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TLN-372 in Advanced KRAS Mutant Solid Tumors

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07204340
Enrollment
240
Registered
2025-10-02
Start date
2025-09-29
Completion date
2032-04-01
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

KRAS Mutant Solid Tumors

Keywords

KRAS mutant solid tumors, KRAS

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

Interventions

DRUGTLN-372

Specified dose on specified days

DRUGTLN-372 in combination with cetuximab

Specified dose on specified days

DRUGTLN-372 in combination with pembrolizumab

Specified dose on specified days

Sponsors

Treeline Biosciences, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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 v1.1Up to 2 years
Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372Up to 2 years

Secondary

MeasureTime frame
Area Under the Plasma Concentration-Time Curve (AUC) of TLN-372Up 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 progressionUp to 2 years
Frequency of dose interruptions, reductions and dose intensityUp to 2 years
Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0Up to 2 years
Maximum observed plasma concentration (Cmax) of TLN-372Up to 2 years
Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0Up to 2 years
Time to peak drug concentration (Tmax) of TLN-372Up to 2 years
Minimum observed plasma concentration (Cmin) of TLN-372Up to 2 years

Countries

Australia, Canada, Spain, United States

Contacts

CONTACTTreeline Clinical Operations
clinicaloperations@treeline.bio857-228-0050

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026