Recruiting
Phase 1

TLN-372

Sponsor:

Treeline Biosciences, Inc.

Code:

NCT07204340

Conditions

KRAS Mutant Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TLN-372

TLN-372 in combination with cetuximab

TLN-372 in combination with pembrolizumab

Study Details

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

Study ID

NCT07204340

Start date

Sep 29, 2025

Status verified date

Jul, 2026

Completion date

Apr 1, 2032

Anticipated

Primary completion date

Dec 3, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

270 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Agent

experimental: Combination Treatment

Interventions

TLN-372

Specified dose on specified days

TLN-372 in combination with cetuximab

Specified dose on specified days

TLN-372 in combination with pembrolizumab

Specified dose on specified days

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Treeline Clinical Operations

857-228-0050clinicaloperations@treeline.bio

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Rebecca Arend

rarend@uabmc.edu

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215-5450

Contacts

Kailene Sullivan

6176323482dfcicctiexternalreferral@DFCI.HARVARD.EDU

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Principal Investigator

616-954-5554Angela.galindo@startresearch.com

Washington University Medical Campus

Recruiting

St Louis, Missouri, United States, 63108

Contacts

Gina Vellequette

314-253-0616g.vellequette@wustl.edu

Memorial Sloan Kettering Cancer Center

Recruiting

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

Contacts

Jamie Walters

917-843-7966

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Brittany Callaway

615-329-7283Brittany.Callaway@scri.com

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 1X6

More Information

Sponsor

Treeline Biosciences, Inc.

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • KRAS mutant solid tumors
  • KRAS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Treeline Biosciences, Inc. on 2026-07-28.