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

NCT07713732 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: TLN-499-2601
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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

Keywords

TLN-499; Venetoclax; Relapsed/Refractory Solid Tumors; Small Cell Lung Cancer; Neuroendocrine Cancer; Malignant Pleural Mesothelioma; Synovial Sarcoma; Phase 1

Outcome Measures

Primary Outcomes (3)

• Incidence of Dose-Limiting Toxicities (DLTs)

  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

  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)

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

  Up to approximately 2 years

Secondary Outcomes (7)

• Maximum Observed Plasma Concentration (Cmax) of TLN-499

  Up to approximately 2 years

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

  Up to approximately 2 years

• Minimum Observed Plasma Concentration (Cmin) of TLN-499

  Up to approximately 2 years

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

  Up to approximately 2 years

• Duration of Response (DOR)

  Up to approximately 2 years

Study Arms (1)

Part 1 Dose Escalation and Part 2 Dose Expansion

EXPERIMENTAL

Drug: TLN-499; Drug: Venetoclax

Interventions

TLN-499 DRUG

Specified dose on specified days

Part 1 Dose Escalation and Part 2 Dose Expansion

Venetoclax DRUG

Specified dose on specified days

Part 1 Dose Escalation and Part 2 Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Treeline Biosciences, Inc.: lead

Study Sites (3)

COBL Clinical Trials - Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Cabrini Hospital Malvern

Malvern, Victoria, 3144, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Neuroendocrine; Mesothelioma, Malignant; Sarcoma, Synovial; Recurrence

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Mesothelioma; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Padma Yerramilli-Rao, MB BS, PhD

  Treeline Biosciences, Inc.

  STUDY CHAIR

Central Study Contacts

Treeline Clinical Operations

CONTACT

857-228-0050; clinicaloperations@treeline.bio

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 20, 2026
• Study Start: July 25, 2026
• Primary Completion (Estimated): August 29, 2030
• Study Completion (Estimated): August 29, 2030
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)