Trial Outcomes & Findings for Her2-BATS and Pembrolizumab in Metastatic Breast Cancer (NCT NCT03272334)

NCT ID: NCT03272334

Last Updated: 2026-02-27

Results Overview

Maximum tolerated dose will be based on number of dose limiting toxicities in each schedule/arm

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

22 participants

Primary outcome timeframe

From start of study treatment until 3 weeks after last dose of study treatment, assessed over about 10 weeks.

Results posted on

2026-02-27

Participant Flow

22 participants were enrolled, but only 17 initiated cellular infusions (study treatment).

Participant milestones

Participant milestones
Measure	Phase 1: Schedule #1 At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 1 infusion of Pembrolizumab in week #7. No interventions within weeks #3 and 4. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 1: Schedule #2 At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 2 infusions of Pembrolizumab; the first given within weeks #3 - 4 and the second in week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 1: Schedule #3 At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 2: Schedule 3 At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab
Overall Study STARTED	3	8	3	8
Overall Study COMPLETED	3	7	3	4
Overall Study NOT COMPLETED	0	1	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1: Schedule #1 At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 1 infusion of Pembrolizumab in week #7. No interventions within weeks #3 and 4. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 1: Schedule #2 At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 2 infusions of Pembrolizumab; the first given within weeks #3 - 4 and the second in week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 1: Schedule #3 At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 2: Schedule 3 At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab
Overall Study never started cellular infusions	0	1	0	4

Baseline Characteristics

Her2-BATS and Pembrolizumab in Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1: Schedule #1 n=3 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 1 infusion of Pembrolizumab in week #7. No interventions within weeks #3 and 4. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 1: Schedule #2 n=8 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 2 infusions of Pembrolizumab; the first given within weeks #3 - 4 and the second in week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 1: Schedule #3 n=3 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 2: Schedule #3 n=8 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Total n=22 Participants Total of all reporting groups
Age, Customized Median (SD)	64.7 years STANDARD_DEVIATION 13.7 • n=24 Participants	51.5 years STANDARD_DEVIATION 16.8 • n=20 Participants	56.2 years STANDARD_DEVIATION 10.2 • n=40 Participants	53.3 years STANDARD_DEVIATION 11.9 • n=565 Participants	54.6 years STANDARD_DEVIATION 13.7 • n=349 Participants
Sex: Female, Male Female	3 Participants n=24 Participants	8 Participants n=20 Participants	3 Participants n=40 Participants	8 Participants n=565 Participants	22 Participants n=349 Participants
Sex: Female, Male Male	0 Participants n=24 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=565 Participants	0 Participants n=349 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=24 Participants	1 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=565 Participants	2 Participants n=349 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=24 Participants	7 Participants n=20 Participants	3 Participants n=40 Participants	7 Participants n=565 Participants	20 Participants n=349 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=565 Participants	0 Participants n=349 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=24 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=565 Participants	0 Participants n=349 Participants
Race (NIH/OMB) Asian	0 Participants n=24 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=565 Participants	0 Participants n=349 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=565 Participants	0 Participants n=349 Participants
Race (NIH/OMB) Black or African American	0 Participants n=24 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=565 Participants	1 Participants n=349 Participants
Race (NIH/OMB) White	3 Participants n=24 Participants	8 Participants n=20 Participants	3 Participants n=40 Participants	7 Participants n=565 Participants	21 Participants n=349 Participants
Race (NIH/OMB) More than one race	0 Participants n=24 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=565 Participants	0 Participants n=349 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=565 Participants	0 Participants n=349 Participants
Region of Enrollment United States	3 participants n=24 Participants	8 participants n=20 Participants	3 participants n=40 Participants	8 participants n=565 Participants	22 participants n=349 Participants
ECOG Performance status	1.2 units on a scale n=24 Participants	1.3 units on a scale n=20 Participants	1.2 units on a scale n=40 Participants	1.2 units on a scale n=565 Participants	1.2 units on a scale n=349 Participants

PRIMARY outcome

Timeframe: From start of study treatment until 3 weeks after last dose of study treatment, assessed over about 10 weeks.

Population: Includes only evaluable participants

Maximum tolerated dose will be based on number of dose limiting toxicities in each schedule/arm

Outcome measures

Outcome measures
Measure	Phase 1: Schedule #1 n=3 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 1 infusion of Pembrolizumab in week #7. No interventions within weeks #3 and 4. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 1: Schedule #2 n=7 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 2 infusions of Pembrolizumab; the first given within weeks #3 - 4 and the second in week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 1: Schedule #3 n=3 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 2: Schedule #3 n=4 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab
Dose Limiting Toxicities (Escalation and Expansion Cohorts)	0 participants	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: From start of study treatment until 3 weeks after last dose of study treatment, assessed over about 10 weeks.

Population: The expansion schedule chosen was schedule 3. There were a total of 7 patients treated on schedule 3. No dose limiting toxicities (DLT's) were observed in schedule 3 patients.

Dose Limiting toxicities on the arm selected based on the dose/schedule selection part of the study.

Outcome measures

Outcome measures
Measure	Phase 1: Schedule #1 At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 1 infusion of Pembrolizumab in week #7. No interventions within weeks #3 and 4. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 1: Schedule #2 At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 2 infusions of Pembrolizumab; the first given within weeks #3 - 4 and the second in week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 1: Schedule #3 n=3 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 2: Schedule #3 n=4 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab
Dose Limiting Toxicities on the Selected Arm in the Expansion Cohort	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Imaging will be done prior to study treatment, 1 month, 3 months and 6 months after completion of study treatment (about 8.5 months after starting study treatment). Imaging will then be performed according to standard of care.

The percentage of subjects with a response of complete response (CR) or partial response (PR) per immune related response criteria (irRC)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 3 months following last study visit until death

Population: evaluable participants only; all participants are deceased

Time from enrollment until death from any cause

Outcome measures

Outcome measures
Measure	Phase 1: Schedule #1 n=3 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 1 infusion of Pembrolizumab in week #7. No interventions within weeks #3 and 4. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 1: Schedule #2 n=7 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 2 infusions of Pembrolizumab; the first given within weeks #3 - 4 and the second in week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 1: Schedule #3 n=3 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 2: Schedule #3 n=4 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab
Overall Survival	687 days Standard Deviation 224	677 days Standard Deviation 547	547 days Standard Deviation 406	405 days Standard Deviation 339

SECONDARY outcome

Timeframe: Checked from enrollment through first progression, about every 3 months, through death or end of study

Population: Evaluable participants only; all participants are deceased

Time from enrollment to time of first progression after enrollment (days)

Outcome measures

Outcome measures
Measure	Phase 1: Schedule #1 n=3 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 1 infusion of Pembrolizumab in week #7. No interventions within weeks #3 and 4. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 1: Schedule #2 n=7 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 2 infusions of Pembrolizumab; the first given within weeks #3 - 4 and the second in week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 1: Schedule #3 n=3 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 2: Schedule #3 n=4 Participants At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab
Progression-Free Survival	146 days Standard Deviation 52.2	173 days Standard Deviation 218	280 days Standard Deviation 247	152 days Standard Deviation 113

SECONDARY outcome

Timeframe: Blood will be collected about 5 weeks before any treatment, just before first HER2 BATs infusion, before HER2 BATs #5, before HER2 BATs #8, and 2 weeks, 1 month, 3 months, and 6 months after last Pembrolizumab

Sequential monitoring of phenotype, IFN-γ EliSpots, anti-breast cancer cytotoxicity of peripheral blood mononuclear cells (PBMC) directed at breast cancer cell lines, Th1/Th2 serum cytokine patterns, and anti-breast cancer antibodies in the serum during the "vaccinate and consolidate" process

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Imaging will be done prior to study treatment, 1 month, 3 months and 6 months after completion of study treatment. Imaging will then be performed according to standard of care.

The percentage of subjects who achieve complete response, partial response and stable disease following treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Imaging will be done prior to study treatment, 1 month, 3 months and 6 months after completion of study treatment. Imaging will then be performed according to standard of care.

The time from documentation of tumor response to disease progression.

Outcome measures

Outcome data not reported

Adverse Events

Phase 1: Schedule #1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Phase 2: Schedule #2

Serious events: 1 serious events

Other events: 7 other events

Deaths: 7 deaths

Phase 1: Schedule #3

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Phase 2: Schedule #3

Serious events: 2 serious events

Other events: 4 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1: Schedule #1 n=3 participants at risk At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 1 infusion of Pembrolizumab in week #7. No interventions within weeks #3 and 4. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 2: Schedule #2 n=7 participants at risk At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 2 infusions of Pembrolizumab; the first given within weeks #3 - 4 and the second in week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 1: Schedule #3 n=3 participants at risk At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab	Phase 2: Schedule #3 n=4 participants at risk At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. HER2 BATs with Pembrolizumab: 8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab
Gastrointestinal disorders alanine aminotransferase elevation	0.00% 0/3 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	14.3% 1/7 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	0.00% 0/3 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	0.00% 0/4 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.
Vascular disorders Hypotension	33.3% 1/3 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	14.3% 1/7 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	0.00% 0/3 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	25.0% 1/4 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.
Nervous system disorders Confusion	33.3% 1/3 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	0.00% 0/7 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	0.00% 0/3 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	0.00% 0/4 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/3 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	0.00% 0/7 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	0.00% 0/3 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	25.0% 1/4 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.
Cardiac disorders Tachycardia	33.3% 1/3 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	0.00% 0/7 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	0.00% 0/3 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	25.0% 1/4 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.
Vascular disorders Hypertension	0.00% 0/3 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	14.3% 1/7 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	0.00% 0/3 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.	0.00% 0/4 • From enrollment to 30 days after last treatment, up to 3 years Both the related and unrelated SAE's are listed below. SAE's ranged from G1 to G4 below. Some patients experienced more than one toxicity.

Other adverse events

Additional Information

Patrick Dillon, MD

University of Virginia

Phone: 434 924 8073

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place