Trial Outcomes & Findings for An Absorption, Distribution, Metabolism, Excretion (ADME) Study of [14C]Subasumstat in Adults With Advanced or Metastatic Solid Tumors (NCT NCT05976334)

NCT ID: NCT05976334

Last Updated: 2025-10-06

Results Overview

Cumulative percentage of \[14C\]-radioactivity excreted in urine up to the last sampling interval.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 3 participants
• Primary outcome timeframe: Up to 14 days post-dose
• Results posted on: 2025-10-06

Participant Flow

3 participants took part in the study at 1 investigative site in Hungary from 14 November 2023 to 16 July 2024.

Participants with advanced or metastatic solid tumors were enrolled in this study to receive [14C] subasumstat in Part A and subasumstat in Part B of this study.

Participant milestones

Measure	Part A: [14C] Subasumstat Participants received a single dose of \[14C\] subasumstat 90 milligrams (mg), intravenous (IV) infusion on Day 1 in Part A of the study.	Part B: Subasumstat Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
Part A STARTED	3	0
Part A COMPLETED	3	0
Part A NOT COMPLETED	0	0
Part B STARTED	0	3
Part B COMPLETED	0	0
Part B NOT COMPLETED	0	3

Reasons for withdrawal

Measure	Part A: [14C] Subasumstat Participants received a single dose of \[14C\] subasumstat 90 milligrams (mg), intravenous (IV) infusion on Day 1 in Part A of the study.	Part B: Subasumstat Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
Part B Death	0	1
Part B Study Terminated by Sponsor	0	1
Part B Reason Not Specified	0	1

Baseline Characteristics

An Absorption, Distribution, Metabolism, Excretion (ADME) Study of [14C]Subasumstat in Adults With Advanced or Metastatic Solid Tumors

Baseline characteristics by cohort

Measure	Part A: [14C] Subasumstat n=3 Participants Participants received a single dose of \[14C\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.
Age, Continuous	53.0 years STANDARD_DEVIATION 12.17 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 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	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 14 days post-dose

Population: SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.

Cumulative percentage of [14C]-radioactivity excreted in urine up to the last sampling interval.

Outcome measures

Measure	Part A: [14C] Subasumstat n=3 Participants Participants received a single dose of \[14C\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.	Part B: Subasumstat Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
Cumulative Percentage of Urinary Recovery	8.87 percentage Geometric Coefficient of Variation 34.5	—

PRIMARY outcome

Timeframe: Up to 14 days post-dose

Population: SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.

Cumulative percentage of [14C]-radioactivity excreted in feces up to the last sampling interval.

Outcome measures

Measure	Part A: [14C] Subasumstat n=3 Participants Participants received a single dose of \[14C\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.	Part B: Subasumstat Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
Cumulative Percentage of Fecal Recovery	75.76 percentage Geometric Coefficient of Variation 14.6	—

PRIMARY outcome

Timeframe: Up to 14 days post-dose

Population: SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.

Cumulative percentage of [14C]-radioactivity excreted in urine, and feces up to the last sampling interval.

Outcome measures

Measure	Part A: [14C] Subasumstat n=3 Participants Participants received a single dose of \[14C\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.	Part B: Subasumstat Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
Cumulative Percentage of Combined Recovery	85.27 percentage Geometric Coefficient of Variation 10.8	—

PRIMARY outcome

Timeframe: Post-dose Day 1: 0-6 hours (hr), 6-12 hr, Day 2: 12-24 hr, Day 3: 24-48 hr, Day 4: 48-72, Day 5: 72-96 hr, Day 6: 96-120 hr, Day 7: 120-144 hr, Day 8: 144-168 hr, Day 9: 168-192 hr, Day 10: 192-216 hr, Day 11: 216-240 hr, Day 12: 240-264 hr

Population: SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug. Number analyzed is the number of participants with data available for analyses at the specified time points.

Percentage of recovered TRA in urine for each interval over the entire period of collection were reported.

Outcome measures

Measure	Part A: [14C] Subasumstat n=3 Participants Participants received a single dose of \[14C\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.	Part B: Subasumstat Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
Percentage Of Recovered Total Radioactivity (TRA) In Urine Day 11- 216-240 hr	NA mg Geometric Coefficient of Variation NA Geometric mean and %CV were not estimable for dataset containing a data point that equalled zero.	—
Percentage Of Recovered Total Radioactivity (TRA) In Urine Day 12- 240-264 hr	NA mg Geometric Coefficient of Variation NA Geometric mean and %CV were not estimable for dataset containing a data point that equalled zero.	—
Percentage Of Recovered Total Radioactivity (TRA) In Urine Day 1- 0-6 hr	6.11 mg Geometric Coefficient of Variation 41.4	—
Percentage Of Recovered Total Radioactivity (TRA) In Urine Day 1- 6-12 hr	0.89 mg Geometric Coefficient of Variation 36.9	—
Percentage Of Recovered Total Radioactivity (TRA) In Urine Day 2- 12-24 hr	0.75 mg Geometric Coefficient of Variation 31.8	—
Percentage Of Recovered Total Radioactivity (TRA) In Urine Day 3- 24-48 hr	0.47 mg Geometric Coefficient of Variation 82.6	—
Percentage Of Recovered Total Radioactivity (TRA) In Urine Day 4- 48-72 hr	0.18 mg Geometric Coefficient of Variation 74.0	—
Percentage Of Recovered Total Radioactivity (TRA) In Urine Day 5- 72-96 hr	0.09 mg Geometric Coefficient of Variation 52.4	—
Percentage Of Recovered Total Radioactivity (TRA) In Urine Day 6- 96-120 hr	0.05 mg Geometric Coefficient of Variation 50.4	—
Percentage Of Recovered Total Radioactivity (TRA) In Urine Day 7- 120-144 hr	0.03 mg Geometric Coefficient of Variation 48.5	—
Percentage Of Recovered Total Radioactivity (TRA) In Urine Day 8- 144-168 hr	0.03 mg Geometric Coefficient of Variation 42.1	—
Percentage Of Recovered Total Radioactivity (TRA) In Urine Day 9- 168-192 hr	0.02 mg Geometric Coefficient of Variation NA Geometric coefficient of variation (%CV) was not estimable for a single participant.	—
Percentage Of Recovered Total Radioactivity (TRA) In Urine Day 10- 192-216 hr	NA mg Geometric Coefficient of Variation NA Geometric mean and %CV were not estimable for dataset containing a data point that equalled zero.	—

PRIMARY outcome

Timeframe: Post-dose Day 1: 0-6 hours hr, 6-12 hr, Day 2: 12-24 hr, Day 3: 24-48 hr, Day 4: 48-72 hr, Day 5: 72-96 hr, Day 6: 96-120 hr, Day 7: 120-144 hr, Day 8: 144-168 hr, Day 9: 168-192 hr, Day 10: 192-216 hr, Day 11: 216-240 hr

Population: SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug. Number analyzed is the number of participants with data available for analyses at the specified time points.

Percentage of recovered TRA in feces for each interval over the entire period of collection were reported.

Outcome measures

Measure	Part A: [14C] Subasumstat n=3 Participants Participants received a single dose of \[14C\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.	Part B: Subasumstat Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
Percentage Of Recovered Total Radioactivity (TRA) In Feces Day 1- 0-24 hr	0.06 mg Geometric Coefficient of Variation NA %CV was not estimable for a single participant.	—
Percentage Of Recovered Total Radioactivity (TRA) In Feces Day 3- 24-48 hr	0.54 mg Geometric Coefficient of Variation 131.6	—
Percentage Of Recovered Total Radioactivity (TRA) In Feces Day 4- 48-72 hr	63.35 mg Geometric Coefficient of Variation 19.5	—
Percentage Of Recovered Total Radioactivity (TRA) In Feces Day 5- 72-96 hr	12.92 mg Geometric Coefficient of Variation NA %CV was not estimable for a single participant.	—
Percentage Of Recovered Total Radioactivity (TRA) In Feces Day 6- 96-120 hr	4.82 mg Geometric Coefficient of Variation 62.4	—
Percentage Of Recovered Total Radioactivity (TRA) In Feces Day 7- 120-144 hr	0.32 mg Geometric Coefficient of Variation 130.0	—
Percentage Of Recovered Total Radioactivity (TRA) In Feces Day 8- 144-168 hr	0.26 mg Geometric Coefficient of Variation 55.3	—
Percentage Of Recovered Total Radioactivity (TRA) In Feces Day 9- 168-192 hr	0.47 mg Geometric Coefficient of Variation NA %CV was not estimable for a single participant.	—
Percentage Of Recovered Total Radioactivity (TRA) In Feces Day 10- 192-216 hr	0.16 mg Geometric Coefficient of Variation NA %CV was not estimable for a single participant.	—
Percentage Of Recovered Total Radioactivity (TRA) In Feces Day 11- 216-240 hr	0.15 mg Geometric Coefficient of Variation NA %CV was not estimable for a single participant.	—

SECONDARY outcome

Timeframe: Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr

Population: The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr

Population: The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr

Population: The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr

Population: The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr

Population: The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr

Population: The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr 4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr

Population: The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose and post-dose at 0-6 hours (hr) and 6-12 hr on Day 1, 12-24 hr on Day 2, 24-48 hr on Day 3, 48-72 hr on Day 4, 72-96 hr on Day 5 up to Day 14

Population: SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.

Cumulative amount of unchanged subasumstat was determined as percentage (%) of dose of subasumstat.

Outcome measures

Measure	Part A: [14C] Subasumstat n=3 Participants Participants received a single dose of \[14C\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.	Part B: Subasumstat Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
Cumulative Amount of Unchanged Subasumstat Excreted Into the Urine (Aeurine)	8.9 % of dose Standard Deviation 2.8	—

SECONDARY outcome

Timeframe: Pre-dose and post-dose at 0-6 hours (hr) and 6-12 hr on Day 1, 12-24 hr on Day 2, 24-48 hr on Day 3, 48-72 hr on Day 4, 72-96 hr on Day 5 up to Day 14

Population: Based on Primary Analysis results, lack of generalizability and accuracy of the urine analysis and missing data for relevant PK parameters, it would not have been possible to report the accurate data without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 8 months

Population: SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.

An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.

Outcome measures

Measure	Part A: [14C] Subasumstat n=3 Participants Participants received a single dose of \[14C\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.	Part B: Subasumstat n=2 Participants Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)	3 participants	2 participants

SECONDARY outcome

Timeframe: Up to approximately 8 months

Population: SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.

Outcome measures

Measure	Part A: [14C] Subasumstat n=3 Participants Participants received a single dose of \[14C\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.	Part B: Subasumstat n=2 Participants Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
Number of Participants With One or More Serious Adverse Events (SAEs)	0 participants	1 participants

SECONDARY outcome

Timeframe: Up to approximately 8 months

Population: SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.

Abnormal laboratory values are those outside of normal range as assessed by the investigator.

Outcome measures

Measure	Part A: [14C] Subasumstat n=3 Participants Participants received a single dose of \[14C\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.	Part B: Subasumstat n=2 Participants Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
Number of Participants With Abnormal Electrocardiogram Findings	1 participants	2 participants

SECONDARY outcome

Timeframe: Up to approximately 8 months

Population: SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.

Laboratory findings will include serum chemistry, hematology and urinalysis. Abnormal laboratory values are those outside of normal range as assessed by the investigator.

Outcome measures

Measure	Part A: [14C] Subasumstat n=3 Participants Participants received a single dose of \[14C\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.	Part B: Subasumstat n=2 Participants Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
Number of Participants With Abnormal Laboratory Values Serum Chemistry	3 participants	2 participants
Number of Participants With Abnormal Laboratory Values Hematology	3 participants	2 participants
Number of Participants With Abnormal Laboratory Values Urinalysis	0 participants	1 participants

SECONDARY outcome

Timeframe: Pre-dose and Post-dose Day 1: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr and Day 8: 168 hr

Population: The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose and Post-dose Day 1: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr and Day 8: 168 hr

Population: SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.

Outcome measures

Measure	Part A: [14C] Subasumstat n=3 Participants Participants received a single dose of \[14C\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.	Part B: Subasumstat Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
Relative Percentage Excretory Metabolites in Urine	0.0 % of dose Standard Deviation 0.0	—

SECONDARY outcome

Timeframe: Pre-dose and Post-dose Day 1: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr and Day 8: 168 hr

Population: SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.

M1, M9 and M10 reported as categories were the names for the metabolites.

Outcome measures

Measure	Part A: [14C] Subasumstat n=3 Participants Participants received a single dose of \[14C\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.	Part B: Subasumstat Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
Relative Percentage of Excretory Metabolites in Feces Metabolite: M1	6.9 % of dose Standard Deviation 1.4	—
Relative Percentage of Excretory Metabolites in Feces Metabolite: M9	2.5 % of dose Standard Deviation 4.3	—
Relative Percentage of Excretory Metabolites in Feces Metabolite: M10	12.3 % of dose Standard Deviation 2.6	—

Adverse Events

[14C] Subasumstat

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Subasumstat

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	[14C] Subasumstat n=3 participants at risk Participants received a single dose of \[14C\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.	Subasumstat n=2 participants at risk Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
General disorders General physical health deterioration	0.00% 0/3 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.	50.0% 1/2 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.

Other adverse events

Measure	[14C] Subasumstat n=3 participants at risk Participants received a single dose of \[14C\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.	Subasumstat n=2 participants at risk Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.	0.00% 0/2 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.	50.0% 1/2 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.	50.0% 1/2 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Headache	66.7% 2/3 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.	100.0% 2/2 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Nausea	66.7% 2/3 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.	0.00% 0/2 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Oral herpes	33.3% 1/3 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.	0.00% 0/2 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.	50.0% 1/2 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.
Vascular disorders Peripheral venous disease	33.3% 1/3 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.	0.00% 0/2 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.	50.0% 1/2 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.
General disorders Pyrexia	66.7% 2/3 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.	100.0% 2/2 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Vomiting	66.7% 2/3 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.	50.0% 1/2 • Up to approximately 8 months SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: TrialDisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place