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A study to test the safety and effects of TLN-372 alone and with other cancer drugs in patients with advanced solid tumors with KRAS gene changes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying locally advanced or metastatic solid tumors that have a specific change in a gene called KRAS mutant. A gene change, or mutation, is an alteration in the normal genetic instructions that can affect how cells grow and function. The trial will test a medication called TLN-372, which is given as a tablet by mouth. The study will also look at TLN-372 when combined with other cancer treatments, including pembrolizumab (also known as Keytruda), which is given through a vein, and cetuximab (also known as Erbitux), which is also given through a vein. Additionally, itraconazol, an antifungal medication, will be used in the study.

The purpose of the study is to find out if TLN-372 is safe and how well it works against these types of cancers, both when given alone and when combined with other cancer medications. The study will look at what side effects occur, how the body processes the medication, and whether the tumors shrink or stop growing during treatment. The first part of the study will determine the appropriate dose of TLN-372 by carefully monitoring patients for any safety concerns. The second part will examine how effective the medication is at fighting cancer and will test different combinations of treatments.

During the trial, patients will receive TLN-372 either by itself or together with one of the other cancer medications. Doctors will regularly check how patients are responding to treatment through various tests and examinations. The study will monitor for any unwanted effects from the medications and will measure changes in the size of tumors over time. Blood tests will be performed to understand how the medication moves through the body and how long it stays in the system. The trial will continue until enough information is gathered about the safety and effectiveness of these treatment approaches.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
Upon joining the trial, your treatment will begin with TLN-372, which is an investigational medication being tested for advanced solid tumors with a specific genetic change called KRAS mutation.
The medication will be administered either as a tablet that is taken by mouth or in another form, depending on the specific treatment plan assigned to you.
The trial is designed to determine the appropriate dose of TLN-372 and to assess how well it works against your type of cancer.
Step 2
Single agent treatment evaluation
In the first part of the trial, TLN-372 will be given alone without other cancer medications.
The medical team will monitor your response to the treatment and any side effects that may occur.
This phase helps determine the safest and most effective dose of the medication for further testing.
Step 3
Combination treatment phase
In the second part of the trial, TLN-372 may be given in combination with other anti-cancer medications.
One possible combination includes cetuximab, which is given as an intravenous infusion (through a vein). Cetuximab is a medication that targets specific proteins on cancer cells.
Another possible combination includes pembrolizumab, also given as an intravenous infusion. Pembrolizumab is a type of immunotherapy that helps your immune system fight cancer cells.
The specific combination assigned to you will depend on the trial design and your individual medical situation.
Step 4
Supportive medication
Itraconazole may be used during the trial. This medication comes as a 100 mg hard capsule that is taken by mouth.
Itraconazole is an antifungal medication that may be used to manage certain side effects or drug interactions during the treatment.
Step 5
Regular monitoring and assessments
Throughout the trial, regular monitoring will be conducted to assess how the treatment is affecting your cancer and your overall health.
This includes blood tests to check your organ function and detect any abnormalities.
Electrocardiograms (heart rhythm tests) will be performed to monitor your heart function, specifically looking at the QT interval, which measures the time it takes for your heart to reset between beats.
Imaging scans will be performed to measure the size of your tumor and determine if the treatment is working. These assessments follow standardized criteria called RECIST v1.1.
Step 6
Safety evaluations
Your medical team will continuously monitor for any adverse events, which are unwanted or harmful effects that may occur during treatment.
Special attention will be given to dose-limiting toxicities, which are serious side effects that may require adjustment of your medication dose.
If side effects occur, your dose may be temporarily stopped, reduced, or the treatment may be discontinued depending on the severity.
All side effects will be graded according to standardized criteria called NCI CTCAE v5.0, which helps the medical team assess their severity.
Step 7
Treatment response evaluation
The effectiveness of the treatment will be measured by looking at whether your tumor shrinks or stops growing.
If your tumor responds to treatment, the medical team will track how long the response lasts, which is called the duration of response.
This is measured from the time your tumor first shows improvement until it begins to grow again or spread.
Step 8
Pharmacokinetic assessments
Blood samples will be collected at specific times to measure the levels of TLN-372 in your bloodstream.
These tests determine how your body processes the medication, including the maximum concentration reached in your blood, the time it takes to reach that peak, the lowest concentration between doses, and the total exposure to the medication over time.
This information helps determine the optimal dosing schedule for the medication.
Step 9
Ongoing treatment period
Treatment will continue for as long as your cancer responds to the medication and you do not experience unacceptable side effects.
Regular visits will be scheduled to assess your condition and adjust treatment as needed.
The trial is expected to continue until approximately April 2032, though your individual participation may be shorter or longer depending on your response to treatment.

Who can join the trial?

5 criteria

You must be at least 18 years of age or older when you sign the consent form to join the study
You must have locally advanced cancer, which means the cancer has grown beyond where it started but has not spread to distant parts of the body, or metastatic cancer, which means the cancer has spread to other parts of the body
Your cancer must have a specific change in a gene called KRAS mutation, which is an abnormal change in your cancer cells that can be found through testing
You must have a performance status score of 0 or 1 on the ECOG scale, which is a way doctors measure how well you can carry out daily activities. A score of 0 means you are fully active, and a score of 1 means you have some symptoms but can still do light work
Your body organs, such as your liver, kidneys, and bone marrow, must be working well enough, which will be checked through blood tests and other examinations

Who cannot join the trial?

3 criteria

The study does not list specific reasons why patients cannot participate, as the exclusion criteria (reasons that would prevent someone from joining) have not been provided in the available information
If you are interested in this study, the research team will need to check if you meet all requirements during the screening process (initial evaluation to see if you qualify)
General reasons that often prevent participation in cancer studies may include having certain other medical conditions, taking specific medications, or having recently received other cancer treatments, but these specific details are not available for this particular study

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain
Hospital Vall d’Hebron
Verified
Barcelona, Spain

Trial locations

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Investigated drugs

TLN-372
is an investigational medication being tested in this trial. It is designed to target solid tumors that have a specific genetic change called a KRAS mutation. This medication is being studied both on its own and when combined with other cancer treatments to see how well it works against advanced cancer.
Cetuximab
is a cancer medication that works by blocking a protein on the surface of cancer cells that helps them grow. In this trial, it is being tested in combination with TLN-372 to see if the two medications work better together than alone.
Pembrolizumab
is an immunotherapy medication that helps your immune system recognize and fight cancer cells. In this trial, it is being tested in combination with TLN-372 to evaluate the safety of using these two medications together.

What is already known about the treatment

TLN-372
TLN-372 is an experimental medication currently being studied in early-phase clinical trials for the treatment of advanced cancers that have a specific genetic mutation called KRAS. This drug is administered to patients with locally advanced or metastatic solid tumors, meaning cancers that have spread or cannot be surgically removed. The medication works by targeting the KRAS mutation at the molecular level, which is a change in genes that causes cancer cells to grow uncontrollably. TLN-372 is being tested both alone and in combination with other cancer-fighting medications to determine its safety, how the body processes it, and whether it can effectively shrink tumors in patients with KRAS-mutated cancers.
Cetuximab
Cetuximab is an approved cancer medication that is administered through an intravenous infusion directly into the bloodstream. It is widely used in medical practice for treating certain types of colorectal cancer and head and neck cancers. This medication works by blocking a protein called EGFR (epidermal growth factor receptor) on the surface of cancer cells, which prevents the cells from receiving signals that tell them to grow and divide. In this clinical trial, cetuximab is being combined with TLN-372 to evaluate whether the combination can provide better results for patients with KRAS-mutated tumors.
Pembrolizumab
Pembrolizumab is an established immunotherapy medication given as an intravenous infusion that helps the body's immune system fight cancer. It is approved for treating various types of cancers, including melanoma, lung cancer, and many other solid tumors. The medication works by blocking a protein called PD-1 on immune cells, which removes the "brakes" on the immune system and allows it to recognize and attack cancer cells more effectively. In this study, pembrolizumab is being tested in combination with TLN-372 to assess the safety of this combination approach in patients with advanced KRAS-mutated cancers.

Investigated diseases

Locally Advanced or Metastatic Solid Tumors – This condition refers to cancerous growths that have either grown extensively in their original location or have spread to distant parts of the body. Solid tumors are abnormal masses of tissue that do not contain liquid-filled areas or cysts, and can develop in various organs throughout the body. When described as locally advanced, the cancer has grown into nearby tissues or lymph nodes but has not yet spread to distant sites. Metastatic means the cancer cells have traveled through the bloodstream or lymphatic system to form new tumors in other parts of the body. In this study, the focus is specifically on tumors that have a particular genetic change called a KRAS mutation, which affects how cells grow and divide. These tumors continue to grow and spread over time if left unaddressed.