Solid Tumours
Conditions
Brief summary
Dose escalation: The incidence of dose-limiting toxicities (DLTs) during the DLT period, Dose escalation: Incidence and severity of treatment emergent adverse events (TEAEs), Dose escalation: Incidence and severity of adverse events of special interest (AESIs), Dose escalation: Incidence and severity of serious adverse events (SAEs), Dose escalation: Incidence and severity of grade ≥3 laboratory abnormalities, Dose expansion: Objective Response Rate (ORR)
Detailed description
Dose escalation and dose expansion: Concentrations of REGN7075 in serum, Dose escalation: ORR, Dose escalation and dose expansion: Progression free survival (PFS), Dose escalation and dose expansion: Duration of Response (DOR), Dose escalation and dose expansion: Disease control rate (DCR), Dose escalation and dose expansion: Complete response (CR) rate, Dose escalation and dose expansion: Overall survival (OS), Dose escalation and dose expansion: Incidence of anti-drug antibodies (ADA) to REGN7075, Dose escalation and dose expansion: Titers of ADA to REGN7075, Dose escalation and dose expansion: Incidence of ADA to cemiplimab, Dose escalation and dose expansion: Titers of ADA to cemiplimab, Dose expansion: The incidence and severity of TEAEs, Dose expansion: The incidence and severity of AESIs, Dose expansion: The incidence and severity of SAEs, Dose expansion: The incidence and severity of grade ≥3 laboratory abnormalities, Dose expansion: Patient reported QoL, symptoms, functioning and general health status (per EORTC QLQ-C30, EORTC QLQ-CR29 in CRC patients, EORTC QLQ-BR23 in breast cancer patients, EORTC QLQ-LC13 in NSCLC patients, EORTC QLQ-HN35 in HNSCC patients, and EQ-5D-5L).
Interventions
DRUGLIBTAYO 350 mg concentrate for solution for infusion.
DRUGREGN7075
DRUG1 mg/ml
DRUGAvastin 25 mg/ml concentrate for solution for infusion.
Sponsors
Regeneron Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose escalation: The incidence of dose-limiting toxicities (DLTs) during the DLT period, Dose escalation: Incidence and severity of treatment emergent adverse events (TEAEs), Dose escalation: Incidence and severity of adverse events of special interest (AESIs), Dose escalation: Incidence and severity of serious adverse events (SAEs), Dose escalation: Incidence and severity of grade ≥3 laboratory abnormalities, Dose expansion: Objective Response Rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose escalation and dose expansion: Concentrations of REGN7075 in serum, Dose escalation: ORR, Dose escalation and dose expansion: Progression free survival (PFS), Dose escalation and dose expansion: Duration of Response (DOR), Dose escalation and dose expansion: Disease control rate (DCR), Dose escalation and dose expansion: Complete response (CR) rate, Dose escalation and dose expansion: Overall survival (OS), Dose escalation and dose expansion: Incidence of anti-drug antibodies (ADA) to REGN7075, Dose escalation and dose expansion: Titers of ADA to REGN7075, Dose escalation and dose expansion: Incidence of ADA to cemiplimab, Dose escalation and dose expansion: Titers of ADA to cemiplimab, Dose expansion: The incidence and severity of TEAEs, Dose expansion: The incidence and severity of AESIs, Dose expansion: The incidence and severity of SAEs, Dose expansion: The incidence and severity of grade ≥3 laboratory abnormalities, Dose expansion: Patient reported QoL, symptoms, functioning | — |
Countries
France, Netherlands, Poland, Spain
Outcome results
None listed