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A study to evaluate the safety of SGN-ALPV in patients with advanced solid tumors

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What is this trial about?

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

This study aims to evaluate the safety and the best dose of a new drug called SGN-ALPV. The research focuses on patients with Advanced Solid Tumors, which are types of cancer that have spread or grown significantly in various parts of the body. The specific types of cancer being studied include Gastroesophageal Junction Carcinoma, which is cancer located where the esophagus meets the stomach, Non-small cell lung cancer, Gastric cancer, Cervical cancer, Ovarian cancer, and Endometrial cancer. The study also includes certain types of Malignant Ovarian Germ Cell Tumor, Malignant Testicular Germ Cell Tumor, and Malignant Extragonadal Germ Cell Tumor, which are cancers that arise from specific types of cells known as germ cells.

The treatment involves the intravenous administration of SGN-ALPV, meaning the medicine is delivered directly into a vein through a needle or tube. Participants in the study will receive the drug in different amounts to help researchers determine the highest dose that can be given safely without causing too many side effects. During the study, medical professionals will monitor how the body reacts to the medication and how much of the drug remains in the bloodstream over time.

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
Administration of the study medication
The medication sgn-alpv is administered through an intravenous injection, which means it is delivered directly into a vein.
The dose provided is 2.5 mg/kg, where the amount depends on body weight (milligrams per kilogram).
Step 2
Monitoring and safety evaluation
The process involves monitoring for adverse events, which are any unexpected or harmful medical occurrences, and laboratory abnormalities, which are changes in blood or other test results.
The frequency and amount of the medication are assessed to find the maximum tolerated dose, which is the highest amount that can be given without causing unacceptable side effects.
The study tracks dose-limiting toxicities, which are specific side effects that prevent an increase in the medication dose.

Who can join the trial?

11 criteria

You must be 18 years of age or older.
You must have a type of cancer that has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable).
The cancer must be confirmed by looking at cells under a microscope (histologically or cytologically confirmed).
The types of cancer allowed include ovarian cancer, endometrial cancer (cancer of the lining of the uterus), non-small cell lung cancer, gastric cancer (stomach cancer), or cancer at the gastroesophageal junction (where the esophagus meets the stomach), cervical cancer, or certain germ cell tumors (tumors that start from cells that normally become eggs or sperm), except for pure teratomas (a specific type of germ cell tumor).
For high-grade serous ovarian cancer, your cancer must have grown or returned within 6 months after receiving platinum-containing chemotherapy, you must have had 2 to 4 previous cancer treatments, and at least one of those treatments must have been for platinum-resistant cancer (cancer that does not respond to platinum drugs). You must also have received at least one treatment containing bevacizumab.
For endometrial cancer, the cancer must be locally advanced (has spread to nearby tissues) or metastatic, and you must have had at least one previous cancer treatment.
For non-small cell lung cancer, the cancer must be locally advanced or metastatic, and you must have previously received platinum-based therapy and a PD-(L)1 inhibitor (a type of immunotherapy).
For gastric cancer or gastroesophageal junction cancer, the cancer must be locally advanced or metastatic, and you must have previously received chemotherapy using platinum and fluoropyrimidine.
You must agree to have a biopsy, which is a procedure to remove a small piece of tissue for testing. This may need to be done before treatment starts and sometimes during the first cycle of treatment.
You must have an ECOG performance status of 0 or 1, which means you are physically able to carry out light work or daily activities and are mostly active.
You must have measurable disease, meaning the tumors can be clearly seen and measured on medical scans using specific standardized rules (RECIST v1.1).

Who cannot join the trial?

4 criteria

Having another type of cancer within 3 years of receiving the first dose of the study treatment, or having any sign that a previous cancer is still present in the body, unless that cancer is considered to have a very low risk of spreading or causing death.
Having metastases, which are areas where cancer has spread, that are currently active in the central nervous system (the brain and spinal cord).
Having previously taken a medicine that contains MMAE (a type of chemotherapy drug) or a medicine that targets specific proteins called ALPP or ALPPL2.
Having neuropathy, which is nerve damage that causes numbness, tingling, or pain, that is rated as Grade 2 or higher according to standard medical severity scales.

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Verified sites

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

Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Verified
Institut Catala D'oncologia
L'hospitalet De Llobregat, Spain
Verified
Karolinska University Hospital
Solna, Sweden

Trial locations

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Investigated drugs

SGN-ALPV is an experimental treatment being tested to see if it is safe and how well patients can tolerate it when treating advanced solid tumors. It is given directly into a vein through an injection.

SGN-ALPV

What is already known about the treatment

SGN-ALPV - This medication is an experimental drug provided as a freeze-dried powder that is mixed and then given directly into a vein through an injection. It is currently being studied in clinical trials to see how well it works against various advanced solid tumors, including certain types of lung, stomach, and reproductive cancers. This drug belongs to a class of targeted therapies that uses specialized molecules to find and attach to specific proteins on the surface of cancer cells. Once attached, it works by delivering a powerful treatment directly into the cancer cells to destroy them while aiming to limit damage to healthy parts of the body.

Investigated diseases

Gastroesophageal junction carcinoma
This is a type of cancer that develops at the area where the esophagus meets the stomach. It begins when abnormal cells grow uncontrollably in the tissues of this junction. As the disease progresses, these cells may invade deeper layers of the organ walls. The abnormal growth can eventually spread to nearby structures or other parts of the body.
Non-small cell lung cancer
This is a common form of lung cancer that includes several different subtypes. It starts when cells in the lungs undergo genetic changes that cause them to multiply rapidly. The disease can involve the lining of the airways or the lung tissue itself. Over time, the cancerous cells may expand and spread beyond the initial site in the lungs.
Gastric cancer
This disease involves the uncontrolled growth of abnormal cells within the stomach lining. It typically starts in the mucosal layer of the stomach. As the condition advances, the tumor can grow into the deeper layers of the stomach wall. It may also move to other organs through the bloodstream or lymphatic system.
Cervical cancer
This type of cancer originates in the cells of the cervix, which is the lower part of the uterus. It often begins with changes in the cells that line the cervical canal. These abnormal cells can gradually transform into cancerous cells over time. The disease can then spread to the vaginal walls or other pelvic organs.
Ovarian cancer
This cancer develops from cells within the ovaries, which are the female reproductive organs. It starts when cells in the ovaries begin to divide abnormally. The disease can progress by forming masses within the ovaries or on their surfaces. It may eventually involve the fluid-filled spaces in the abdomen.
Endometrial cancer
This is a cancer that begins in the endometrium, which is the inner lining of the uterus. It occurs when cells in this lining grow in an uncontrolled manner. As the disease moves forward, the cancerous layer can thicken and invade the muscular wall of the uterus. It may also spread to nearby pelvic tissues.