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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNivatrotamab

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 14, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?7 U.S. locations

Locations may change over time.

Who runs it?Y-mAbs Therapeutics

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Y-mAbs Therapeutics
Interventions being studied: Drug: Nivatrotamab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Disease setting

Metastatic or stage IV→Recurrent or relapsed→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Signed and dated informed consent has been provided prior to any trial-related procedures.
Patient willing and able to comply with the trial protocol
Age ≥18 years at the time of informed consent
Histologically or cytologically proven SCLC. Radiographical relapse/progression after minimum 1 line of platinum-containing chemotherapy with partial response or complete response as the best response (only applicable for phase 2) and not more than 3 prior lines of therapy
Measurable disease according to RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Expected survival \>3 months
Platelet counts ≥100,000 cells/mm3
Hemoglobin ≥9 g/dL
Absolute neutrophil count (ANC) ≥1000 cells/mm3
Adequate liver function defined by aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤3 × upper limit of normal (ULN), and serum bilirubin ≤1.5 × ULN with the following exceptions
In patients with documented liver metastases, AST, ALT, and ALP ≤5 × ULN and serum bilirubin ≤1.5 × ULN
Adequate renal function with serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50 mL/min as calculated using the Cockcroft Gault equation
Serum albumin \>3.0 g/dL
Women of child-bearing potential must agree to appropriate contraception during treatment and for a period of 30 days after the last dose of study drug.

Reasons someone may not be able to joinExclusion criteria

Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks prior to the first planned dosing of the investigational Medicinal Product (IMP) per protocol
Patients receiving any other investigational therapy for their cancer within 3 weeks prior to the first planned dosing of the IMP per protocol
Patients who never received platinum-containing regimen for SCLC (defined as less than 2 cycles of platinum doublet)
Persistent \> grade 1 toxicity from previous treatment with checkpoint inhibitors
Any immunosuppressive concomitant medication (i.e., salazopyrine, methotrexate, steroids etc.)
Inability to wean off steroid, unless tapered to 0 mg/day minimum 10 days prior to the first treatment in case of prior use
Any active, uncontrolled viral, fungal, or bacterial infection
Any medical history within 3 months prior to enrolment with need for anticonvulsant therapy
Patients with diagnosis of autoimmune diseases or immunodeficiencies or documented infection with human immunodeficiency virus (HIV) or hepatitis B or C virus (active)
Previous autologous stem cell transplantation or solid organ transplantation
Active heart disease including myocardial infarction within the last 6 months before first dose. This includes cardiac insufficiency with left ventricular ejection fraction (LVEF) \<50%
Active CNS metastases. Patients with treated central nervous system (CNS) metastases are eligible if they are clinically stable without any new neurological symptoms and if there is no radiological evidence of new or enlarging CNS metastases. CNS-directed treatment (surgery, radiation) must be completed 4 weeks prior to the first IMP administration. Furthermore, patients are excluded if they have: Leptomeningeal carcinomatosis Uncontrolled seizures. Patients with known seizure are eligible if they are stable and have been without seizure 4 weeks prior to the first IMP administration
Patients who experienced severe or recurrent (\>grade 2) immune mediated adverse events (AEs) or infusion related reactions (IRRs), including those that lead to permanent discontinuation while on treatment with immune oncology agents
Prior treatment with anti-GD2 antibody or bispecific antibodies
Patients with Limited Disease (LD), who are candidates for local or regional therapy.
Impending need for palliative radiotherapy or surgery for pathological fractures and/or for medullary compression up to 3 weeks prior to the first planned dosing of the IMP per protocol (palliative radiation for other reasons within 2 weeks)
History of other active malignancy within the past 3 years prior to the first planned dosing of the IMP per protocol (excluding non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, incidental prostate cancer (T1a, Gleason score ≤ 6, prostate specific antigen (PSA) less than 0.5 ng/ml)
Patients with a significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Moffitt Cancer CenterTampa, Florida
Emory UniversityAtlanta, Georgia
Henry Ford HospitalDetroit, Michigan
Washington University School of MedicineSt Louis, Missouri
Fox Chase Cancer CenterPhiladelphia, Pennsylvania
UPMC Hillman Cancer CenterPittsburgh, Pennsylvania
Sarah Cannon Research Institute - Tennessee OncologyNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 14, 2023. Always confirm current availability with the study team.

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