This is a Phase II trial designed to determine the optimal dose and evaluate the effectiveness of TL938 and trastuzumab in treating patients with HER2+ colorectal cancer that has metastasized or recurred and is inoperable.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Oral administration
Intravenous (IV) infusion
Dose limiting toxicity, maximum tolerated dose, and recommended phase 2 dose
Time frame: Pre-dose up to approximately 24 months post-dose
Objective Response Rate (ORR) by IRC
Time frame: Pre-dose up to approximately 24 months post-dose
Objective Response Rate (ORR) by Investigator
Time frame: Pre-dose up to approximately 24 months post-dose
Duration of Response (DoR)
Time frame: Pre-dose up to approximately 24 months post-dose
Disease Control Rate (DCR)
Time frame: Pre-dose up to approximately 24 months post-dose
Progression Free Survival (PFS)
Time frame: Pre-dose up to approximately 24 months post-dose
Time to Tumor Progression (TTP)
Time frame: Pre-dose up to approximately 24 months post-dose
Time to Treatment Failure (TTF)
Time frame: Pre-dose up to approximately 24 months post-dose
Time to Response (TTR)
Time frame: Pre-dose up to approximately 24 months post-dose
Overall Survival (OS)
Time frame: Pre-dose up to approximately 24 months post-dose
1-year Progression Free Survival
Time frame: Pre-dose up to approximately 24 months post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1-year Survival
Time frame: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Adverse Events (AE)
Time frame: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Adverse Drug Reactions (ADR)
Time frame: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Serious Adverse Events (SAE)
Time frame: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Serious Adverse Reactions (SAR)
Time frame: Pre-dose up to approximately 24 months post-dose
Area Under The Curve (AUC) of TL938
Time frame: Pre-dose up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) of TL938
Time frame: Pre-dose up to 24 hours post-dose
Minimum Plasma Concentration (Cmin) of TL938
Time frame: Pre-dose up to 24 hours post-dose
Time to Peak Drug Concentration (Tmax) of TL938
Time frame: Pre-dose up to 24 hours post-dose
TL938 half-life (T1/2)
Time frame: Pre-dose up to 24 hours post-dose
Volume of Distribution (Vz/F) of TL938
Time frame: Pre-dose up to 24 hours post-dose
Apparent Clearance (CL/f) of TL938
Time frame: Pre-dose up to 24 hours post-dose