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IMCnyeso in advanced solid tumors
NCT03515551Phase 2
Key facts
- Status
- Terminated
- Start
- Jun 2018
- Primary completion
- May 2021
- Countries
- 3
- Sponsor
- Immunocore
- Modality
- Bispecific Antibodies, Monoclonal Antibodies, Fc-Fusion Proteins
- Drugs
- IMCnyeso
- Conditions
- solid tumor (advanced stage)
01
Overview
Phase 2, open-label trial of IMCnyeso in solid tumor (advanced stage) (2 arms), sponsored by Immunocore. Primary endpoints: Number of Participants With Dose-limiting Toxicities up to 35 months, Number of Participants With Adverse Events up to 35 months and 2 more. Started Jun 2018; status: terminated.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Phase 1: Dose Escalation
Dose escalation cohorts to determine MTD/RP2D of IMCnyeso
Phase 2: Dose Expansion
Dose expansion cohorts at RP2D (Not initiated)
03
Who it enrols
Adult patients with HLA-A*0201 positive and NY-ESO-1/LAGE-1A positive advanced solid tumors who have relapsed from or are intolerant to standard therapy.
04
Endpoints
Primary
Number of Participants With Dose-limiting Toxicities
Number of Participants With Adverse Events
Number of Participants With No Dose Interruptions or Reductions
Best Overall Response
Secondary
Progression-free Survival
Duration of Response
Overall Survival
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Measurable Concentration
Maximum Observed Plasma Drug Concentration
Time to Reach Maximum Plasma Concentration
Number of Participants With Anti-IMCnyeso Antibody Formation
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