TLN-372
DrugSpecified dose on specified days
Recruiting
NCT Number: NCT07204340
TLN-372 in Advanced KRAS Mutant Solid Tumors
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
Recruiting
Interested in participating?
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients must have measurable disease at study entry.
- Patients must have locally advanced or metastatic KRAS mutant solid tumors.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
Exclusion criteria
- Patients must not have active brain metastases.
- Patients must not have current or past history of central nervous system (CNS) involvement.
- Patients must not have major surgery or severe trauma within 4 weeks prior to the start of the study.
- 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.
- Patients must not have clinically significant cardiovascular disease.
- Pregnant or lactating.
- Conditions that could affect drug absorption.
Treatment and study plan
TLN-372 in combination with cetuximab
DrugSpecified dose on specified days
TLN-372 in combination with pembrolizumab
DrugSpecified dose on specified days
Primary outcomes
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Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372
Time frame: Up to 2 years
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Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) leading to dose modification and discontinuation.
Time frame: Up to 2 years
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Anti-tumor activity of TLN-372 by evaluating the objective response rate (ORR) according to the RESIST v1.1
Time frame: Up to 2 years
Secondary outcomes
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Maximum observed plasma concentration (Cmax) of TLN-372
Time frame: Up to 2 years
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Time to peak drug concentration (Tmax) of TLN-372
Time frame: Up to 2 years
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Minimum observed plasma concentration (Cmin) of TLN-372
Time frame: Up to 2 years
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Area Under the Plasma Concentration-Time Curve (AUC) of TLN-372
Time frame: Up to 2 years
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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
Time frame: Up to 2 years
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Frequency of dose interruptions, reductions and dose intensity
Time frame: Up to 2 years
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Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
Time frame: Up to 2 years
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Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
Time frame: Up to 2 years
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Treeline Biosciences, Inc.
Industry
Registry information
Official study title
An Open-Label, Multicenter, Phase 1 Trial 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
Important dates
- Study start
- 2025
- Primary completion
- 2031
- Study completion
- 2032
- First posted
- Oct 2, 2025
- Registry last updated
- Jul 28, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.