Not yet recruiting

A study to evaluate the safety and effectiveness of H-CYS(SS)-GLU-VAL-SER-GLN-LEU-LEU-LYS-GLY-ASP-ALA-CYS(SS)-OH in patients with advanced solid tumors who have completed other treatments.

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This study is being conducted to evaluate the safety and early effectiveness of a new drug called TAX2 in people with certain types of advanced cancers. The research focuses on individuals with Ovarian Cancer, Colorectal Cancer, Pancreatic Cancer, or Melanoma. These conditions are described as relapsed or refractory, which means the cancer has returned after previous treatments or has not responded to the medicines already used. The cancer is also considered metastatic, meaning it has spread from its original location to other parts of the body.

The treatment, TAX2, is administered through an intravenous infusion, which is a method of delivering medicine directly into a vein using a tube. The purpose of the study is to determine how much of this drug can be safely given and how it behaves within the body. During the initial part of the study, different amounts of the medicine are given to patients to find the most appropriate dose. This is followed by a phase where a specific amount is tested in a larger group to continue monitoring safety and how the drug affects the tumor.

Researchers will monitor how the body processes the medicine, known as pharmacokinetics, and how the medicine affects the body's biological functions, known as pharmacodynamics. Scientists will also look for any adverse events, which are side effects or unintended medical problems that may occur during the treatment. The study aims to see if there is any anti-tumour activity, meaning the medicine has the ability to shrink or stop the growth of the cancer cells.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the dose escalation phase
You will receive the study medication, TAX2, which is provided as a solution for injection.
The medication is administered through an intravenous infusion, which means it is delivered directly into a vein.
This phase is designed to evaluate the safety and tolerability of the medication by testing increasing doses to determine how the body reacts.
Step 2
Participation in the safety expansion phase
If the appropriate dose is determined, you may enter the safety expansion cohort.
During this stage, the safety and tolerability of the selected dose are monitored by tracking the frequency and number of adverse events, which are side effects or unwanted medical occurrences.

Who can join the trial?

11 criteria

You must be at least 18 years old.
You must have a confirmed diagnosis of one of the following types of cancer that has returned after treatment or has not responded to treatment: advanced or metastatic ovarian cancer (cancer that has spread), metastatic colorectal cancer (cancer of the colon or rectum that has spread), metastatic pancreatic cancer (cancer of the pancreas that has spread, but not neuro-endocrine tumors), or metastatic melanoma (a type of skin cancer that has spread).
You must have already received standard medical treatments for your advanced cancer and have exhausted all treatment options, meaning no other standard treatments are available.
There must be documented evidence that your disease has progressed, which means your cancer has grown or spread more since your last treatment, based on specific medical measurement rules called RECIST 1.1.
You must have an ECOG performance status of 0 or 1, which means you are generally able to carry out daily activities and light work without much difficulty.
You must be willing to undergo tumor biopsies, which involve taking small samples of cancer tissue for testing, at the start of the study and after two treatment cycles.
You must be able and willing to provide signed informed consent, which means you agree to participate in the study after being fully informed of all the details, risks, and rules.
You must agree to use highly effective contraception (methods like hormonal birth control, an intrauterine device, or other highly reliable ways to prevent pregnancy) to avoid pregnancy during the study and for a set time afterward.
Male participants must use effective contraception from the start of the study until at least 3 months after the last dose of the study drug and must not donate sperm during this time.
Female participants must not be pregnant or breastfeeding; they must either not be able to have children (such as being post-menopausal for at least one year) or agree to use effective contraception until at least 6 months after the last dose and avoid pregnancy treatments like in vitro fertilization.
Female participants who are able to have children must undergo repeated pregnancy testing and must have a negative serum pregnancy test (β-HCG), which is a blood test that checks for pregnancy hormones, within 48 hours before starting the study treatment.

Who cannot join the trial?

35 criteria

You cannot participate if you are known to be allergic or highly sensitive to any of the ingredients used to make the study drug, or to dextrose (a type of sugar).
You cannot be part of another clinical trial at the same time, unless it is a study that only watches patients without giving them new medical interventions.
You cannot have used any investigational agent (a medicine being tested in a study) within 4 weeks before starting this trial.
You cannot participate if you have a history of or current severe dyspnoea (extreme shortness of breath), pulmonary dysfunction (lung problems), or if you need to use continuous oxygen to breathe.
You cannot have received any anticancer therapy, such as chemotherapy (drugs to kill cancer cells), hormonal therapy (treatment using hormones), or radiotherapy (radiation treatment), within 4 weeks before starting the trial. However, certain hormone treatments for prostate cancer, hormone replacement, or birth control are allowed. Also, palliative radiotherapy (radiation used to relieve pain) for bone cancer is allowed if it was done within 2 weeks.
You cannot participate if your blood, liver, or kidney functions are not within healthy ranges. This includes:
If your bilirubin levels (a yellow substance produced by the liver) are too high, unless you have a known harmless condition like Gilbert's syndrome.
If your platelet count (cells that help blood clot) is 100,000 cells/mm³ or lower.
If your absolute neutrophil count (a type of white blood cell that fights infection) is 1,500 cells/mm³ or lower.
If your haemoglobin (a protein in red blood cells that carries oxygen) is 9 g/dL or lower.
If your coagulation (the blood's ability to clot) is abnormal, specifically if your INR or prothrombin time (tests that measure how long it takes blood to clot) are too high.
If your serum creatinine (a waste product filtered by the kidneys) is too high or if your creatinine clearance (a measure of how well kidneys filter blood) is 50 mL/min or lower.
If your serum albumin (a protein made by the liver) is less than 25 g/L.
If your AST or ALT (enzymes that indicate liver health) are too high, unless you have cancer that has spread to the liver.
You cannot participate if you require daily immunosuppressive therapy (medicine that lowers the immune system) or corticosteroids (steroid medicines used to reduce inflammation) for more than 7 days, unless it is an inhaled steroid.
You cannot participate if you have a medical, mental health, or personal situation that, in the doctor's opinion, would make it difficult for you to understand the study, follow the rules, or provide accurate information.
You cannot have a history of autoimmune disease (where the body attacks itself), except for certain stable hormone-related autoimmune issues.
You cannot have received a live vaccine (a vaccine containing a weakened form of a germ) within 30 days of the first dose.
You cannot have a history of inflammatory diseases, such as colitis (inflammation of the bowel), liver fibrosis or cirrhosis (scarring of the liver), or chronic obstructive pulmonary disease (a lung condition that makes breathing difficult).
You cannot have a history of severe vascular disease (problems with blood vessels), such as an aneurysm (a bulge in a blood vessel), deep venous thromboembolic disease (blood clots in the legs), thrombosis (blood clots), myocardial infarction (heart attack), pulmonary embolism (blood clot in the lung), or cerebrovascular accident (stroke).
You cannot weigh more than 100 kg.
You cannot have a history of cardiovascular disease (heart and blood vessel problems), including:
Poorly controlled arterial hypertension (high blood pressure).
Congestive heart failure (the heart cannot pump enough blood) or a low left ventricular ejection fraction (a measurement of how much blood the heart pumps out with each beat).
Uncontrolled cardiac arrhythmia (an irregular heartbeat).
Significant valvular heart disease (problems with the heart valves).
Unstable angina pectoris (chest pain that happens unexpectedly).
You cannot have a history of receiving a solid organ transplant or allogeneic tissue transplant (receiving tissue from another person).
You cannot have used any anti-CD47 or anti-SIRPα drugs (specific types of immune system treatments) before.
You cannot have CNS metastasis (cancer that has spread to the brain or spinal cord) that is untreated or causing symptoms like headaches or seizures, unless it has been stable for at least 6 weeks.
You cannot be undergoing treatment for an active infection; all infection treatments must have ended at least 7 days before starting the study.
You cannot have AIDS, HIV requiring treatment, or active hepatitis A, B, or C (liver infections), unless your hepatitis B or C is well-controlled with medicine.
You cannot have an active SARS-CoV-2 (COVID-19) infection.
You cannot have a history of another primary malignancy (a different type of cancer), except for certain skin cancers, early-stage breast cancer, or certain slow-growing prostate cancers that are not currently active.
You cannot have used PD-1/PD-L1 therapies (a type of immunotherapy) within the last 4 months or 5 half-lives.

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Verified sites

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

Verified
Centre Leon Berard
Lyon, France
Verified
Institut Gustave Roussy
Villejuif, France
Responsive
Universitair Ziekenhuis Gent
Gent, Belgium

Trial locations

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Investigated drugs

TAX2 is an experimental treatment being tested in this study to see if it can help fight various types of advanced solid tumors that have not responded well to other treatments. It is administered directly into a person's vein through an infusion.

What is already known about the treatment

H-CYS(SS)-GLU-VAL-SER-GLN-LEU-LEU-LYS-GLY-ASP-ALA-CYS(SS)-OH - This experimental substance is administered as an injection directly into a vein through an intravenous infusion. Currently being studied in early-stage human clinical trials, it is being investigated for its potential to treat advanced or metastatic cancers, such as ovarian, colorectal, pancreatic, and skin melanoma, in patients who have no other treatment options left. This specialized peptide works at a molecular level to target and interfere with the growth and survival of cancer cells. It is classified as an investigational peptide therapy designed to combat solid tumors.

Investigated diseases

Ovarian cancer
This disease occurs when cells in the ovaries grow uncontrollably. It often starts in the ovaries or nearby tissues and can spread to other parts of the abdomen. As it progresses, the abnormal cells may move into the pelvic area or further into the body.
Colorectal cancer
This condition involves the uncontrolled growth of cells in the colon or rectum. It typically begins as small growths called polyps on the inner lining of the digestive tract. Over time, these growths can turn into cancer and spread to surrounding tissues or distant organs.
Pancreatic cancer
This disease develops when cells in the pancreas undergo abnormal changes. It often starts in the ducts or the cells that produce digestive enzymes. As the disease advances, the cancerous cells can invade nearby organs and travel through the blood or lymphatic system.
Cutaneous metastatic melanoma
This is a type of skin cancer that develops from pigment-producing cells called melanocytes. It begins on the skin and can grow deeper into the layers of the tissue. In later stages, the cancer cells break away from the original site and spread to other parts of the body.