Advance solid tumors harboring the KRAS G12C mutation
Conditions
Brief summary
Dose Escalation: - Safety: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment during the dose escalation part. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory values, electrocardiograms (ECGs), and vital signs by treatment, Dose Escalation: - Tolerability: Frequency of dose interruptions, reductions, and dose intensity, by treatment, Dose Expansion: - ORR per RECIST 1.1 (all groups except the brain metastasis group), Dose Expansion: - OIRR per mRANO-BM (brain metastasis group only), Dose Expansion: - Safety: Incidence and severity of AEs and SAEs, including changes in laboratory values, ECGs, and vital signs, Dose Expansion: - Tolerability: Frequency of dose interruptions, reductions, and dose intensity, Dose Expansion: - Efficacy: ORR* per RECIST 1.1 (JDQ443 dose randomization group only)
Detailed description
Dose Escalation: • ORR, DCR, Best Overall Response (BOR), Progression-free survival (PFS) and Duration of Response (DOR) per RECIST 1.1; and Overall Survival (OS), Dose Escalation: • Plasma or serum concentration vs time profiles and derived PK parameters (i.e. AUC, Cmax, Cmin, Tmax, half-life) of JDQ443 and its metabolite HZC320, TNO155 and tislelizumab., Dose Escalation: • Antidrug antibody (ADA) incidence by treatment, Dose Expansion: - ORR, DCR, BOR, PFS, and DOR per RECIST 1.1; and OS, Dose Expansion: - IDCR, BOIR, IPFS and DOIR per mRANO-BM (brain metastasis group only), Dose Expansion: - Safety: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment. Incidence and severity of AEs and SAEs, including changes in laboratory values, ECGs, and vital signs by treatment, Dose Expansion: - Tolerability: Frequency of dose interruptions, reductions, and dose intensity, by treatment, Dose Expansion: - Plasma or serum concentration vs time profiles and derived PK parameters (i.e. AUC, Cmax, Cmin, Tmax, half-life) of JDQ443 and its metabolite HZC320, TNO155, and tislelizumab, Dose Expansion: - Incidence of anti-tislelizumab antibodies by treatment
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Escalation: - Safety: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment during the dose escalation part. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory values, electrocardiograms (ECGs), and vital signs by treatment, Dose Escalation: - Tolerability: Frequency of dose interruptions, reductions, and dose intensity, by treatment, Dose Expansion: - ORR per RECIST 1.1 (all groups except the brain metastasis group), Dose Expansion: - OIRR per mRANO-BM (brain metastasis group only), Dose Expansion: - Safety: Incidence and severity of AEs and SAEs, including changes in laboratory values, ECGs, and vital signs, Dose Expansion: - Tolerability: Frequency of dose interruptions, reductions, and dose intensity, Dose Expansion: - Efficacy: ORR* per RECIST 1.1 (JDQ443 dose randomization group only) | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose Escalation: • ORR, DCR, Best Overall Response (BOR), Progression-free survival (PFS) and Duration of Response (DOR) per RECIST 1.1; and Overall Survival (OS), Dose Escalation: • Plasma or serum concentration vs time profiles and derived PK parameters (i.e. AUC, Cmax, Cmin, Tmax, half-life) of JDQ443 and its metabolite HZC320, TNO155 and tislelizumab., Dose Escalation: • Antidrug antibody (ADA) incidence by treatment, Dose Expansion: - ORR, DCR, BOR, PFS, and DOR per RECIST 1.1; and OS, Dose Expansion: - IDCR, BOIR, IPFS and DOIR per mRANO-BM (brain metastasis group only), Dose Expansion: - Safety: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment. Incidence and severity of AEs and SAEs, including changes in laboratory values, ECGs, and vital signs by treatment, Dose Expansion: - Tolerability: Frequency of dose interruptions, reductions, and dose intensity, by treatment, Dose Expansion: - Plasma or serum | — |
Countries
Belgium, Denmark, France, Germany, Italy, Netherlands, Spain
Outcome results
None listed