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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Single Agent
  • Drug: TLN-372
    Specified dose on specified days
Experimental
Combination Treatment
  • Drug: TLN-372 in combination with cetuximab
    Specified dose on specified days
  • Drug: TLN-372 in combination with pembrolizumab
    Specified dose on specified days

Recruiting Locations

Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215-5450
Contact:
Kailene Sullivan
6176323482
dfcicctiexternalreferral@DFCI.HARVARD.EDU

START Midwest
Grand Rapids 4994358, Michigan 5001836 49546
Contact:
Principal Investigator
616-954-5554
Angela.galindo@startresearch.com

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10021-3402
Contact:
Jamie Walters
917-843-7966

Sarah Cannon Research Institute
Nashville 4644585, Tennessee 4662168 37203
Contact:
Brittany Callaway
615-329-7283
Brittany.Callaway@scri.com

More Details

Status
Recruiting
Sponsor
Treeline Biosciences, Inc.

Study Contact

Treeline Clinical Operations
857-228-0050
clinicaloperations@treeline.bio

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.