A Phase 1/2 interventional study of Sym004 and Nivolumab in Squamous Non-Small Cell Lung Cancer, sponsored by Symphogen A/S. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-28.
Sponsored by Symphogen A/S · Phase 1/2, Interventional, and Treatment
This is a phase 1b/2b study investigating the safety and preliminary antitumor effects of Sym004 in combination with nivolumab versus nivolumab monotherapy when administered every second week.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →Symphogen A/S is the lead sponsor of 16 studies on the registry; none are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Phase 1b, dose-escalation: Dose Level 1: Sym004 + nivolumab (Q2W) Dose Level 2: Sym004 + nivolumab (Q2W) Dose Level -1: Sym004 + nivolumab, if needed
Drug: Sym004 · Drug: Nivolumab
Phase 2b, dose-expansion: Receiving Sym004 in the RP2D in combination with nivolumab (Q2W)
Drug: Sym004 · Drug: Nivolumab
Phase 2b, dose-expansion: Receiving nivolumab monotherapy (Q2W)
Drug: Nivolumab
Sym004 is a 1:1 mixture of two monoclonal antibodies (mAbs) which bind to two non-overlapping epitopes of the Epidermal Growth Factor Receptor (EGFR). Sym004 will be administered at different dose-levels via infusion Q2W
Nivolumab is a humanized immunoglobulin G4 (IgG4) anti-PD-1 monoclonal antibody. Nivolumab will be administered via 60-minute infusion Q2W
Phase 1b: Determination of the Dose-Limiting Toxicities (DLT) and the MTD and/or RP2D of escalating doses of Sym004 in combination with a standard dose of nivolumab
Time frame: 1 year
Phase 2b: Evaluation of the antitumor effects of the RP2D of Sym004 when administered in combination with a standard dose of nivolumab as measured by Response Rate
Time frame: 1.5 years
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Futuximab
Carcinoma, Non-Small-Cell Lung →
Symphogen A/S