Trial Outcomes & Findings for QUILT-3.031: AMG 337 in Subjects With Advanced or Metastatic Clear Cell Sarcoma (NCT NCT03132155)

Last Updated: 2024-05-24

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

1 year

Results posted on

2024-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	AMG 337 Subjects self-administered AMG 337 orally (PO) twice a day (BID, approximately every 12 hours) in a fasted state. Dose level 0: 150 mg BID (300 mg/day total) AMG 337 will be administered in patients with advanced or metastatic clear cell sarcoma
Overall Study STARTED	8
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	AMG 337 Subjects self-administered AMG 337 orally (PO) twice a day (BID, approximately every 12 hours) in a fasted state. Dose level 0: 150 mg BID (300 mg/day total) AMG 337 will be administered in patients with advanced or metastatic clear cell sarcoma
Overall Study Lack of Efficacy	6
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

QUILT-3.031: AMG 337 in Subjects With Advanced or Metastatic Clear Cell Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AMG 337 n=8 Participants AMG 337 was administered in patients with advanced or metastatic clear cell sarcoma AMG 337: 6-{(1R)-1-\[8-fluoro-6-(1-methyl-1H-pyrazol-4-yl)\[1,2,4\]triazolo\[4,3-a\]pyridin-3-yl\]ethyl}-3-(2-methoxyethoxy)-1,6-naphthyridin-5(6H)-one•hydrate (1:1)
Age, Continuous	43.3 years STANDARD_DEVIATION 13.74 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	7 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
SUBJECTS WITH ADVANCED OR METASTATIC CLEAR CELL SARCOMA THAT CONTAINS THE EWSR1-ATF1 GENE FUSION	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	AMG 337 n=8 Participants AMG 337 will be administered in patients with advanced or metastatic clear cell sarcoma AMG 337: 6-{(1R)-1-\[8-fluoro-6-(1-methyl-1H-pyrazol-4-yl)\[1,2,4\]triazolo\[4,3-a\]pyridin-3-yl\]ethyl}-3-(2-methoxyethoxy)-1,6-naphthyridin-5(6H)-one•hydrate (1:1)
Objective Response Rate (ORR) Partial Response	1 Participants
Objective Response Rate (ORR) Stable Disease	1 Participants
Objective Response Rate (ORR) Progressive Disease	5 Participants
Objective Response Rate (ORR) Imaging not available to evaluate	1 Participants

SECONDARY outcome

Timeframe: 1 year

To evaluate the safety of AMG 337 based on grade 3 or 4 non-hematologic toxicity.

Outcome measures

Outcome measures
Measure	AMG 337 n=8 Participants AMG 337 will be administered in patients with advanced or metastatic clear cell sarcoma AMG 337: 6-{(1R)-1-\[8-fluoro-6-(1-methyl-1H-pyrazol-4-yl)\[1,2,4\]triazolo\[4,3-a\]pyridin-3-yl\]ethyl}-3-(2-methoxyethoxy)-1,6-naphthyridin-5(6H)-one•hydrate (1:1)
Incidence of Treatment-Emergent Adverse Events (Safety And Tolerability) Subjects with at Least 1 Grade 3 or 4 non-hematologic toxicity	6 Participants
Incidence of Treatment-Emergent Adverse Events (Safety And Tolerability) Subjects without Grade 3 or 4 non-hematologic toxicity.	2 Participants

Adverse Events

AMG 337

Serious events: 3 serious events

Other events: 8 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	AMG 337 n=8 participants at risk AMG 337 was administered in patients with advanced or metastatic clear cell sarcoma AMG 337: 6-{(1R)-1-\[8-fluoro-6-(1-methyl-1H-pyrazol-4-yl)\[1,2,4\]triazolo\[4,3-a\]pyridin-3-yl\]ethyl}-3-(2-methoxyethoxy)-1,6-naphthyridin-5(6H)-one•hydrate (1:1)
Gastrointestinal disorders Abdominal pain	25.0% 2/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
General disorders Pyrexia	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Infections and infestations Diverticulitis	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.

Other adverse events

Other adverse events
Measure	AMG 337 n=8 participants at risk AMG 337 was administered in patients with advanced or metastatic clear cell sarcoma AMG 337: 6-{(1R)-1-\[8-fluoro-6-(1-methyl-1H-pyrazol-4-yl)\[1,2,4\]triazolo\[4,3-a\]pyridin-3-yl\]ethyl}-3-(2-methoxyethoxy)-1,6-naphthyridin-5(6H)-one•hydrate (1:1)
Skin and subcutaneous tissue disorders Dry skin	75.0% 6/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Skin and subcutaneous tissue disorders Rash	37.5% 3/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Skin and subcutaneous tissue disorders Pruritus	25.0% 2/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Skin and subcutaneous tissue disorders Rash pruritic	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Nervous system disorders Headache	75.0% 6/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Nervous system disorders Dizziness	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Gastrointestinal disorders Nausea	50.0% 4/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Nervous system disorders Abdominal pain	25.0% 2/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Gastrointestinal disorders Vomiting	25.0% 2/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Gastrointestinal disorders Diarrhoea	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Blood and lymphatic system disorders Anaemia	37.5% 3/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
General disorders Oedema	25.0% 2/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
General disorders Disease progression	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
General disorders Facial pain	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
General disorders Fatigue	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
General disorders Influenza like illness	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
General disorders Pyrexia	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
General disorders Xerosis	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Psychiatric disorders Anxiety	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Psychiatric disorders Dissociation	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Psychiatric disorders Nightmare	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Psychiatric disorders Restlessness	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Investigations Aspartate aminotransferase increased	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Investigations Blood alkaline phosphatase increased	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Metabolism and nutrition disorders Hypoalbuminaemia	25.0% 2/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Metabolism and nutrition disorders Hyponatraemia	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Respiratory, thoracic and mediastinal disorders Pneumothorax	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Vascular disorders Flushing	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Vascular disorders Hypotension	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Cardiac disorders Supraventricular extrasystoles	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Eye disorders Photophobia	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Infections and infestations Diverticulitis	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Musculoskeletal and connective tissue disorders Muscle spasms	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.
Reproductive system and breast disorders Vaginal discharge	12.5% 1/8 • Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 13 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 13 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up. All-cause mortality approximately 3 years.

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