least 1 LN with histopathologic confirmation is assessed by using a binary "Yes" or "No" question. Those participants with "Yes" as response was reported.

Outcome measures

Outcome measures
Measure	ASP5354 0.2 mg n=1 Participants Participant received a single dose of 0.2 mg intradermal injection of ASP5354 on day 1.
Percentage of Participants With at Least 1 LN Detected Using ASP5354	100 percentage of participants

SECONDARY outcome

Timeframe: Day 1 up to day 10

Population: FAS

The percentage of identified LN with ASP5354 will be compared with SOC treatment with either Tc-99mSC or Lymphoseek, through histopathologic confirmation.

Outcome measures

Outcome measures
Measure	ASP5354 0.2 mg n=3 lymph nodes Participant received a single dose of 0.2 mg intradermal injection of ASP5354 on day 1.
Percentage of Identified LN Tissue by ASP5354 Compared With SOC Treatment	100.0 percentage of lymph nodes Due to low number of events , upper and lower level of 95% CI were not reported.

SECONDARY outcome

Timeframe: From first dose up to day 10

Population: Safety Analysis Set (SAF): Participant enrolled and received study IP.

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly, or birth defect; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. TEAE was defined as an AE observed after starting administration of the study drug.

Outcome measures

Outcome measures
Measure	ASP5354 0.2 mg n=1 Participants Participant received a single dose of 0.2 mg intradermal injection of ASP5354 on day 1.
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) TEAE	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) SAE	0 Participants

SECONDARY outcome

Timeframe: Predose, approximately 10 minutes, 30 minutes, 60 minutes postdose, and at the end of surgery (day 1)

Population: Pharmacokinetic analysis set: All participants who received at least 1 dose of IP for which at least 1 plasma concentration data were available with the time of dosing and sampling.

Plasma concentration of ASP5354. The Lower limit of quantification (LLOQ) was defined as 1.00 nanograms per milliliter (ng/mL). Measured values below the LLOQ were expressed as \<LLOQ and not reported.

Outcome measures

Outcome measures
Measure	ASP5354 0.2 mg n=1 Participants Participant received a single dose of 0.2 mg intradermal injection of ASP5354 on day 1.
Plasma Concentration of ASP5354 End of surgery post dose	1.21 ng/mL
Plasma Concentration of ASP5354 Predose	NA ng/mL Standard Deviation NA Data was not reported as it was \<LLOQ.
Plasma Concentration of ASP5354 10 minutes post dose	1.13 ng/mL
Plasma Concentration of ASP5354 30 minutes post dose	1.75 ng/mL
Plasma Concentration of ASP5354 60 minutes post dose	1.66 ng/mL

Adverse Events

ASP5354 0.2 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trial Disclosure

Astellas Pharma Global Development, Inc

Phone: 8008887704

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
Publication restrictions are in place

Restriction type: OTHER