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Phase 1/2 Study of Oral TRI-611 in Adults With Advanced ALK‑Positive Non‑Small Cell Lung Cancer

Verified siteInvestigationalNo placebo

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What is this trial about?

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

The study focuses on an advanced form of lung cancer called ALK-positive NSCLC, which means the cancer cells have a specific change that helps them grow. The investigational medicine being tested is an oral tablet known as TRI-611, taken by mouth in pill form.

The main goal is to determine whether the medicine is safe and can effectively fight the cancer. Participants will start with low amounts of the tablet and gradually receive higher amounts in a step‑wise manner (dose escalation) to find the most suitable dose. Throughout the study, regular visits will include simple checks such as blood work, heart rhythm recordings, and imaging scans to see how the tumor responds.

During the trial, participants will have their vital signs, laboratory results, and any side effects carefully recorded. Imaging studies will be performed at set intervals to measure changes in tumor size, which helps assess the drug’s ability to shrink or control the cancer (antitumor activity). All procedures are designed to monitor safety and determine the optimal dose for future research.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and baseline assessments
After you agree to join the study, you will complete a series of initial tests. these include medical history review, physical examination, laboratory tests, and imaging studies to confirm advanced alk‑positive nsclc.
The results establish a baseline that will be used to compare later findings.
Step 2
Start of <b>tri‑611</b> treatment (dose escalation phase)
You will begin taking tri‑611 tablets by mouth. the exact dose and how often you take the tablet will be determined by the study protocol and may be adjusted during the dose‑escalation period.
The medication is given as a single daily dose unless the protocol specifies a different schedule.
Step 3
Regular safety monitoring visits
Throughout the treatment period you will attend scheduled clinic visits. at each visit the study team will check vital signs, perform electrocardiograms (ecgs), and repeat laboratory tests to monitor safety.
Any side effects you experience will be recorded and evaluated to determine if the dose needs to be changed.
Step 4
Tumor response evaluations
Periodically you will undergo imaging studies (such as ct scans) to assess the size of the tumor. these scans are used to measure the objective response rate and duration of response, which indicate how well the drug is working.
The timing of these scans follows the schedule defined in the study protocol.
Step 5
Dose adjustment or continuation
Based on safety data and tumor response, the study may increase, decrease, or maintain the current dose of tri‑611. this decision is made to find the optimal dose that balances effectiveness with tolerability.
Step 6
End of treatment and final assessment
Treatment will stop if disease progression is observed, if unacceptable side effects occur, or after the predefined treatment duration is completed.
A final set of safety assessments and imaging studies will be performed to document the overall outcome of the study for you.

Who can join the trial?

17 criteria

You are at least 18 years old when you sign the consent form.
You have advanced ALK‑positive non‑small cell lung cancer (NSCLC) that cannot be removed by surgery or has spread, and this was confirmed by a special test that looks for the ALK gene change.
Your overall health level, measured by the ECOG performance status, is 0 or 1 (meaning you are fully active or able to do light work).
You have already received cancer treatment before joining the study.
Your cancer can be measured using standard imaging criteria called RECIST v1.1 (a system doctors use to see if a tumor is getting bigger or smaller).
You can provide a sample of your tumor (a small piece of tissue or a blood sample) for the study’s laboratory testing.
Any side effects from your previous cancer treatments have mostly gone away and are no worse than a mild level (grade ≤ 1), except for hair loss, mild nerve problems, or certain lab results that are allowed.
Your blood, kidney and liver tests are within the required ranges, including:
- White blood cells (neutrophils) ≥ 1.0 × 10⁹/L
- Platelets ≥ 75 × 10⁹/L
- Hemoglobin ≥ 9.0 g/dL (you may receive a blood transfusion if needed)
- Liver enzymes (ALT and AST) ≤ 2.5 times the normal limit (or ≤ 5 times if liver metastases are present)
- Total bilirubin ≤ 1.5 times the normal limit (higher allowed for certain conditions)
- Kidney function (creatinine clearance) ≥ 60 mL/min
- Blood clotting tests (PT/INR, PTT) ≤ 1.5 times the normal limit unless you are on blood thinners with stable results
- You are able to swallow the study medication in pill form.
- You are willing and able to follow the study’s visit schedule and other requirements.
- You agree to give your written informed consent to take part in the trial.

Who cannot join the trial?

15 criteria

Your tumor must not have any extra genetic changes (called driver alterations) that are known to make ALK‑targeted medicines stop working; tests must look for changes in the MET, EGFR, KRAS, and BRAF genes.
You cannot have lung cancer that has changed its type to small‑cell lung cancer, which is a different and more aggressive form.
If you have cancer that has spread to the brain or spinal cord (CNS metastases) and it is causing worsening symptoms or needs increasing doses of steroids, you are excluded. Stable, symptom‑free brain involvement is allowed.
You must not be receiving any other cancer medicines or experimental drugs at the same time.
You need enough time (a “wash‑out period”) after stopping previous cancer treatments before starting the study drug: at least 7 days after an ALK‑targeted pill, at least 28 days after immune‑system medicines (like checkpoint inhibitors), and at least 28 days or five drug half‑lives for all other cancer drugs.
You cannot have had large‑area radiation therapy or radiation to a vital organ (including the whole brain) within 14 days before the first dose. Small, localized radiation that did not involve a vital organ is allowed if it was given at least 7 days earlier.
Active, uncontrolled infections such as tuberculosis, hepatitis B or C, HIV/AIDS with a low CD4 count, or a COVID‑19 infection that requires treatment will exclude you. Stable, treated infections are permitted.
If you have been diagnosed with another primary cancer or received treatment for it within the past 3 years, you are excluded, except for early skin cancers or cancers that have been completely gone for at least 3 years.
Serious heart or blood‑vessel problems that are not under control will exclude you, including severe heart failure, a heart attack or unstable chest pain within 6 months, high blood pressure that stays above 160/100 mmHg despite medication, dangerous heart rhythm problems (such as certain types of block or a prolonged QT interval), a weak heart pumping ability (ejection fraction below 40%), or a stroke within the past 6 months.
You may not be taking any medicines on the prohibited list unless they can be switched to allowed medicines before you receive the first dose of the study drug.
If you have ever had drug‑induced interstitial lung disease (a serious lung inflammation caused by medication) or you currently have active interstitial lung disease that needs steroid treatment, you cannot join.
You must wait at least 28 days after any major surgery (except for placing a vein line for medication) before the first dose.
Women who could become pregnant and have a positive pregnancy test, women who are breastfeeding, men who plan to father a child during the study or for 6 months after the last dose, or anyone who is not willing to use a highly effective birth‑control method from screening until 6 months after the last dose are excluded.
If you are known to be allergic (have hypersensitivity) to the study drug TRI‑611 or any of its ingredients, you cannot participate.
Any other serious illness, medical condition, past surgery (such as stomach bypass or removal), digestive problems, or abnormal lab test that the doctor believes could affect your safety, how the drug is absorbed, spread, broken down, or removed from your body, or the study results will exclude you.

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Verified sites

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

Azienda Ospedaliero Universitaria Parma
Responsive
Parma, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

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Investigated drugs

TRI-611 is an experimental oral medicine that works by attaching to a protein called ALK and helping the body break it down. In this trial, participants with advanced ALK‑positive non‑small cell lung cancer take the tablet to see if it is safe, how well they can tolerate it, and whether it can shrink or stop the growth of their tumors. The study is looking for the best dose to use in future research and to understand how the drug affects the cancer.

What is already known about the treatment

TRI-611 - This oral tablet is taken by mouth and works as an ALK molecular glue degrader, which attaches to the ALK protein in cancer cells and helps the body break it down, lowering the signals that drive tumor growth. The drug is still investigational and is being studied in early‑phase clinical trials, so it is not yet approved for general medical use. It is being tested mainly for patients with advanced ALK‑positive non‑small cell lung cancer. Pharmacologically, it belongs to the class of protein‑targeting degraders that act like ALK inhibitors.

Investigated diseases

Advanced ALK‑positive non‑small cell lung cancer - Advanced ALK‑positive non‑small cell lung cancer is a type of lung cancer that starts in the larger airway cells and carries a genetic change involving the ALK gene. It usually begins as a tumor in the lung and grows larger over time. As the disease advances, cancer cells can spread to nearby lymph nodes, the chest wall, or distant organs such as the brain or bones. The spread often leads to worsening cough, shortness of breath, and fatigue. The cancer may become resistant to the body's normal control mechanisms, allowing it to continue growing. Its course is marked by gradual increase in tumor size and the appearance of new metastatic sites.