Trial Outcomes & Findings for Safety and Clinical Activity of Nivatrotamab in Relapsed/Recurrent Metastatic Small-cell Lung Cancer (NCT NCT04750239)

NCT ID: NCT04750239

Last Updated: 2023-08-14

Results Overview

Summary of DLTs in DLT evaluable subjects.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: Days 1 through 28
• Results posted on: 2023-08-14

Participant Flow

Participant milestones

Measure	Nivatrotamab 50 mcg (Dose Level 1) Subcutaneous administration of nivatrotamab up to 13 cycles Nivatrotamab: Anti GD2×CD3 monoclonal bi-specific antibody
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Nivatrotamab 50 mcg (Dose Level 1) Subcutaneous administration of nivatrotamab up to 13 cycles Nivatrotamab: Anti GD2×CD3 monoclonal bi-specific antibody
Overall Study Withdrawal by Subject	2
Overall Study Trial terminated by sponsor	1

Baseline Characteristics

Safety and Clinical Activity of Nivatrotamab in Relapsed/Recurrent Metastatic Small-cell Lung Cancer

Baseline characteristics by cohort

Measure	Nivatrotamab 50 mcg (Dose Level 1) n=3 Participants Subcutaneous administration of nivatrotamab up to 13 cycles Nivatrotamab: Anti GD2×CD3 monoclonal bi-specific antibody
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	66.0 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 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	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	3 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
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Days 1 through 28

Population: DLT Evaluable Analysis Set

Summary of DLTs in DLT evaluable subjects.

Outcome measures

Measure	Nivatrotamab 50 mcg (Dose Level 1) n=2 Participants Subcutaneous administration of nivatrotamab up to 13 cycles Nivatrotamab: Anti GD2×CD3 monoclonal bi-specific antibody
Dose Limiting Toxicities (DLTs) Phase I	1 participants

PRIMARY outcome

Timeframe: From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days.

Population: Safety analysis set

Number of participants with adverse events as a measure of safety and tolerability.

Outcome measures

Measure	Nivatrotamab 50 mcg (Dose Level 1) n=3 Participants Subcutaneous administration of nivatrotamab up to 13 cycles Nivatrotamab: Anti GD2×CD3 monoclonal bi-specific antibody
Number of Participants With Adverse Events (AEs) for Different Doses of Nivatrotamab in Phase I Any Adverse Event	3 Participants
Number of Participants With Adverse Events (AEs) for Different Doses of Nivatrotamab in Phase I Any Serious Adverse Event	3 Participants

Adverse Events

Nivatrotamab 50 mcg (Dose Level 1)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nivatrotamab 50 mcg (Dose Level 1) n=3 participants at risk Subcutaneous administration of nivatrotamab up to 13 cycles Nivatrotamab: Anti GD2×CD3 monoclonal bi-specific antibody
Immune system disorders Cytokine release syndrome	66.7% 2/3 • Number of events 2 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Vascular disorders Hypotension	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.

Other adverse events

Measure	Nivatrotamab 50 mcg (Dose Level 1) n=3 participants at risk Subcutaneous administration of nivatrotamab up to 13 cycles Nivatrotamab: Anti GD2×CD3 monoclonal bi-specific antibody
Cardiac disorders Atrial fibrillation	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Cardiac disorders Tachycardia	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
General disorders Chills	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
General disorders Injection site reaction	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
General disorders Pyrexia	66.7% 2/3 • Number of events 2 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Infections and infestations Herpes simplex	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Infections and infestations Impetigo	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Infections and infestations Oral candidiasis	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Musculoskeletal and connective tissue disorders Bone pain	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Musculoskeletal and connective tissue disorders Muscular weakness	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Nervous system disorders Somnolence	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Psychiatric disorders Confusional state	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Respiratory, thoracic and mediastinal disorders Pleural effusion	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Skin and subcutaneous tissue disorders Cold sweat	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.
Vascular disorders Orthostatic hypotension	33.3% 1/3 • Number of events 1 • From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days. Non-serious AEs were reported from the day of the first IMP administration until 30 days after the last IMP administration.

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