A phase 1B/2A study to assess the safety, tolerability, pharmacokinetic and anti-tumoral activity of EXS21546 in combination with a PD-1 inhibitor in patients with advanced solid tumours.
A phase 1B/2A study to assess the safety, tolerability, pharmacokinetic and anti-tumoral activity of EXS21546 in combination with a PD-1 inhibitor, nivolumab, in patients with advanced solid tumours, non small cell lung cancer and renal cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
EXS21546 Granule in Capsule
Institute Jules Bordet
Brussels, Belgium
CHU Mont-Godinne
Namur, Belgium
Institut Bergonie
Bordeaux, France
Centre GF Leclerc
Dijon, France
Centre Eugene Marquis
Rennes, France
Safety of EXS21546 in combination with nivolumab.
Incidence of treatment-emergent adverse events (TEAEs) and SAEs characterised by type, incidence, severity (graded by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0), seriousness, timing and relationship to EXS21546 dosing.
Time frame: Through study completion, an average of 6 months
Dose-limiting toxicities (DLTs) of EXS21546 in combination with nivolumab.
Incidence of dose limiting toxicities (DLTs) during Cycle 1 (initial 28 days) of treatment with escalating doses of EXS21546 in combination with an approved dose of nivolumab.
Time frame: Through dose escalation completion, an average of 6 months
Preliminary anti-tumoural activity of EXS21546 in combination with nivolumab.
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Time frame: Through study completion, an average of 6 months
Treatment adherence of EXS21546 in combination with nivolumab.
Number of doses recorded in the treatment diary.
Time frame: Through study completion, an average of 6 months
Tolerability of EXS21546 in combination with nivolumab.
Frequency of dose interruptions, dose reductions and dose intensity achieved.
Time frame: Through study completion, an average of 6 months
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