Trial Outcomes & Findings for 131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases (NCT NCT03275402)

NCT ID: NCT03275402

Last Updated: 2024-02-13

Results Overview

Overall survival rate at 3 years after the first treatment dose of 131I-omburtamab estimated by the Kaplan-Meier method.

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 52 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2024-02-13

Participant Flow

Participant milestones

Measure	131I-omburtamab One treatment cycle of 131I-omburtamab consists of one dosimetry dose (2 mCi ) (for subjects enrolled on Version 1-7 of Protocol 101) and one treatment dose (50 mCi) for up to 2 cycles of length 5 weeks (for subjects enrolled on Version 1-7 of Protocol 101) or 4 weeks (for subject enrolled after Version 7 of Protocol 101). For Japan only, the first cycle consisted of one dosimetry dose (2 mCi ) week 1 one treatment dose (50 mCi) week 2. If eligible a second cycle of 50 mCi 131I-omburtamab was given at week 6. For subjects below 3 and 1 years of age, the treatment dose was reduced by 33% and 50%, respectively. 131I-omburtamab: Murine IgG1 monoclonal antibody radiolabeled with iodine-131
Overall Study STARTED	52
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Measure	131I-omburtamab One treatment cycle of 131I-omburtamab consists of one dosimetry dose (2 mCi ) (for subjects enrolled on Version 1-7 of Protocol 101) and one treatment dose (50 mCi) for up to 2 cycles of length 5 weeks (for subjects enrolled on Version 1-7 of Protocol 101) or 4 weeks (for subject enrolled after Version 7 of Protocol 101). For Japan only, the first cycle consisted of one dosimetry dose (2 mCi ) week 1 one treatment dose (50 mCi) week 2. If eligible a second cycle of 50 mCi 131I-omburtamab was given at week 6. For subjects below 3 and 1 years of age, the treatment dose was reduced by 33% and 50%, respectively. 131I-omburtamab: Murine IgG1 monoclonal antibody radiolabeled with iodine-131
Overall Study Death	17
Overall Study Study terminated by sponsor	21
Overall Study Withdrawal by Subject	1

Baseline Characteristics

131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases

Baseline characteristics by cohort

Measure	131I-omburtamab n=52 Participants One treatment cycle of 131I-omburtamab consists of 1 dose at 50mCi at week 1. For Japan only one treatment cycle of 131I-omburtamab consists of 2 doses: 2mCi at week 1 and 50mCi at week 2. First cycle is initiated right after confirmation of eligibility at week 1. At week 5 (week 6 for Japan) the participant will be evaluated for safety and if eligible, receive a second cycle of 131I-omburtamab. Secondary efficacy endpoints will be evaluated at week 26 and primary efficacy endpoint will be evaluated at week 156. 131I-omburtamab: Murine IgG1 monoclonal antibody radiolabeled with iodine-131
Age, Categorical <=18 years	52 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	4.7 years STANDARD_DEVIATION 2.45 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	9 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	1 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants
Region of Enrollment Japan	3 participants n=5 Participants
Region of Enrollment Denmark	1 participants n=5 Participants
Region of Enrollment Spain	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Full analysis set

Overall survival rate at 3 years after the first treatment dose of 131I-omburtamab estimated by the Kaplan-Meier method.

Outcome measures

Measure

131I-omburtamab n=52 Participants One treatment cycle of 131I-omburtamab consists of 1 dose at 50mCi at week 1. For Japan only one treatment cycle of 131I-omburtamab consists of 2 doses: 2mCi at week 1 and 50mCi at week 2. First cycle is initiated right after confirmation of eligibility at week 1. At week 5 (week 6 for Japan) the participant will be evaluated for safety and if eligible, receive a second cycle of 131I-omburtamab. Secondary efficacy endpoints will be evaluated at week 26 and primary efficacy endpoint will be evaluated at week 156. 131I-omburtamab: Murine IgG1 monoclonal antibody radiolabeled with iodine-131

Overall Survival Rate

0.65 Proportion of participants Interval 0.49 to 0.78

Adverse Events

131I-omburtamab

Serious events: 20 serious events

Other events: 49 other events

Deaths: 17 deaths

Serious adverse events

Measure	131I-omburtamab n=52 participants at risk One treatment cycle of 131I-omburtamab consists of 1 dose at 50mCi at week 1. For Japan only one treatment cycle of 131I-omburtamab consists of 2 doses: 2mCi at week 1 and 50mCi at week 2. First cycle is initiated right after confirmation of eligibility at week 1. At week 5 (week 6 for Japan) the participant will be evaluated for safety and if eligible, receive a second cycle of 131I-omburtamab. Secondary efficacy endpoints will be evaluated at week 26 and primary efficacy endpoint will be evaluated at week 156. 131I-omburtamab: Murine IgG1 monoclonal antibody radiolabeled with iodine-131
Blood and lymphatic system disorders Anaemia	1.9% 1/52 • Number of events 1 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Blood and lymphatic system disorders Febrile neutropenia	1.9% 1/52 • Number of events 1 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Immune system disorders Hypersensitivity	1.9% 1/52 • Number of events 1 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Infections and infestations Device related infection	1.9% 1/52 • Number of events 1 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Infections and infestations Sepsis	1.9% 1/52 • Number of events 1 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Injury, poisoning and procedural complications Meningitis chemical	1.9% 1/52 • Number of events 1 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Investigations Alanine aminotransferase increased	1.9% 1/52 • Number of events 1 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Investigations Lymphocyte count decreased	7.7% 4/52 • Number of events 4 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Investigations Neutrophil count decreased	1.9% 1/52 • Number of events 1 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Investigations Platelet count decreased	15.4% 8/52 • Number of events 9 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	1.9% 1/52 • Number of events 1 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Nervous system disorders Haemorrhage intracranial	7.7% 4/52 • Number of events 4 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Vascular disorders Haematoma	1.9% 1/52 • Number of events 1 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.

Other adverse events

Measure	131I-omburtamab n=52 participants at risk One treatment cycle of 131I-omburtamab consists of 1 dose at 50mCi at week 1. For Japan only one treatment cycle of 131I-omburtamab consists of 2 doses: 2mCi at week 1 and 50mCi at week 2. First cycle is initiated right after confirmation of eligibility at week 1. At week 5 (week 6 for Japan) the participant will be evaluated for safety and if eligible, receive a second cycle of 131I-omburtamab. Secondary efficacy endpoints will be evaluated at week 26 and primary efficacy endpoint will be evaluated at week 156. 131I-omburtamab: Murine IgG1 monoclonal antibody radiolabeled with iodine-131
Blood and lymphatic system disorders Anaemia	28.8% 15/52 • Number of events 22 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Cardiac disorders Tachycardia	7.7% 4/52 • Number of events 10 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Endocrine disorders Hypothyroidism	7.7% 4/52 • Number of events 4 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Gastrointestinal disorders Abdominal pain	7.7% 4/52 • Number of events 4 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Gastrointestinal disorders Constipation	5.8% 3/52 • Number of events 3 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Gastrointestinal disorders Diarrhoea	5.8% 3/52 • Number of events 3 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Gastrointestinal disorders Nausea	36.5% 19/52 • Number of events 21 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Gastrointestinal disorders Vomiting	34.6% 18/52 • Number of events 25 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
General disorders Fatigue	7.7% 4/52 • Number of events 4 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
General disorders Pain	11.5% 6/52 • Number of events 20 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
General disorders Pyrexia	15.4% 8/52 • Number of events 9 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Injury, poisoning and procedural complications Contusion	5.8% 3/52 • Number of events 3 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Investigations Alanine aminotransferase increased	7.7% 4/52 • Number of events 4 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Investigations Aspartate aminotransferase increased	5.8% 3/52 • Number of events 4 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Investigations Lymphocyte count decreased	30.8% 16/52 • Number of events 19 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Investigations Neutrophil count decreased	42.3% 22/52 • Number of events 43 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Investigations Platelet count decreased	42.3% 22/52 • Number of events 26 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Investigations Protein total decreased	5.8% 3/52 • Number of events 3 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Investigations White blood cell count decreased	44.2% 23/52 • Number of events 34 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Metabolism and nutrition disorders Decreased appetite	11.5% 6/52 • Number of events 6 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Metabolism and nutrition disorders Hyponatraemia	5.8% 3/52 • Number of events 3 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Nervous system disorders Headache	23.1% 12/52 • Number of events 20 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Nervous system disorders Neuralgia	9.6% 5/52 • Number of events 10 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Psychiatric disorders Irritability	7.7% 4/52 • Number of events 4 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Respiratory, thoracic and mediastinal disorders Bronchospasm	5.8% 3/52 • Number of events 6 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Respiratory, thoracic and mediastinal disorders Cough	13.5% 7/52 • Number of events 8 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Respiratory, thoracic and mediastinal disorders Nasal congestion	9.6% 5/52 • Number of events 5 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Skin and subcutaneous tissue disorders Rash	5.8% 3/52 • Number of events 5 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.8% 3/52 • Number of events 3 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Skin and subcutaneous tissue disorders Urticaria	13.5% 7/52 • Number of events 7 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Vascular disorders Haematoma	7.7% 4/52 • Number of events 5 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Vascular disorders Hypertension	7.7% 4/52 • Number of events 8 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.
Vascular disorders Hypotension	7.7% 4/52 • Number of events 9 • Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years. All adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. All SAEs were reported. Note that from 3 weeks after last IMP administration and during the 3-year long term follow-up only SAEs considered related to IMP and new onset for cancers were collected.

Additional Information

Joris Wilms

Y-mAbs Therapeutics

Phone: +4570261414

Email: clinicaltrials@ymabs.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place