Phase 1 Safety and Pharmacokinetics Study in Patients With Relapsed/Refractory Solid Tumors

July 14, 2026 updated by: Treeline Biosciences, Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • COBL Clinical Trials - Christ O'Brien Lifehouse
        • Principal Investigator:
          • Steven Kao
        • Contact:
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Cabrini Hospital Malvern
        • Principal Investigator:
          • Surein Arulananda
        • Contact:
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Linear Clinical Research
        • Contact:
        • Principal Investigator:
          • Timothy Humphries

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 Dose Escalation and Part 2 Dose Expansion
Drug: Venetoclax
Specified dose on specified days
Drug: TLN-499
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
First 35 days of treatment
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.
Up to approximately 2 years
Overall Response Rate (ORR)
Time Frame: Up to approximately 2 years
ORR assessed according to RECIST v1.1 (or mRECIST for mesothelioma)
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of Response (DOR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Progression-Free Survival (PFS)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Overall Survival (OS)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Maximum Observed Plasma Concentration (Cmax) of TLN-499
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Time to Peak Drug Concentration (Tmax) of TLN-499
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Minimum Observed Plasma Concentration (Cmin) of TLN-499
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Area Under the Plasma Concentration-Time Curve (AUC) of TLN-499
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Treeline Biosciences, Inc.

Investigators

  • Study Chair: Padma Yerramilli-Rao, MB BS, PhD, Treeline Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 25, 2026

Primary Completion (Estimated)

August 29, 2030

Study Completion (Estimated)

August 29, 2030

Study Registration Dates

First Submitted

July 9, 2026

First Submitted That Met QC Criteria

July 14, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLN-499-2601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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