Locally advanced or metastatic solid tumors
Conditions
Brief summary
Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372, Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) leading to dose modification and discontinuation., Anti-tumor activity of TLN-372 by evaluating the objective response rate (ORR) according to the RESIST v1.1
Detailed description
Maximum observed plasma concentration (Cmax), time to peak drug concentration (Tmax), Minimum observed plasma concentration (Cmin), and Area Under the Plasma Concentration-Time Curve (AUC) of TLN-372, Anti-tumor activity of TLN-372 by evaluating the duration of response (DOR) as assessed by the time from the date of first objective response to the date of disease progression, Frequency of dose interruptions, reductions and dose intensity, Clinically significant ECG QT interval from baseline assessed as per NCI CTCAE v5.0, Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
Interventions
DRUGItraconazol – 1 A Pharma® 100 mg Hartkapseln
DRUGTLN-372
DRUGErbitux 5 mg/mL solution for infusion
Sponsors
Treeline Biosciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372, Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) leading to dose modification and discontinuation., Anti-tumor activity of TLN-372 by evaluating the objective response rate (ORR) according to the RESIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax), time to peak drug concentration (Tmax), Minimum observed plasma concentration (Cmin), and Area Under the Plasma Concentration-Time Curve (AUC) of TLN-372, Anti-tumor activity of TLN-372 by evaluating the duration of response (DOR) as assessed by the time from the date of first objective response to the date of disease progression, Frequency of dose interruptions, reductions and dose intensity, Clinically significant ECG QT interval from baseline assessed as per NCI CTCAE v5.0, Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0 | — |
Countries
Spain
Outcome results
None listed