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RecruitingLast updated: 6 August 2026

TLN-372-2502: Evaluating whether TLN-372 can be taken safely with cobicistat and whether it may help treat people with advanced or metastatic solid cancers with a KRAS mutationAn Open-Label, Multicenter, Phase 1 Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of TLN-372 Co-Administered with a CYP3A Inhibitor in Patients with Advanced KRAS Mutant Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

TLN-372-2502

Clinical summary

Summary

This study is testing a medicine called TLN-372 when taken together with cobicistat.

The study aims to:

  • find out whether TLN-372 is safe when taken with cobicistat
  • understand how the body absorbs, processes, and removes TLN-372 when it is given with cobicistat
  • learn wheather TLN-372 may help treat cancers with a KRAS gene mutation that have spread or cannot be removed with surgery

Who can take part?
You may be able to join this study if you:

  • are aged 18 years or old
  • have a locally advanced or metastatic solid tumour
  • your cancer has a KRAS mutation
  • are well enough to carry out normal daily activities (ECOG performance status 0 or 1)
  • have adequate organ function

What does participation involve?
If you join this study, you will receive TLN-372 and cobicistat.

During the study, you will be monitored with regular clinic visits, blood tests and medical imaging scans.

Researchers hope this study will show whether TLN-372 can be safely used with cobicistat and whether this combination may help treat cancers with a KRAS mutation. The results may help support the future development of new treatment options for people with KRAS-mutant cancers.

Conditions

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

Eligibility

Inclusion

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.

Exclusion

Active brain metastases.

Current or past history of central nervous system (CNS) involvement. Major surgery or severe trauma within 4 weeks prior to the start of the study.

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.

Clinically significant cardiovascular disease. Pregnant or lactating.

Known or suspected hypersensitivity to TLN-372 or cobicistat, or their excipients.

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.
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 ANZCTR *. 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 Co-Administered with a CYP3A Inhibitor in Patients with Advanced KRAS Mutant Solid Tumors

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