Clinical trial · Interventional
TLN-499 in Combination With Venetoclax in Patients With Relapsed/Refractory Solid Tumors
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
NCT07713732CI-TRIAL-00119530not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Mesotheliomas (Mpm) | Malignant Mesothelioma | PROBABILISTIC | 0.70 |
| Neuroendocrine Cancer | Neuroendocrine Carcinoma | ALIAS | 0.90 |
| Small Cell Lung Cancer ( SCLC ) | Lung Small Cell Carcinoma | ALIAS | 0.85 |
| Synovial Sarcomas | Synovial Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TLN-499 | Drug | — | UNRESOLVED |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Part 1 Dose Escalation and Part 2 Dose Expansion
- interventionNames
- Drug: TLN-499
- Drug: Venetoclax
Primary outcomes (3)
- measure
- Incidence of Dose-Limiting Toxicities (DLTs)
- timeFrame
- First 35 days of treatment
- description
- Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-499
- measure
- Incidence of Adverse Events and Serious Adverse Events
- timeFrame
- Up to approximately 2 years
- description
- Incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and deaths.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.