Trial Outcomes & Findings for A Study Of The Safety And Effects Of One Or More Doses Of HSP-130 Injected Under The Skin In Women With Breast Cancer That Has Not Spread To Distant Sites In The Body. (NCT NCT02650193)

Last Updated: 2018-10-23

Results Overview

Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

Results posted on

2018-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.	Cycle 0: HSP-130 3mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 milligram (mg) of HSP-130 subcutaneously (SC) at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.
Overall Study STARTED	13	6	6
Overall Study COMPLETED	13	6	6
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Of The Safety And Effects Of One Or More Doses Of HSP-130 Injected Under The Skin In Women With Breast Cancer That Has Not Spread To Distant Sites In The Body.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg n=13 Participants Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.	Total n=25 Participants Total of all reporting groups
Age, Continuous	66.8 years STANDARD_DEVIATION 8.89 • n=5 Participants	60.8 years STANDARD_DEVIATION 13.60 • n=7 Participants	55.1 years STANDARD_DEVIATION 8.95 • n=5 Participants	59.3 years STANDARD_DEVIATION 10.93 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants	25 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants	21 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 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
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 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
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
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants	24 Participants n=4 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
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

PRIMARY outcome

Timeframe: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Area Under the Effect Curve for Absolute Neutrophil Count (AUECANC): Cycle 0	3900.482 hour*10^9 Neutrophils per Liter Standard Deviation 683.6870	5880.985 hour*10^9 Neutrophils per Liter Standard Deviation 1287.2887	—

PRIMARY outcome

Timeframe: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication.

AUCinf = Area under the serum concentration of HSP-130 versus time curve (AUC) from the time of dose administration to extrapolated infinite time (0-inf).

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0	1425862.2 hourpicogram per milliliter (hpg/mL) Standard Deviation 949518.8	5689476.1 hourpicogram per milliliter (hpg/mL) Standard Deviation 3757035.5	—

PRIMARY outcome

Timeframe: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Maximum Observed Serum Concentration (Cmax): Cycle 0	38026.7 picogram per milliliter (pg/mL) Standard Deviation 28821.7	155766.7 picogram per milliliter (pg/mL) Standard Deviation 99051.8	—

PRIMARY outcome

Timeframe: Cycle 1: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.

Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was \< 0.5 x10\^9 per liter. DSN was defined as the days with grade 4 neutropenia (ANC \< 0.5 x10\^9/L).

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=12 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Duration of Severe Neutropenia (DSN): Cycle 1	0.667 days Standard Deviation 0.9847	—	—

PRIMARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication.

AUC0-t= Area under the serum concentration of HSP-130 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4 Cycle 1	10084193.7 h*pg/mL Standard Deviation 14047222.7	—	—
Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4 Cycle 4	6017621.6 h*pg/mL Standard Deviation 5920395.4	—	—

PRIMARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4 Cycle 1	118130.8 pg/mL Standard Deviation 119028.6	—	—
Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4 Cycle 4	95200.0 pg/mL Standard Deviation 93544.1	—	—

SECONDARY outcome

Timeframe: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.

ANC was a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Maximum Effect for Absolute Neutrophil Count (ANC_Emax): Cycle 0	24.512 *10^9 Neutrophils per Liter Standard Deviation 6.0710	43.257 *10^9 Neutrophils per Liter Standard Deviation 5.5683	—

SECONDARY outcome

Timeframe: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.

ANC was a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Time of Maximum Effect for Absolute Neutrophil Count (ANC_Tmax): Cycle 0	71.950 hour Interval 48.0 to 144.1	47.800 hour Interval 46.9 to 48.3	—

SECONDARY outcome

Timeframe: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Area Under the Effect Curve for CD34+ (AUECCD34+): Cycle 0	1749.523 hourcells per microliter (hcells/ mcL) Standard Deviation 1022.3037	2752.198 hourcells per microliter (hcells/ mcL) Standard Deviation 2152.8794	—

SECONDARY outcome

Timeframe: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Maximum Effect for CD34+ Count (CD34+_Emax): Cycle 0	13.970 cells per microliter (cells/mcL) Standard Deviation 6.8536	27.343 cells per microliter (cells/mcL) Standard Deviation 18.4805	—

SECONDARY outcome

Timeframe: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Time of Maximum Effect for CD34+ Count (CD34+ Tmax): Cycle 0	96.000 hour Interval 48.0 to 96.1	96.600 hour Interval 95.8 to 191.3	—

SECONDARY outcome

Timeframe: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.

ANC is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=5 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Area Under the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC Inf): Cycle 0	5254.288 hour*10^9 Neutrophils per Liter Standard Deviation 1699.7088	6576.165 hour*10^9 Neutrophils per Liter Standard Deviation 1821.9919	—

SECONDARY outcome

Timeframe: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm. Here "Overall number of participants analyzed" signifies number of participants evaluable for the specified outcome measure.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=5 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Area Under the Effect Curve From Time of Dose Administration to Time Infinity for CD34 + (AUEC_CD34+ Inf): Cycle 0	1835.221 hourcells per microliter (hcells/mcL) Standard Deviation 1036.6473	3159.470 hourcells per microliter (hcells/mcL) Standard Deviation 2197.4774	—

SECONDARY outcome

Timeframe: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication.

AUC0-t= Area under the serum concentration of HSP-130 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Area Under the Serum Concentration Time Curve From the Time of Dose Administration to the Time of Last Measurable Concentration (AUCt): Cycle 0	1410202.6 h*pg/mL Standard Deviation 948443.5	5677700.3 h*pg/mL Standard Deviation 3756049.2	—

SECONDARY outcome

Timeframe: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Time To Achieve Maximum Serum Concentration (Tmax): Cycle 0	12.0 hour Interval 12.0 to 12.0	23.5 hour Interval 6.0 to 24.0	—

SECONDARY outcome

Timeframe: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication.

t1/2 is the time taken for plasma concentration of HSP 130 to reduce by 50 percent (%) of its initial value.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Elimination Half-Life (t1/2): Cycle 0	50.0 hour Standard Deviation 15.5	48.8 hour Standard Deviation 12.5	—

SECONDARY outcome

Timeframe: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication.

Elimination rate constant was defined as the rate at which the drug was removed from the body.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Elimination Rate Constant (λz): Cycle 0	0.015 per hour Standard Deviation 0.0051	0.015 per hour Standard Deviation 0.0041	—

SECONDARY outcome

Timeframe: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication.

Clearance of a drug was defined as the rate at which a drug was metabolized or eliminated by normal biological processes.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Apparent Clearance (CL/F): Cycle 0	4235.6 milliliter per hour (mL/h) Standard Deviation 4714.4	1655.9 milliliter per hour (mL/h) Standard Deviation 1242.6	—

SECONDARY outcome

Timeframe: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication.

The protein-content correction was conducted for AUCinf parameter: Protein-content corrected AUCinf = Nominal Protein-content AUCinf / (Actual protein concentration/10.0 mg/mL).

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0	1440264.8 h*pg/mL Standard Deviation 959109.9	5689476.1 h*pg/mL Standard Deviation 3757035.5	—

SECONDARY outcome

Timeframe: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication.

The protein-content correction was conducted for AUCt parameter: Protein-content corrected AUCt= Nominal Protein-content AUCt / (Actual protein concentration/10.0 mg/mL).

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 0	1424447.1 h*pg/mL Standard Deviation 958023.7	5677700.3 h*pg/mL Standard Deviation 3756049.2	—

SECONDARY outcome

Timeframe: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication.

The protein-content correction was conducted for Cmax parameter: Protein-content corrected Cmax = Nominal Protein-content Cmax / (Actual protein concentration/10.0 mg/mL).

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 0	38410.8 pg/mL Standard Deviation 29112.8	155766.7 pg/mL Standard Deviation 99051.8	—

SECONDARY outcome

Timeframe: Cycle 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms. Here, 'Overall number of participants analyzed" signifies number of participants evaluable for the specified outcome measure.

Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was \< 0.5 x10\^9/L. DSN was defined as the days with grade 4 neutropenia (ANC \< 0.5 x10\^9/L).

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=12 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Duration of Severe Neutropenia (DSN): Cycle 4	0.667 days Standard Deviation 0.9847	—	—

SECONDARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.

Nadir was defined as the lowest count for ANC concentration reported after first dose of study treatment.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Absolute Neutrophil Count Nadir Concentration: Cycle 1 and Cycle 4 Cycle 1	1.132 *10^9 Neutrophils per Liter Standard Deviation 1.1480	—	—
Absolute Neutrophil Count Nadir Concentration: Cycle 1 and Cycle 4 Cycle 4	1.623 *10^9 Neutrophils per Liter Standard Deviation 1.8364	—	—

SECONDARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.

Time of ANC Nadir (in hours) was defined as the time from the first dose of study treatment on Day 2 of Cycle 1 and 4 to the time the lowest value was recorded.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Time of ANC Nadir Concentration: Cycle 1 and Cycle 4 Cycle 1	129.231 hour Standard Deviation 23.0585	—	—
Time of ANC Nadir Concentration: Cycle 1 and Cycle 4 Cycle 4	142.154 hour Standard Deviation 65.3323	—	—

SECONDARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.

ANC is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Area Under the Effect Curve (AUEC_ANCt): Cycle 1 and Cycle 4 Cycle 1	2540.285 hour*10^9 Neutrophils per Liter Standard Deviation 854.2237	—	—
Area Under the Effect Curve (AUEC_ANCt): Cycle 1 and Cycle 4 Cycle 4	3186.542 hour*10^9 Neutrophils per Liter Standard Deviation 1362.0079	—	—

SECONDARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. Here, "number analyzed" field signifies that the number of participants were evaluable at specified time point.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Area Under the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC Inf): Cycle 1 and Cycle 4 Cycle 1	5636.963 hour*10^9 Neutrophils per Liter Standard Deviation 1974.1635	—	—
Area Under the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC Inf): Cycle 1 and Cycle 4 Cycle 4	12399.370 hour*10^9 Neutrophils per Liter Standard Deviation 18345.3366	—	—

SECONDARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.

Febrile Neutropenia was defined as tympanic or axillary body temperature greater than (\>) 38.5 °C for \>1 hour and ANC less than (\<) 1.0 \*10\^9/L.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Incidence of Febrile Neutropenia: Cycle 1 and Cycle 4 Cycle 1	1 participants	—	—
Incidence of Febrile Neutropenia: Cycle 1 and Cycle 4 Cycle 4	0 participants	—	—

SECONDARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.

Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was \< 0.5 x10\^9/L.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Incidence of Severe Neutropenia: Cycle 1 and Cycle 4 Cycle 1	5 participants	—	—
Incidence of Severe Neutropenia: Cycle 1 and Cycle 4 Cycle 4	5 participants	—	—

SECONDARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.

Time to ANC recovery was defined as the time from documentation of the first day with ANC greater than equal to (\>=) 2.0 x10\^9/L after any day with ANC \<2.0 x10\^9/L.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Time to ANC Recovery: Cycle 1 and Cycle 4 Cycle 1	2.615 days Standard Deviation 1.7097	—	—
Time to ANC Recovery: Cycle 1 and Cycle 4 Cycle 4	2.000 days Standard Deviation 1.633	—	—

SECONDARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. Here, 'number analyzed' field signifies that the number of participants were evaluable at specified time point.

AUC0-inf = Area under the serum concentration versus time curve (AUC) from the time of dose administration to extrapolated infinite time (0-inf).

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4 Cycle 1	10093213.5 h*pg/mL Standard Deviation 14047936.2	—	—
Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4 Cycle 4	6425013.3 h*pg/mL Standard Deviation 6000938.3	—	—

SECONDARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Time To Achieve Maximum Serum Concentration (Tmax): Cycle 1 and Cycle 4 Cycle 1	24.1 hour Interval 12.0 to 48.0	—	—
Time To Achieve Maximum Serum Concentration (Tmax): Cycle 1 and Cycle 4 Cycle 4	23.5 hour Interval 6.0 to 142.0	—	—

SECONDARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. Here 'number analyzed' signifies number of participants evaluable for this outcome measure at specified time points.

t1/2 is the time taken for plasma concentration of a drug to reduce by 50% of its initial value.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Elimination Half-Life (t1/2): Cycle 1 and Cycle 4 Cycle 1	30.7 hour Standard Deviation 10.8	—	—
Elimination Half-Life (t1/2): Cycle 1 and Cycle 4 Cycle 4	29.5 hour Standard Deviation 9.5	—	—

SECONDARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. Here, 'number analyzed' signifies number of participants evaluable for this outcome measure at specified time points.

Elimination rate constant was defined as the rate at which the drug was removed from the body.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Elimination Rate Constant (λz): Cycle 1 and Cycle 4 Cycle 1	0.026 per hour Standard Deviation 0.0099	—	—
Elimination Rate Constant (λz): Cycle 1 and Cycle 4 Cycle 4	0.025 per hour Standard Deviation 0.0060	—	—

SECONDARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

CL/F was defined as a quantitative measure of the rate at which a drug substance is removed from the body.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Apparent Clearance (CL/F): Cycle 1 and Cycle 4 Cycle 1	1326.8 mL/h Standard Deviation 1010.2	—	—
Apparent Clearance (CL/F): Cycle 1 and Cycle 4 Cycle 4	2342.8 mL/h Standard Deviation 2043.8	—	—

SECONDARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication.

The protein-content correction was conducted for AUCt parameter: Protein-content corrected AUCt= Nominal Protein-content AUCt / (Actual protein concentration/10.0 mg/mL).

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4 Cycle 1	10087666.8 h*pg/mL Standard Deviation 14045724.4	—	—
Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4 Cycle 4	6045733.4 h*pg/mL Standard Deviation 5955438.5	—	—

SECONDARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication. Here 'number analyzed' signifies number of participants evaluable at the specified timepoints only.

The protein-content correction was conducted for AUCinf parameter: Protein-content corrected AUCinf = Nominal Protein-content AUCinf / (Actual protein concentration/10.0 mg/mL).

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4 Cycle 1	10096698.3 h*pg/mL Standard Deviation 14046434.6	—	—
Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4 Cycle 4	6454443.8 h*pg/mL Standard Deviation 6037499.6	—	—

SECONDARY outcome

Timeframe: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Population: FAS included all participants who received at least 1 dose of study medication.

The protein-content correction was conducted for Cmax parameter: Protein-content corrected Cmax = Nominal Protein-content Cmax / (Actual protein concentration/10.0 mg/mL).

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=13 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4 Cycle 1	118173.0 pg/mL Standard Deviation 119004.2	—	—
Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4 Cycle 4	95670.1 pg/mL Standard Deviation 94209.4	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to approximately Day 94

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after the HSP-130 administration up to and including 30 days post HSP-130 administration (up to Day 94). AEs included both serious and non-serious.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg n=13 Participants Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	6 Participants	6 Participants	13 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	0 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to approximately Day 94

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

AEs of Special Interest (AESI) included Potential Allergic Reactions, Splenomegaly, Splenic Rupture, Acute Respiratory Distress Syndrome, Alveolar Hemorrhage, Hemoptysis, Leukocytosis, Thrombocytopenia, Capillary Leak Syndrome, Cytokine Release Syndrome, Cutaneous Vasculitis and Glomerulonephritis.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg n=13 Participants Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Number of Participants With Treatment-Emergent Adverse Events (AEs) of Special Interest	0 Participants	2 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to approximately Day 94

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

Criteria: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, neutrophils); chemistry (alkaline phosphatase, glucose, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase, albumin, creatinine and gamma-glutamyl transpeptidase, blood urea nitrogen, total protein, phosphate, and uric acid); urinalysis. The clinical laboratory results and patterns observed were consistent with the known therapeutic response and the safety profile for the US and EU approved pegylated filgrastim (Neulasta).

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg n=13 Participants Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Number of Participants With Laboratory Abnormalities	6 Participants	6 Participants	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to approximately Day 94

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

Vital sign assessment included body temperature (tympanic or axillary), heart rate (sitting), blood pressure (sitting systolic and diastolic), and respiratory rate. Clinically significant abnormality was based upon investigator's discretion.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg n=13 Participants Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Number of Participants With Clinically Significant Vital Sign Abnormalities	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to approximately Day 94

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

Physical examination included physical assessment of the spleen. Clinically significant abnormality was based on investigator's discretion.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg n=13 Participants Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Number of Participants With Clinically Significant Physical Examination Abnormalities	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to approximately Day 94

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

Clinically significant abnormality was based upon investigator's discretion.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg n=13 Participants Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to approximately Day 94

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg n=13 Participants Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Number of Participants With At Least 1 Concomitant Medication	6 Participants	6 Participants	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to approximately Day 94

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg n=13 Participants Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Duration of Exposure to Study Drug Medication	3.00 days Interval 3.0 to 3.0	6.00 days Interval 6.0 to 6.0	24.0 days Interval 24.0 to 24.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to approximately Day 94

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Cycle 0: HSP-130 3mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 0: HSP-130 6mg n=6 Participants Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycles 1-4: HSP-130 6mg n=13 Participants Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Number of Participants With Positive Anti-pegfilgrastim (Anti-drug) Antibodies	0 Participants	0 Participants	0 Participants

Adverse Events

Cycle 0: HSP-130 3mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cycle 0: HSP-130 6mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cycle 1-4: HSP-130 6mg

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cycle 0: HSP-130 3mg n=6 participants at risk Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycle 0: HSP-130 6mg n=6 participants at risk Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.	Cycle 1-4: HSP-130 6mg n=13 participants at risk Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/6 • Baseline up to approximately Day 94 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/6 • Baseline up to approximately Day 94 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	15.4% 2/13 • Baseline up to approximately Day 94 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Other adverse events

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER