TLN-499 plus venetoclax in relapsed or refractory solid tumors
Official title: An Open-Label, Multicenter, Phase 1 Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of TLN-499 in Combination With Venetoclax in Patients With Relapsed/Refractory Solid Tumors
Run by Treeline Biosciences, Inc. · NCT07713732 · Data updated 2026-11-12
Doctors are testing whether TLN-499 added to venetoclax can help patients with relapsed or refractory solid tumors, including SCLC and certain neuroendocrine cancers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Treeline Biosciences, Inc. Industry-sponsored |
| Locations | 3 sites (Camperdown, New South Wales and 2 other locations) |
| Status | Recruiting |
| Started | August 5, 2026 |
| Main results expected | August 29, 2030 |
| Study ends | August 29, 2030 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT07713732 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with relapsed or refractory SCLC, neuroendocrine cancer, malignant pleural mesothelioma, or synovial sarcoma, and adequate organ function.
✕Probably not a fit
Patients whose tumors do not respond, or who discontinue due to toxicity, may not experience benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a first-in-human Phase 1 study to evaluate safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of TLN-499 in combination with venetoclax in adults with relapsed/refractory solid tumors. Eligible tumor types include small cell lung cancer, other neuroendocrine cancers, malignant pleural mesothelioma, and synovial sarcoma. Participants must have measurable disease, good performance status, and adequate organ function, and must not have active brain metastases or other contraindicating conditions. The study is conducted at select clinical research sites in Australia with Treeline Biosciences as lead sponsor.
Why it matters
Potential benefit: If successful, participants may experience tumor shrinkage or slowed progression from the combination therapy.
How similar studies have gone: Similar combination approaches have shown activity in solid tumors, but this is an early Phase 1, first-in-human study with limited prior data for TLN-499.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Linear Clinical Research
Nedlands, Western Australia, Australia Recruiting -
COBL Clinical Trials - Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia Not yet recruiting -
Cabrini Hospital Malvern
Malvern, Victoria, Australia Not yet recruiting
Study contacts
- Study coordinator: Treeline Clinical Operations
- Email: clinicaloperations@treeline.bio
- Phone: 857-228-0050
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.