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.
Adults ≥18 years of age
Histologically confirmed relapsed/refractory SCLC, neuroendocrine cancer, malignant pleural mesothelioma, or synovial sarcoma
Measurable disease per RECIST v1.1 or mRECIST
ECOG performance status 0-1
Active brain metastases
Major surgery or severe trauma within 4 weeks before first dose
Significant uncontrolled medical conditions preventing study participation
Use of prohibited concomitant medications
Single group
TLN-499
DrugSpecified dose on specified days
Venetoclax
DrugSpecified dose on specified days
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
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.
Overall Response Rate (ORR)
ORR assessed according to RECIST v1.1 (or mRECIST for mesothelioma)
Maximum Observed Plasma Concentration (Cmax) of TLN-499
Time to Peak Drug Concentration (Tmax) of TLN-499
Minimum Observed Plasma Concentration (Cmin) of TLN-499
Area Under the Plasma Concentration-Time Curve (AUC) of TLN-499
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