Trial Outcomes & Findings for QUILT-2.017: Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for 1st Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer (NCT NCT00807612)

Last Updated: 2024-09-25

Results Overview

DLTs were defined as grade 3 or higher hematological or nonhematological toxicities that, in the opinion of the investigator, were related to ganitumab or the combination of ganitumab and paclitaxel or carboplatin during this period. These did not include fatigue, nausea, diarrhea, vomiting, hyperglycemia, neutropenia, thrombocytopenia, anemia, lymphopenia, alopecia, increased ALT or AST, or pulmonary embolism unless they met certain criteria.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Part 1 only up to 21 days

Results posted on

2024-09-25

Participant Flow

Primary for discontinuing study 1 subject documented "completed" taken from "end-of-study" page of the CRF site entered ("end of study" defined all subjects that completed 60-day follow-up visit, death, 26 months post final subject randomization, whichever earlier). Based on the date of subject's end-of-study visit, primary reason likely the subject discontinued study to sponsor's early closing of the study. Part 1 and 2 were analyzed together because the same dose was given in both parts.

Participant milestones

Participant milestones
Measure	Ganitumab 18 mg/kg + Paclitaxel/Carboplatin AMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1 AMG 479: AMG 479 at 18mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on Day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 18 mg/kg IV monotherapy for up to 24 months from day 1 Carboplatin: Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6 Paclitaxel: Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
Overall Study STARTED	15
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Ganitumab 18 mg/kg + Paclitaxel/Carboplatin AMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1 AMG 479: AMG 479 at 18mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on Day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 18 mg/kg IV monotherapy for up to 24 months from day 1 Carboplatin: Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6 Paclitaxel: Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
Overall Study Death	8
Overall Study Study early termination	5
Overall Study Withdrawal by Subject	1

Baseline Characteristics

QUILT-2.017: Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for 1st Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ganitumab 18 mg/kg + Paclitaxel/Carboplatin n=15 Participants AMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1 AMG 479: AMG 479 at 18mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on Day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 18 mg/kg IV monotherapy for up to 24 months from day 1 Carboplatin: Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6 Paclitaxel: Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
Age, Continuous	63.8 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Part 1 only up to 21 days

Population: Dose-limiting-toxicity-evaluable subjects were defined as those who had received 1 dose of ganitumab in combination with paclitaxel and carboplatin and had completed 1 cycle (21 days) of study treatment or experienced a DLT related to ganitumab or the combination of ganitumab and paclitaxel/carboplatin during the first cycle (21 days) of study treatment.

Outcome measures

Outcome measures
Measure	AMG 479 18 mg/kg + Paclitaxel/Carboplatin n=6 Participants
Part 1: Number of Dose Limiting Toxicities	0 Participants

PRIMARY outcome

Timeframe: From start of treatment up to approximately 16 months

Part 2: Objective Response Rate as per modified RECIST criteria by investigator review Objective response was defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors \[RECIST\] and was determined only for subjects with measurable disease at baseline. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	AMG 479 18 mg/kg + Paclitaxel/Carboplatin n=15 Participants
Part 2: Objective Response Rate	27 percentage of participants Interval 12.0 to 46.0

SECONDARY outcome

Timeframe: 30 days after last dose, up to 5 months

Adverse events were assessed using CTCAE v 3.0

Outcome measures

Outcome measures
Measure	AMG 479 18 mg/kg + Paclitaxel/Carboplatin n=14 Participants
Number of Participants With Adverse Events	14 Participants

SECONDARY outcome

Timeframe: From start of treatment up to approximately 16 months

Outcome measures

Outcome measures
Measure	AMG 479 18 mg/kg + Paclitaxel/Carboplatin n=15 Participants
Number of Participants With Anti-AMG 479 Antibody Formation Total binding antibody incidence	3 Participants
Number of Participants With Anti-AMG 479 Antibody Formation neutralizing antibody incidence	0 Participants

SECONDARY outcome

Timeframe: From start of treatment up to approximately 16 months

PFS was defined as the time from study day 1 to the first observation of disease progression per investigator review (as classified by modified RECIST or death due to any cause, or censoring. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.

Outcome measures

Outcome measures
Measure	AMG 479 18 mg/kg + Paclitaxel/Carboplatin n=15 Participants
Progression Free Survival	20.0 weeks Interval 14.1 to 23.7

SECONDARY outcome

Timeframe: From start of treatment up to approximately 16 months

Time to Progression (TTP) is defined as the time from Day 1 to the first observation of disease progression (per modified RECIST). Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression. DOR was the time from the first observation of an objective response to the subsequent time of disease progression (per modified RECIST or clinical progression, whichever came first) or death due to any cause. Objective response = a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors \[RECIST\]. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	AMG 479 18 mg/kg + Paclitaxel/Carboplatin n=15 Participants
Time to Progression and Duration of Response Time to Progression	NA Weeks Median and confidence intervals are not available due to insufficient number of subjects with events.
Time to Progression and Duration of Response Duration of Response	NA Weeks Median and confidence intervals are not available due to insufficient number of subjects with events.

Adverse Events

Ganitumab 18 mg/kg + Paclitaxel/Carboplatin

Serious events: 7 serious events

Other events: 14 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Ganitumab 18 mg/kg + Paclitaxel/Carboplatin n=14 participants at risk AMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1 AMG 479: AMG 479 at 18mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on Day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 18 mg/kg IV monotherapy for up to 24 months from day 1 Carboplatin: Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6 Paclitaxel: Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
Infections and infestations Pneumonia	21.4% 3/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Infections and infestations Clostridial Infection	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm Malignant	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Cardiac disorders Tachycardia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
General disorders Asthenia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Investigations Blood Amylase Increased	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Vascular disorders Hypotension	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.

Other adverse events

Other adverse events
Measure	Ganitumab 18 mg/kg + Paclitaxel/Carboplatin n=14 participants at risk AMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1 AMG 479: AMG 479 at 18mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on Day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 18 mg/kg IV monotherapy for up to 24 months from day 1 Carboplatin: Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6 Paclitaxel: Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
Gastrointestinal disorders Nausea	57.1% 8/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Gastrointestinal disorders Diarrhoea	50.0% 7/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Gastrointestinal disorders Vomiting	28.6% 4/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Gastrointestinal disorders Constipation	21.4% 3/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Gastrointestinal disorders Stomatitis	14.3% 2/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Gastrointestinal disorders Abdominal Pain	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Gastrointestinal disorders Abdominal Pain Lower	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Gastrointestinal disorders Abdominal Pain Upper	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Gastrointestinal disorders Haematochezia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
General disorders Fatigue	85.7% 12/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
General disorders Asthenia	21.4% 3/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
General disorders Oedema Peripheral	21.4% 3/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
General disorders Chills	14.3% 2/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
General disorders Pyrexia	14.3% 2/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
General disorders Adverse Drug Reaction	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
General disorders Chest Pain	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
General disorders Infusion Related Reaction	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
General disorders Oedema	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
General disorders Pain	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Metabolism and nutrition disorders Decreased Appetite	64.3% 9/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Metabolism and nutrition disorders Dehydration	21.4% 3/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Metabolism and nutrition disorders Hyperglycaemia	14.3% 2/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Metabolism and nutrition disorders Hyponatraemia	14.3% 2/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Metabolism and nutrition disorders Acidosis	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Metabolism and nutrition disorders Hypercalcaemia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Metabolism and nutrition disorders Hyperuricaemia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Metabolism and nutrition disorders Hypokalaemia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Metabolism and nutrition disorders Hypomagnesaemia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Metabolism and nutrition disorders Hypovolaemia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Nervous system disorders Dysgeusia	42.9% 6/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Nervous system disorders Dizziness	35.7% 5/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Nervous system disorders Peripheral Sensory Neuropathy	35.7% 5/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Nervous system disorders Headache	21.4% 3/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Nervous system disorders Peripheral Motor Neuropathy	21.4% 3/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Nervous system disorders Aphasia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Nervous system disorders Hypoaesthesia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Nervous system disorders Neuropathy Peripheral	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Nervous system disorders Restless Legs Syndrome	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Musculoskeletal and connective tissue disorders Arthralgia	21.4% 3/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Musculoskeletal and connective tissue disorders Muscular Weakness	21.4% 3/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	21.4% 3/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Musculoskeletal and connective tissue disorders Back Pain	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Musculoskeletal and connective tissue disorders Coccydynia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Musculoskeletal and connective tissue disorders Pain In Extremity	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Cough	35.7% 5/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Dyspnoea	21.4% 3/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Haemoptysis	14.3% 2/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Hypoxia	14.3% 2/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Dysphonia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Paranasal Sinus Hypersecretion	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Pneumothorax	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Sinus Congestion	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Wheezing	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Skin and subcutaneous tissue disorders Alopecia	42.9% 6/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Skin and subcutaneous tissue disorders Rash	28.6% 4/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Skin and subcutaneous tissue disorders Dry Skin	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Skin and subcutaneous tissue disorders Pruritus	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Skin and subcutaneous tissue disorders Rash Follicular	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Blood and lymphatic system disorders Anaemia	28.6% 4/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Blood and lymphatic system disorders Neutropenia	28.6% 4/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Blood and lymphatic system disorders Thrombocytopenia	21.4% 3/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Blood and lymphatic system disorders Febrile Neutropenia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Blood and lymphatic system disorders Leukopenia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Infections and infestations Pneumonia	21.4% 3/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Infections and infestations Sinusitis	21.4% 3/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Infections and infestations Lung Infection	14.3% 2/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Infections and infestations Upper Respiratory Tract Infection	14.3% 2/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Infections and infestations Bacteraemia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Infections and infestations Clostridial Infection	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Psychiatric disorders Insomnia	14.3% 2/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Psychiatric disorders Anxiety	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Psychiatric disorders Confusional State	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Psychiatric disorders Depression	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Investigations Alanine Aminotransferase Increased	14.3% 2/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Investigations Aspartate Aminotransferase Increased	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Investigations Blood Amylase Increased	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Investigations Blood Creatinine Increased	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Investigations International Normalised Ratio Increased	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Investigations Weight Decreased	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Vascular disorders Hypertension	14.3% 2/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Vascular disorders Hypotension	14.3% 2/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Vascular disorders Deep Vein Thrombosis	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Vascular disorders Orthostatic Hypotension	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Vascular disorders Superior Vena Caval Occlusion	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Cardiac disorders Supraventricular Tachycardia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Cardiac disorders Tachycardia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Eye disorders Eye Swelling	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Eye disorders Photopsia	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Immune system disorders Hypersensitivity	14.3% 2/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Injury, poisoning and procedural complications Ankle Fracture	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Injury, poisoning and procedural complications Contusion	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Injury, poisoning and procedural complications Excoriation	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm Malignant	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Renal and urinary disorders Pollakiuria	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Renal and urinary disorders Urinary Retention	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Endocrine disorders Hypothyroidism	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.
Reproductive system and breast disorders Galactorrhoea	7.1% 1/14 • 30 days after last dose, up to 5 months Safety analysis population was used for adverse events (only subjects with at least one dose of study drug). Mortality was calculated on all enrolled subjects.

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