TLN-499 in Combination With Venetoclax in Patients With Relapsed/Refractory Solid Tumors | NCT07713732

NCT07713732

Overview

NCT ID: NCT07713732
Lead Sponsor: Treeline Biosciences, Inc.INDUSTRY
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
Brief Summary: 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: Small Cell Lung Cancer ( SCLC )
Neuroendocrine Cancer
Malignant Pleural Mesotheliomas (Mpm)
Synovial Sarcomas
Interventions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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

Central Contacts: Treeline Clinical OperationsContact
clinicaloperations@treeline.bio

Locations

COBL Clinical Trials - Chris O'Brien Lifehouse

Camperdown, New South Wales 2050, Australia

Steven KaoContact

Steven.kao@lh.org.au+61 (2) 8514 0594

Steven KaoPrincipal Investigator

Cabrini Hospital Malvern

Malvern, Victoria 3144, Australia

Linear Clinical Research

Nedlands, Western Australia 6009, Australia