Trial Outcomes & Findings for Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Advanced Pancreatic Cancer (NCT NCT01580397)

Last Updated: 2024-06-06

Results Overview

Objective responses were evaluated using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1). Changes (ie, improvements) in tumor measurements from baseline values were assigned a status of CR or PR or SD. Objective response measurements comprised the sum of CR plus PR. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm). Partial Response (PR): \>=30% decrease in the sum of the longest diameter of target lesions, from the baseline sum longest diameter.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Approximately 12 months from enrollment

Results posted on

2024-06-06

Participant Flow

15 subjects were enrolled, whereas 14 subjects participated. 1 subject died prior to treatment start and was not included in analysis.

Participant milestones

Participant milestones
Measure	INNO-206 INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 8 consecutive cycles.
Overall Study STARTED	14
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	INNO-206 INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 8 consecutive cycles.
Overall Study Lack of Efficacy	14

Baseline Characteristics

Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Advanced Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INNO-206 n=15 Participants INNO-206 administered at 350 mg/m\^2 (260 mg/m\^2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 8 consecutive cycles.
Age, Continuous	63.1 years STANDARD_DEVIATION 4.76 • n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	9 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Subjects with Advanced or Unresectable Pancreatic Ductal Carcinoma	15 Participants n=93 Participants

PRIMARY outcome

Timeframe: Approximately 12 months from enrollment

Population: These subjects had more than one cycle of treatment and/or were able to be evaluated for response or disease progression.

Outcome measures

Outcome measures
Measure	INNO-206 n=9 Participants INNO-206 administered at 350 mg/m\^2 (260 mg/m\^2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 8 consecutive cycles. INNO-206: INNO-206 at a total dose of 350 mg/m\^2 (260 mg/m\^2 doxorubicin equivalent) will be administered as a 30 minute IV infusion every 21 days.
Objective Response Rate	0 Participants

SECONDARY outcome

Timeframe: 30 days after last dose, up to 178 days

The primary objective of this study is to determine the preliminary safety of administration of aldoxorubicin in subjects with advanced or unresectable pancreatic ductal adenocarcinoma as measured by the frequency and severity of adverse events (AEs). The following assessments were used to determine if subjects had adverse events: vitals signs (systolic/diastolic blood pressure, pulse, respiration, temperature, weight, and body surface area) physical examination laboratory tests (chemistry, hematology, urinalysis, BSA) additionally, the following scans were performed to determine adverse events: ECHO / MUGA ECG

Outcome measures

Outcome measures
Measure	INNO-206 n=14 Participants INNO-206 administered at 350 mg/m\^2 (260 mg/m\^2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 8 consecutive cycles. INNO-206: INNO-206 at a total dose of 350 mg/m\^2 (260 mg/m\^2 doxorubicin equivalent) will be administered as a 30 minute IV infusion every 21 days.
Number of Participants With Treatment-related Toxicities (Adverse Events)	14 Participants

Adverse Events

INNO-206

Serious events: 11 serious events

Other events: 14 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	INNO-206 n=14 participants at risk INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 8 consecutive cycles.
Blood and lymphatic system disorders Febrile Neutropenia	14.3% 2/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Cardiac disorders Myocardial infarction	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Gastrointestinal disorders Abdominal pain	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Gastrointestinal disorders Mucositis oral	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Gastrointestinal disorders Rectal obstruction	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Gastrointestinal disorders Small intestine obstruction	14.3% 2/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Gastrointestinal disorders Diverticulitis	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
General disorders Fatigue	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Infections and infestations Influenza-Stomach	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Musculoskeletal and connective tissue disorders Back pain	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Psychiatric disorders Suicide attempt	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Renal and urinary disorders Acute renal failure	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Respiratory, thoracic and mediastinal disorders Pneumonia	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Vascular disorders Thromboembolic event	14.3% 2/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.

Other adverse events

Other adverse events
Measure	INNO-206 n=14 participants at risk INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 8 consecutive cycles.
Skin and subcutaneous tissue disorders Alopecia	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Skin and subcutaneous tissue disorders Nail discoloration	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Vascular disorders Hypertension	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Vascular disorders Thromboembolic event	42.9% 6/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Blood and lymphatic system disorders Anemia	28.6% 4/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Blood and lymphatic system disorders Febrile Neutropenia	14.3% 2/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Cardiac disorders Myocardial infarction	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Cardiac disorders Palpitations	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Eye disorders Blurred vision	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Gastrointestinal disorders Abdominal pain	35.7% 5/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Gastrointestinal disorders Constipation	14.3% 2/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Gastrointestinal disorders Diarrhea	14.3% 2/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Gastrointestinal disorders Gastrointestinal disorders, other	14.3% 2/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Gastrointestinal disorders Gastrointestinal pain	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Gastrointestinal disorders Mucositis oral	64.3% 9/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Gastrointestinal disorders Nausea	42.9% 6/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Gastrointestinal disorders Rectal obstruction	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Gastrointestinal disorders Small intestinal obstruction	14.3% 2/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Gastrointestinal disorders Vomiting	21.4% 3/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
General disorders Chills	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
General disorders Fatigue	78.6% 11/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
General disorders Fever	21.4% 3/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
General disorders Gait disturbance	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Infections and infestations Infections and infestations, other	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Infections and infestations Urinary tract infection	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Investigations Blood bilirubin increased	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Investigations Neutrophil count decreased	78.6% 11/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Investigations Platelet count decreased	28.6% 4/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Investigations Weight loss	21.4% 3/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Metabolism and nutrition disorders Anorexia	21.4% 3/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Metabolism and nutrition disorders Dehydration	21.4% 3/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Metabolism and nutrition disorders Hypoalbuminemia	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Metabolism and nutrition disorders Hypocalcemia	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Musculoskeletal and connective tissue disorders Back pain	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Nervous system disorders Ataxia	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Nervous system disorders Concentration impairment	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Nervous system disorders Dizziness	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Nervous system disorders Headache	28.6% 4/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Nervous system disorders Peripheral sensory neuropathy	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Nervous system disorders Stroke	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Psychiatric disorders Anxiety	14.3% 2/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Psychiatric disorders Confusion	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Psychiatric disorders Depression	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Psychiatric disorders Insomnia	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Psychiatric disorders Suicide attempt	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Renal and urinary disorders Renal and urinary disorder- other	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Renal and urinary disorders Urinary frequency	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Respiratory, thoracic and mediastinal disorders Cough	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Respiratory, thoracic and mediastinal disorders Dyspnea	21.4% 3/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	7.1% 1/14 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 178 days. 1 participant signed consent, but did not receive first dose. That subject died.

Additional Information

Sandeep Bobby Reddy, Chief Medical Officer

ImmunityBio

Phone: 855-797-9277

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place