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Not yet recruiting NCT07713732

TLN-499 in Combination With Venetoclax in Patients With Relapsed/Refractory Solid Tumors

Phase I Interventional Small Cell Lung Cancer ( SCLC ) Neuroendocrine Cancer Malignant Pleural Mesotheliomas (Mpm) Synovial Sarcomas

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TLN-499, Venetoclax.
Who it may be relevant to
Registry conditions: Small Cell Lung Cancer ( SCLC ), Neuroendocrine Cancer, Malignant Pleural Mesotheliomas (Mpm), Synovial Sarcomas. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug TLN-499
    Specified dose on specified days
  • Drug Venetoclax
    Specified dose on specified days

Primary outcome measures

  • Incidence of Dose-Limiting Toxicities (DLTs) [Time frame: First 35 days of treatment]
  • Incidence of Adverse Events and Serious Adverse Events [Time frame: Up to approximately 2 years]
  • Overall Response Rate (ORR) [Time frame: Up to approximately 2 years]
Secondary outcome measures (7)
  • 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]
  • Overall Survival (OS) [Time frame: Up to approximately 2 years]

Eligibility criteria

Inclusion criteria

  • 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
  • Adequate hematologic, hepatic, renal, and coagulation function.
  • Life expectancy ≥12 weeks
  • Signed informed consent

Exclusion criteria

  • 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
  • Previous conditions that would interfere with study assessments or safety

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 3 centers
  • COBL Clinical Trials - Chris O'Brien Lifehouse — Camperdown
  • Cabrini Hospital Malvern — Malvern
  • Linear Clinical Research — Nedlands

Identifiers

NCT: NCT07713732 · TLN-499-2601

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗