The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of TLN-499 in combination with venetoclax in participants with relapsed/refractory solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Specified dose on specified days
Specified dose on specified days
COBL Clinical Trials - Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Cabrini Hospital Malvern
Malvern, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Incidence of Dose-Limiting Toxicities (DLTs)
Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-499
Time frame: First 35 days of treatment
Incidence of Adverse Events and Serious Adverse Events
Incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and deaths.
Time frame: Up to approximately 2 years
Overall Response Rate (ORR)
ORR assessed according to RECIST v1.1 (or mRECIST for mesothelioma)
Time frame: Up to approximately 2 years
Maximum Observed Plasma Concentration (Cmax) of TLN-499
Time frame: Up to approximately 2 years
Time to Peak Drug Concentration (Tmax) of TLN-499
Time frame: Up to approximately 2 years
Minimum Observed Plasma Concentration (Cmin) of TLN-499
Time frame: Up to approximately 2 years
Area Under the Plasma Concentration-Time Curve (AUC) of TLN-499
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS)
Time frame: Up to approximately 2 years
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Overall Survival (OS)
Time frame: Up to approximately 2 years