TLN-372 in Advanced KRAS Mutant Solid Tumors

NCT07204340 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: TLN-372-2501
• Study Type: interventional
• Target: 240
• Locations: 4 countries
• Sites: 11

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

Conditions

KRAS Mutant Solid Tumors

Keywords

KRAS mutant solid tumors; KRAS

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Study Arms (2)

Single Agent

EXPERIMENTAL

Drug: TLN-372

Combination Treatment

EXPERIMENTAL

Drug: TLN-372 in combination with cetuximab; Drug: TLN-372 in combination with pembrolizumab

Interventions

TLN-372 in combination with pembrolizumab DRUG

Specified dose on specified days

Combination Treatment

TLN-372 DRUG

Specified dose on specified days

Single Agent

TLN-372 in combination with cetuximab DRUG

Specified dose on specified days

Combination Treatment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Treeline Biosciences, Inc.: lead

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215-5450, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

Washington University Medical Campus

St Louis, Missouri, 63108, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10021-3402, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

RECRUITING

Linear Clinical Research

Perth, Western Australia, 6009, Australia

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1X6, Canada

RECRUITING

Hospital Universitary Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

Madrid, 28050, Spain

RECRUITING

MeSH Terms

Interventions

Cetuximab; pembrolizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Treeline Clinical Operations

CONTACT

857-228-0050; clinicaloperations@treeline.bio

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): December 3, 2031
• Study Completion (Estimated): April 1, 2032
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); CA (1); US (6); ES (2)