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NCT Number: NCT07713732

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

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.

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Key information

Conditions

Small Cell Lung Cancer ( SCLC ) Adenocarcinoma Adenoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Neuroendocrine Disease Attributes Lung Diseases Lung Neoplasms Malignant Pleural Mesotheliomas (Mpm) Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Cancer Neuroendocrine Tumors Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Neoplasms Recurrence Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Sarcoma, Synovial Small Cell Lung Carcinoma Synovial Sarcomas Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

COBL Clinical Trials - Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TLN-499

Drug

Specified dose on specified days

Venetoclax

Drug

Specified dose on specified days

Primary outcomes

  1. Incidence of Dose-Limiting Toxicities (DLTs)

    Time frame: 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

  2. Incidence of Adverse Events and Serious Adverse Events

    Time frame: Up to approximately 2 years

    Incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and deaths.

  3. Overall Response Rate (ORR)

    Time frame: Up to approximately 2 years

    ORR assessed according to RECIST v1.1 (or mRECIST for mesothelioma)

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of TLN-499

    Time frame: Up to approximately 2 years

  2. Time to Peak Drug Concentration (Tmax) of TLN-499

    Time frame: Up to approximately 2 years

  3. Minimum Observed Plasma Concentration (Cmin) of TLN-499

    Time frame: Up to approximately 2 years

  4. Area Under the Plasma Concentration-Time Curve (AUC) of TLN-499

    Time frame: Up to approximately 2 years

  5. Duration of Response (DOR)

    Time frame: Up to approximately 2 years

  6. Progression-Free Survival (PFS)

    Time frame: Up to approximately 2 years

  7. Overall Survival (OS)

    Time frame: Up to approximately 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Treeline Clinical Operations

CONTACT

[email protected]

857-228-0050

Sponsors and collaborators

Lead sponsor

Treeline Biosciences, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 20, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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