Trial Outcomes & Findings for Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer (NCT NCT05954143)

NCT ID: NCT05954143

Last Updated: 2025-11-20

Results Overview

Objective Response Rate (ORR) was defined as the proportion of participants with best overall response of confirmed Complete Response (CR) or Partial Response (PR) as determined by the treating Investigator using RECIST v1.1 criteria.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Up to approximately 1 year

Results posted on

2025-11-20

Participant Flow

Participants were enrolled at study sites in the United States and Spain.

Participant milestones

Participant milestones
Measure	BDC-1001 Single Agent Participants received BDC-1001 administered intravenously (IV) every 2 weeks	BDC-1001 in Combination With Pertuzumab Participants received BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.
Overall Study STARTED	6	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	BDC-1001 Single Agent Participants received BDC-1001 administered intravenously (IV) every 2 weeks	BDC-1001 in Combination With Pertuzumab Participants received BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.
Overall Study Progressive Disease	1	0
Overall Study Physician Decision	1	0
Overall Study Study Terminated by Sponsor	2	4
Overall Study Death	1	0
Overall Study Withdrawal by Subject	0	1
Overall Study Other	1	0

Baseline Characteristics

Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BDC-1001 Single Agent n=6 Participants Participants received BDC-1001 administered intravenously (IV) every 2 weeks	BDC-1001 in Combination With Pertuzumab n=5 Participants Participants received BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	5 Participants	3 Participants n=4 Participants	8 Participants n=8 Participants
Age, Categorical >=65 years	1 Participants	2 Participants n=4 Participants	3 Participants n=8 Participants
Sex: Female, Male Female	6 Participants	5 Participants n=4 Participants	11 Participants n=8 Participants
Sex: Female, Male Male	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	1 Participants n=4 Participants	2 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants	4 Participants n=4 Participants	9 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants	0 Participants n=4 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) White	5 Participants	4 Participants n=4 Participants	9 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants n=4 Participants	1 Participants n=8 Participants

PRIMARY outcome

Timeframe: Up to approximately 1 year

Population: Three of the 11 participants did not have response assessments.

Objective Response Rate (ORR) was defined as the proportion of participants with best overall response of confirmed Complete Response (CR) or Partial Response (PR) as determined by the treating Investigator using RECIST v1.1 criteria.

Outcome measures

Outcome measures
Measure	BDC-1001 Single Agent n=4 Participants Participants received BDC-1001 administered intravenously (IV) every 2 weeks	BDC-1001 in Combination With Pertuzumab n=4 Participants Participants received BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.
Objective Response Rate (ORR) Per RECIST v1.1 as Assessed by Investigator	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to approximately 1 year

Population: DOR was not assessed as there were no participants with CR or PR.

Duration of Response (DOR) was calculated for participants who achieved confirmed CR or PR. For such participants, DOR is defined as the duration from the start date of CR or PR (whichever response status is observed first) and subsequently confirmed, to the earliest of documented date of PD per RECIST v 1.1 or death. Of the 8 participants with response assessments, there were no participants with PR or CR. Because there were no responses of PR or CR, the DOR cannot be calculated.

Outcome measures

Outcome measures
Measure	BDC-1001 Single Agent Participants received BDC-1001 administered intravenously (IV) every 2 weeks	BDC-1001 in Combination With Pertuzumab Participants received BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.
Duration of Response (DOR) Per RECIST v1.1 as Assessed by Investigator	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to approximately 1 year

Disease Control Rate (DCR) was the proportion of participants who achieved confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD) lasting 23 or more weeks following the first dose of study treatment.

Outcome measures

Outcome measures
Measure	BDC-1001 Single Agent n=4 Participants Participants received BDC-1001 administered intravenously (IV) every 2 weeks	BDC-1001 in Combination With Pertuzumab n=4 Participants Participants received BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.
Disease Control Rate (DCR) Per RECIST v1.1 as Assessed by Investigator	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to approximately 1 year

Progression-free survival (PFS) was defined as the duration from the date of first study treatment administration (Cycle 1 Day 1) to the earliest date of documented PD per RECIST v1.1 or death. A death was considered a PFS event.

Outcome measures

Outcome measures
Measure	BDC-1001 Single Agent n=6 Participants Participants received BDC-1001 administered intravenously (IV) every 2 weeks	BDC-1001 in Combination With Pertuzumab n=5 Participants Participants received BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.
Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by Investigator	0.986 Months Interval 0.427 to It was not possible to calculate the upper 95% confidence interval due to the insufficient number of participants with events.	1.955 Months Interval 1.183 to It was not possible to calculate the upper 95% confidence interval due to the insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to approximately 1 year

Population: All treated participants are included

Overall Survival (OS) was defined as the duration from the date of first study treatment administration to the date of death, irrespective of cause.

Outcome measures

Outcome measures
Measure	BDC-1001 Single Agent n=6 Participants Participants received BDC-1001 administered intravenously (IV) every 2 weeks	BDC-1001 in Combination With Pertuzumab n=5 Participants Participants received BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.
Overall Survival (OS) Died due to any cause	2 Participants	0 Participants
Overall Survival (OS) Surviving at last contact before data cut off	4 Participants	5 Participants

SECONDARY outcome

Timeframe: Continuously from first dose of study treatment through end of treatment and Safety Follow-Up. Up to approximately 1 year

Treatment Emergent Adverse Events (TEAE) was defined as any AE that started on or after the first administration of study treatment. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Outcome measures

Outcome measures
Measure	BDC-1001 Single Agent n=6 Participants Participants received BDC-1001 administered intravenously (IV) every 2 weeks	BDC-1001 in Combination With Pertuzumab n=5 Participants Participants received BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.
Number of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)	6 Participants	5 Participants

SECONDARY outcome

Timeframe: Continuously from first dose of study treatment through end of treatment and Safety Follow-Up. Up to approximately 1 year.

Treatment Emergent Adverse Events (TEAE) was defined as any AE that started on or after the first administration of study treatment. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Outcome measures

Outcome measures
Measure	BDC-1001 Single Agent n=6 Participants Participants received BDC-1001 administered intravenously (IV) every 2 weeks	BDC-1001 in Combination With Pertuzumab n=5 Participants Participants received BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.
Number of Participants Who Had Any Treatment Emergent Adverse Event (TEAE) Related to Study Treatment	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Continuously from first dose of study treatment through end of treatment and Safety Follow-Up. Up to approximately 1 year.

Treatment Emergent Adverse Events (TEAE) was defined as any AE that started on or after the first administration of study treatment. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. A Serious Adverse Event (SAE) was defined as an AE event that resulted in death, was life-threatening, required or prolongs hospitalization, caused persistent or significant disability or incapacity, resulted in congenital anomalies or birth defects, or was an important medical event.

Outcome measures

Outcome measures
Measure	BDC-1001 Single Agent n=6 Participants Participants received BDC-1001 administered intravenously (IV) every 2 weeks	BDC-1001 in Combination With Pertuzumab n=5 Participants Participants received BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.
Number of Participants With Any Treatment Emergent Serious Adverse Event (SAE) Related to Study Treatment	0 Participants	0 Participants

Adverse Events

BDC-1001 Single Agent

Serious events: 2 serious events

Other events: 6 other events

Deaths: 2 deaths

BDC-1001 in Combination With Pertuzumab

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BDC-1001 Single Agent n=6 participants at risk Participants received BDC-1001 administered intravenously (IV) every 2 weeks	BDC-1001 in Combination With Pertuzumab n=5 participants at risk Participants received BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.
Respiratory, thoracic and mediastinal disorders Pneumonitis	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Bronchospasm	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Infections and infestations Pneumonia	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Nervous system disorders Aphasia	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.

Other adverse events

Other adverse events
Measure	BDC-1001 Single Agent n=6 participants at risk Participants received BDC-1001 administered intravenously (IV) every 2 weeks	BDC-1001 in Combination With Pertuzumab n=5 participants at risk Participants received BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.
Eye disorders Dry eye	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal distension	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	60.0% 3/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Gastrointestinal disorders Dry mouth	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Gastrointestinal disorders Ascites	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Anaemia	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Gastrointestinal disorders Dysphagia	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Gastrointestinal disorders Gastrointestinal sounds abnormal	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	40.0% 2/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
General disorders Chills	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	40.0% 2/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
General disorders Fatigue	50.0% 3/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	60.0% 3/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
General disorders Non-cardiac chest pain	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
General disorders Oedema peripheral	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
General disorders Pain	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Infections and infestations Arthritis infective	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Infections and infestations Skin infection	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Infections and infestations Staphylococcal infection	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Tracheal obstruction	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Investigations Alanine aminotransferase	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Investigations Aspartate aminotransferase	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Investigations Aspartate aminotransferase increased	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Investigations Blood alkaline phosphatase increased	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Investigations Blood bilirubin increased	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Investigations Blood lactate dehydrogenase	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Investigations Blood uric acid increased	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Investigations Lymphocyte count decreased	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperuricaemia	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Vascular disorders Hot flush	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypophosphataemia	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Nervous system disorders Headache	33.3% 2/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	40.0% 2/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Psychiatric disorders Confusional state	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Psychiatric disorders Depression	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Reproductive system and breast disorders Nipple exudate bloody	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 3/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Vascular disorders Cyanosis	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Vascular disorders Embolism	16.7% 1/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	0.00% 0/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Vascular disorders Hypertension	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.	20.0% 1/5 • From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year. The safety population included the participants who received at least one dose of study treatment.

Additional Information

Director of Clinical Development Operations

Bolt Biotherapeutics, Inc.

Phone: 1-650-434-8640

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place