TLN-372 in Advanced KRAS Mutant Solid Tumors

Not Applicable

Recruiting

• Conditions: KRAS Mutant Solid Tumors
• Interventions: Drug: TLN-372; Drug: TLN-372 in combination with cetuximab; Drug: TLN-372 in combination with pembrolizumab

• Registration Number: NCT07204340
• Lead Sponsor: Treeline Biosciences, Inc.

Brief Summary

The primary purpose of this study is to evaluate the safety, pharmacokinetics, and anti-tumor activity of TLN-372 as a single agent and in combination with other anti-tumor agents, in patients with advanced KRAS mutant solid tumors

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-24
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Study Start: 2025-10-09
• Primary Completion: 2031-12-03
• Study Completion: 2032-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Patients must have measurable disease at study entry.
2. Patients must have locally advanced or metastatic KRAS mutant solid tumors.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Adequate organ function.

Exclusion Criteria

1. Patients must not have active brain metastases.
2. Patients must not have current or past history of central nervous system (CNS) involvement.
3. Patients must not have major surgery or severe trauma within 4 weeks prior to the start of the study.
4. Patients must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places patients at unacceptable risk of participating in this study.
5. Patients must not have clinically significant cardiovascular disease.
6. Pregnant or lactating.
7. Conditions that could affect drug absorption.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single Agent	TLN-372	-
Combination Treatment	TLN-372 in combination with cetuximab	-
Combination Treatment	TLN-372 in combination with pembrolizumab	-

Primary Outcome Measures

Name	Time	Method
Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372	Up to 2 years
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) leading to dose modification and discontinuation.	Up to 2 years
Anti-tumor activity of TLN-372 by evaluating the objective response rate (ORR) according to the RESIST v1.1	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax) of TLN-372	Up to 2 years
Time to peak drug concentration (Tmax) of TLN-372	Up to 2 years
Minimum observed plasma concentration (Cmin) of TLN-372	Up to 2 years
Area Under the Plasma Concentration-Time Curve (AUC) of TLN-372	Up to 2 years
Anti-tumor activity of TLN-372 by evaluating the duration of response (DOR) as assessed by the time from the date of first objective response to the date of disease progression	Up to 2 years
Frequency of dose interruptions, reductions and dose intensity	Up to 2 years
Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0	Up to 2 years
Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0	Up to 2 years

Trial Locations

Locations (3)

START Midwest; 🇺🇸 Grand Rapids, Michigan, United States

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

Linear Clinical Research; 🇦🇺 Perth, Western Australia, Australia