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RecruitingLast updated: 17 July 2026

TreeLine TLN -372: A new drug called TLN-372 when given by itself or in combination with other treatments for people with locally advanced or metastatic solid cancers with KRAS mtuationAn 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

TreeLine TLN -372

Clinical summary

Summary

This study is testing a new experimental treatment called TLN-372 in people with advanced cancers that have a KRAS gene mutation.
 
The trial aims to find out:
  • How safe TLN-372 is and what side effects it may cause.
  • How the body absorbs, processes and removes TLN-372 (called pharmacokinetics).
  • Whether TLN-372 can help control or shrink cancer.
TLN-372 may be given on its own or together with other cancer treatments, including cetuximab or pembrolizumab.
 
This is a Phase 1 trial, so the main focus is to determine the safety of the treatment and identify suitable doses for future studies. Researchers will also monitor how the cancer responds to treatment.

 

Conditions

This trial is treating people with locally advanced or metastatic solid cancers with KRAS mutation

Eligibility

Inclusion

  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

  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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Treeline Biosciences, Inc.

Scientific Title

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

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