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

SCLC Clinical Trial

Official title:
Safety and Clinical Activity of Nivatrotamab, an Anti GD2×CD3 Bispecific Antibody, in Relapsed/Recurrent Metastatic Small-cell Lung Cancer An Open-label, Single-arm, Multicenter, Phase 1/2 Trial

Clinical Trial 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.

Clinical Trial Description

The study will include a phase 1 dose escalation part to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D). This will be conducted following a modified Bayesian Optimal Interval Design (mBOIN) design. For the purpose of dose escalation, dose-limiting toxicities (DLTs) will be collected and assessed for a period of 28 days (the DLT evaluation period). A phase 2 dose expansion part will follow the phase 1 dose escalation. In phase 2, patients will be stratified according to whether they have platinum sensitive or platinum-resistant SCLC. Phase 2 will assess the long term safety and tolerability of nivatrotamab as well as the clinical activity of nivatrotamab when administered at the obtained MTD/RP2D in phase 1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04750239
Study type Interventional
Source Y-mAbs Therapeutics
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date August 17, 2021
Completion date April 8, 2022
View Details
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