Pretreated mismatch-repair-proficient and microsatellite stable metastatic colorectal cancer, and other metastatic GI cancers
Conditions
Brief summary
Safety and tolerability: Incidence of DLTs (Main Study/Dose Escalation only only), Safety and tolerability: Incidence of Treatment Emergent Adverse Events (TEAEs) occurring while patients are on treatment or up to 30 days after the last dose of last study treatment, Safety and tolerability: Incidence of Serious Adverse Events (SAEs) occurring while patients are on treatment or up to 90 days after the last dose of last study treatment or to a minimum of 30 days after the last IMP intake in case of initiation of new anti-cancer therapy, whichever occurs first, Safety and tolerability: Changes in clinical laboratory parameters, vital signs, ECOG performance status, ECG and physical examination, Efficacy: DCR, defined as the proportion of patients who have achieved CR, PR, or stable disease (SD), Efficacy: ORR, defined as the proportion of patients who have achieved CR or PR
Detailed description
Exploratory: PD-L1 expression by CPS (Main Study/Expansion), Exploratory: Change in biomarkers in blood and tumour samples, Exploratory: Change in blood and tumour-infiltrating immune cells, Efficacy: DOR, defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression, Efficacy: PFS, defined as the time from the first dose of study drugs to the earlier date of assessment of progression, or death by any cause in the absence of progression, Efficacy: PFSR, defined as the proportion of patients alive and free of disease progression at specific timepoints, Efficacy: OS, defined as the time from the first dose of study drugs to the date of death by any cause
Interventions
DRUGCR6086
DRUGBalstilimab
Sponsors
Rottapharm Biotech S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability: Incidence of DLTs (Main Study/Dose Escalation only only), Safety and tolerability: Incidence of Treatment Emergent Adverse Events (TEAEs) occurring while patients are on treatment or up to 30 days after the last dose of last study treatment, Safety and tolerability: Incidence of Serious Adverse Events (SAEs) occurring while patients are on treatment or up to 90 days after the last dose of last study treatment or to a minimum of 30 days after the last IMP intake in case of initiation of new anti-cancer therapy, whichever occurs first, Safety and tolerability: Changes in clinical laboratory parameters, vital signs, ECOG performance status, ECG and physical examination, Efficacy: DCR, defined as the proportion of patients who have achieved CR, PR, or stable disease (SD), Efficacy: ORR, defined as the proportion of patients who have achieved CR or PR | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory: PD-L1 expression by CPS (Main Study/Expansion), Exploratory: Change in biomarkers in blood and tumour samples, Exploratory: Change in blood and tumour-infiltrating immune cells, Efficacy: DOR, defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression, Efficacy: PFS, defined as the time from the first dose of study drugs to the earlier date of assessment of progression, or death by any cause in the absence of progression, Efficacy: PFSR, defined as the proportion of patients alive and free of disease progression at specific timepoints, Efficacy: OS, defined as the time from the first dose of study drugs to the date of death by any cause | — |
Countries
Italy
Outcome results
None listed