NCT04750239

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

Terminated Phase 1, PHASE2 Results posted Last updated 14 August 2023

What this trial tests

Phase 1, PHASE2 trial testing Nivatrotamab in SCLC in 3 participants. Terminated before completion.

Timeline

17 August 2021

Primary endpoint
8 April 2022

8 April 2022

Quick facts

Lead sponsor	Y-mAbs Therapeutics
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	17 August 2021
Primary completion	8 April 2022
Estimated completion	8 April 2022
Sites	7 locations across United States

Drugs / interventions tested

• Nivatrotamab — full drug profile →

Conditions studied

• SCLC — all drugs for SCLC →

Sponsor

Y-mAbs Therapeutics — full company profile →

Who can join

18 and older, any sex, with SCLC. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Dose Limiting Toxicities (DLTs) Phase I Primary · Days 1 through 28

Summary of DLTs in DLT evaluable subjects.

Group	Value	95% CI
Nivatrotamab 50 mcg (Dose Level 1)	1

Number of Participants With Adverse Events (AEs) for Different Doses of Nivatrotamab in Phase I Primary · From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days.

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

Any Adverse Event

Group	Value	95% CI
Nivatrotamab 50 mcg (Dose Level 1)	3

Any Serious Adverse Event

Group	Value	95% CI
Nivatrotamab 50 mcg (Dose Level 1)	3

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose until 30 days after last IMP, up to 26 weeks. Actual duration for treated patients were from 21 to 58 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nivatrotamab 50 mcg (Dose Level 1)

Serious: 3/3 (100%)

Deaths: 0/3

Serious adverse events (3 terms)

Reaction	System	Nivatrotamab 50 mcg (Dose …
Cytokine release syndrome	Immune system disorders	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—
Hypotension	Vascular disorders	—

Other adverse events (20 terms — click to expand)

Reaction	System	Nivatrotamab 50 mcg (Dose …
Pyrexia	General disorders	—
Atrial fibrillation	Cardiac disorders	—
Tachycardia	Cardiac disorders	—
Diarrhoea	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Chills	General disorders	—
Injection site reaction	General disorders	—
Herpes simplex	Infections and infestations	—
Impetigo	Infections and infestations	—
Oral candidiasis	Infections and infestations	—
Dehydration	Metabolism and nutrition disorders	—
Bone pain	Musculoskeletal and connective tissue disorders	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—
Somnolence	Nervous system disorders	—
Confusional state	Psychiatric disorders	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—
Cold sweat	Skin and subcutaneous tissue disorders	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—
Orthostatic hypotension	Vascular disorders	—

Most-reported serious reactions: Cytokine release syndrome, Rash maculo-papular, Hypotension.

Data from ClinicalTrials.gov NCT04750239 adverse events section.

Sponsor's own description

Adult patients with small-cell lung cancer (SCLC) will be treated with nivatrotamab a monoclonal anti GD2×CD3 bispecific antibody to investigate the safety and tolerability of the drug.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Glycosylation: mechanisms, biological functions and clinical implications.
   He M, Zhou X, Wang X. · · 2024 · cited 248× · PMID 39098853 · DOI 10.1038/s41392-024-01886-1
2. Targeting Tumor Glycans for Cancer Therapy: Successes, Limitations, and Perspectives.
   Berois N, Pittini A, Osinaga E. · · 2022 · cited 96× · PMID 35158915 · DOI 10.3390/cancers14030645
3. Principles and Current Clinical Landscape of Multispecific Antibodies against Cancer.
   Elshiaty M, Schindler H, Christopoulos P. · · 2021 · cited 71× · PMID 34073188 · DOI 10.3390/ijms22115632
4. Bispecific antibodies in cancer therapy: Target selection and regulatory requirements.
   Sun Y, Yu X, Wang X, Yuan K, et al · · 2023 · cited 62× · PMID 37719370 · DOI 10.1016/j.apsb.2023.05.023
5. Bispecific Antibodies: A Smart Arsenal for Cancer Immunotherapies.
   You G, Won J, Lee Y, Moon D, et al · · 2021 · cited 39× · PMID 34358141 · DOI 10.3390/vaccines9070724
6. Aberrant Glycosylation as Immune Therapeutic Targets for Solid Tumors.
   Matsumoto Y, Ju T. · · 2023 · cited 31× · PMID 37509200 · DOI 10.3390/cancers15143536
7. Anti-glycan monoclonal antibodies: Basic research and clinical applications.
   Gillmann KM, Temme JS, Marglous S, Brown CE, et al · · 2023 · cited 25× · PMID 36905763 · DOI 10.1016/j.cbpa.2023.102281
8. Bispecific Antibodies in Cancer Immunotherapy: A Novel Response to an Old Question.
   Ordóñez-Reyes C, Garcia-Robledo JE, Chamorro DF, Mosquera A, et al · · 2022 · cited 22× · PMID 35745815 · DOI 10.3390/pharmaceutics14061243