BOLSTER: Cholangiocarcinoma (Bile Duct Cancer) Clinical Trial

Yes. To view the BOLSTER trial page on clinicaltrials.gov, please visit https://clinicaltrials.gov/study/NCT05712356#study-overview

As with any investigational drug, there may be side effects that are not yet known. Potential risks to patients include:

• Gastrointestinal bleeding
• Diarrhea
• Pneumonia (lung infection)
• Buildup of fluid in the sac around the heart (pericardial effusion)

The most common side effects that have been seen in patients with pancreatic cancer who received certepetide in combination with gemcitabine and nab-paclitaxel chemotherapy regardless of its dose and its causal relationship included:

• Low levels of white blood cells (neutropenia)
• Low levels of red blood cells (anemia)
• Loss of sensation or weakness of peripheral nerves (nerves located outside of the brain and spinal cord)

Additional side effects seen in patients treated with both certepetide and chemotherapy (gemcitabine and nab paclitaxel) include:

• Fatigue
• Nausea
• Constipation
• Diarrhea
• Hair loss
• Swelling (peripheral edema)
• Abdominal pain
• Vomiting
• Change in taste
• Loss of appetite
• Breathlessness (dyspnea)
• Rash
• Cough
• Low platelets (thrombocytopenia)
• Nosebleeds (epistaxis)

These adverse events are commonly seen with gemcitabine and nab-paclitaxel when given without certepetide. No new or worsened side effects were observed in patients when certepetide was given in combination with gemcitabine and nab-paclitaxel than those observed in patients who received chemotherapy alone.

Allergies to medications like certepetide are considered unlikely, but there is still the possibility of an allergic reaction. A severe allergic reaction could be life-threatening. Please seek treatment immediately and tell the study doctor and study staff if you have any of these symptoms. An allergic reaction could include:

• Rash or hives
• Difficulty breathing or wheezing 
• Sudden changes in blood pressure that may make you feel dizzy or lightheaded
• Swelling around the mouth, throat, or eyes
• Fast pulse
• Sweating

There is a possibility that certepetide might bind to the cells that help blood clot (platelets), although this was not seen in any studies in animals or in patients who have taken certepetide to date. While you are taking part in this study, your blood cell counts will be monitored closely, and you will receive appropriate treatment if you have a low platelet count or are bleeding.

Although very rare in patients with cancer, when many tumor cells are killed rapidly, the blood can develop high levels of uric acid, potassium, and phosphorus, and low calcium levels, which can cause kidney damage. Symptoms include pain, discomfort, or burning when urinating, low urine output, blood in the urine, dull ache on the side of the upper back, loss of appetite, vomiting, cramps, and weakness. This possible side effect, called tumor lysis syndrome, is usually seen within a few days after starting cancer treatment. Subjects will be monitored, and supportive care provided if abnormal laboratory results or symptoms are observed.

Based on animal studies, there is a possibility that certepetide might cause small changes in the testes and/or the tubes that connect the testes to the urethra (epididymis), however this has not been seen in subjects to date.

If you experience any of the above signs or symptoms, you should notify your doctor immediately, as you may need immediate treatment and hospitalization. Your study doctor may give you drugs to treat these symptoms.

Study treatment will continue until your cancer worsens or you have medically unacceptable side effects. Patients may also withdraw from the study at any time and for any reason without penalty or loss of benefits to which you are otherwise entitled.

By choosing to take part in this study, you are giving us permission to use your personal health information that includes health information in your medical records and information that can identify you. Lisata, the Sponsor, is responsible for looking after your personal health information, keeping it confidential, and using it properly. While every effort will be made to protect the confidentiality of your information, absolute confidentiality in clinical trials cannot be guaranteed.

The Sponsor and companies working with the Sponsor will visit the research facility to monitor the clinical study. They will review your records for these visits. Your records may be reviewed by the FDA and the Institutional Review Board (IRB). The IRB is a group of scientists and non-scientists who review the ethics of clinical research. The goal of the IRB is to protect the rights and welfare of study subjects.

The people above who may review your records will do so to make sure the study has been performed the right way. They also want to make sure that your health information has been collected appropriately, or for other reasons that are allowed under the law.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. The website may include a summary of the research results. You can search this website at any time.

You can choose not to take part in this clinical trial. If you decide not to participate in this trial, your other choices may include the following:

• Getting treatment or care for your cancer without being in a study
• Taking part in another cholangiocarcinoma study
• Getting no treatment for cholangiocarcinoma
• Getting cancer comfort care (also called palliative care)

The study doctor will discuss available cancer treatment options, including their risks and benefits, with you.