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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Adults ≥18 years of age
2. Histologically confirmed relapsed/refractory SCLC, neuroendocrine cancer, malignant pleural mesothelioma, or synovial sarcoma
3. Measurable disease per RECIST v1.1 or mRECIST
4. ECOG performance status 0-1
5. Adequate hematologic, hepatic, renal, and coagulation function.
6. Life expectancy ≥12 weeks
7. Signed informed consent
Exclusion Criteria:
1. Active brain metastases
2. Major surgery or severe trauma within 4 weeks before first dose
3. Significant uncontrolled medical conditions preventing study participation
4. Use of prohibited concomitant medications
5. Previous conditions that would interfere with study assessments or safety
Primary outcome measure(s)
Incidence of Dose-Limiting Toxicities (DLTs) — First 35 days of treatment 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 — Up to approximately 2 years Incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and deaths.
Overall Response Rate (ORR) — Up to approximately 2 years ORR assessed according to RECIST v1.1 (or mRECIST for mesothelioma)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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