TLN-372 for KRAS-mutant advanced or metastatic solid tumors

Inclusion criteria

• {"criterion_text":"- 1. At least 18 years of age at the time of signing the informed consent form (ICF)."}
• {"criterion_text":"- 2. Patients must have locally advanced or metastatic KRAS mutant solid tumors"}
• {"criterion_text":"- 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1"}
• {"criterion_text":"- 4. Adequate organ function"}

Exclusion criteria

• {"criterion_text":"- 1. Patients must not have active brain metastases"}
• {"criterion_text":"- 2. Patients must not have current or past history of central nervous system (CNS) disease"}
• {"criterion_text":"- 3.\tPatients must not have major surgery or severe trauma within 4 weeks prior to the first dose of the study drug"}
• {"criterion_text":"- 4.\tPatients 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"}
• {"criterion_text":"- 5.\tPatients must not have clinically significant cardiovascular disease."}
• {"criterion_text":"- 6.\tPregnant or lactating"}
• {"criterion_text":"- 7.\tConditions that could affect drug absorption"}

Primary endpoints

• {"endpoint_text":"- Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372","definition_or_measurement_approach":"Per protocol-defined dose-limiting toxicity (DLT) criteria; count of patients experiencing AEs that meet protocol DLT criteria after TLN-372 administration."}
• {"endpoint_text":"- Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) leading to dose modification and discontinuation.","definition_or_measurement_approach":"Assessment of incidence and severity of TEAEs and TRAEs, including those that lead to dose modification or discontinuation (as reported in safety assessments)."}
• {"endpoint_text":"- Anti-tumor activity of TLN-372 by evaluating the objective response rate (ORR) according to the RESIST v1.1","definition_or_measurement_approach":"Objective response rate (ORR) assessed according to RECIST v1.1 criteria."}

Secondary endpoints

• {"endpoint_text":"- Maximum observed plasma concentration (Cmax), time to peak drug concentration (Tmax), Minimum observed plasma concentration (Cmin), and Area Under the Plasma Concentration-Time Curve (AUC) of TLN-372","definition_or_measurement_approach":"Pharmacokinetic measures: Cmax, Tmax, Cmin, and AUC derived from plasma concentration-time data for TLN-372."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Duration of response (DOR) measured from date of first documented objective response to date of disease progression."}
• {"endpoint_text":"- Frequency of dose interruptions, reductions and dose intensity","definition_or_measurement_approach":"Recording frequency and instances of dose interruptions, dose reductions and calculation of dose intensity."}
• {"endpoint_text":"- Clinically significant ECG QT interval from baseline assessed as per NCI CTCAE v5.0","definition_or_measurement_approach":"Assessment of clinically significant changes in ECG QT interval from baseline per NCI CTCAE v5.0."}
• {"endpoint_text":"- Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0","definition_or_measurement_approach":"Assessment of clinically significant laboratory abnormalities from baseline in safety labs using NCI CTCAE v5.0 criteria."}

Spain

Earliest CTIS Part Ii Submission Date

06-11-2025

Latest Decision Or Authorization Date

07-01-2026

Processing Time Days

62

Number Of Sites

2

Number Of Participants

20

Primary sponsor

Full Name

Treeline Biosciences Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Medidata Solutions Inc.

Responsibilities

Central Imaging portal

Name

Almac Clinical Services LLC

Responsibilities

Clinical supply and other services (codes listed: 14, 3)

Name

Precision for Medicine

Responsibilities

Central lab kitting, specimen storage and shipment; lab and sample handling services

Name

Alturas Analytics Inc.

Responsibilities

PK specimen analysis

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Central Imaging portal; sponsor duties include code 7 (unspecified)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"Sponsor duties include codes 14 and 3 (roles not expanded in available data)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Precision for Medicine","duties_or_roles":"Central lab kitting, specimen storage and shipment; other duties (codes 1,10,12,2,5,6,7,8) listed","organisation_type":"Health care"}
• {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"PK specimen analysis","organisation_type":"Pharmaceutical company"}