TLN-372 in Advanced KRAS Mutant Solid Tumors

NCT ID: NCT07204340

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-29

Study Completion Date

2032-04-01

Brief Summary

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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

Detailed Description

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Conditions

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KRAS Mutant Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Agent

Group Type EXPERIMENTAL

TLN-372

Intervention Type DRUG

Specified dose on specified days

Combination Treatment

Group Type EXPERIMENTAL

TLN-372 in combination with cetuximab

Intervention Type DRUG

Specified dose on specified days

TLN-372 in combination with pembrolizumab

Intervention Type DRUG

Specified dose on specified days

Interventions

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TLN-372

Specified dose on specified days

Intervention Type DRUG

TLN-372 in combination with cetuximab

Specified dose on specified days

Intervention Type DRUG

TLN-372 in combination with pembrolizumab

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Treeline Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

START Midwest

Grand Rapids, Michigan, United States

Site Status RECRUITING

Washington University Medical Campus

St Louis, Missouri, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status RECRUITING

Linear Clinical Research

Perth, Western Australia, Australia

Site Status RECRUITING

Countries

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United States Australia

Central Contacts

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Treeline Clinical Operations

Role: CONTACT

857-228-0050

Facility Contacts

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Kailene Sullivan

Role: primary

6176323482

Principal Investigator

Role: primary

616-954-5554

Gina Vellequette

Role: primary

314-253-0616

Jamie Walters

Role: primary

917-843-7966 ext. waltersj@mskcc

Brittany Callaway

Role: primary

615-329-7283

Principal Investigator

Role: primary

61 3 8559 5000

Principal Investigator

Role: primary

+61 (08) 6382 5100

Other Identifiers

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TLN-372-2501

Identifier Type: -

Identifier Source: org_study_id

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