Study on the Safety and Effects of OBT076 and Balstilimab in Patients with Recurrent or Metastatic CD205-Positive Solid Tumors

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What is this study about?

This clinical trial is focused on studying certain types of cancer, specifically those that are CD205-positive. These include cancers such as gastric cancer, non-small cell lung cancer (NSCLC), endometrial cancer, and ovarian cancer. The study is exploring the effects of a new treatment called OBT076, which is a special type of medicine known as a monoclonal antibody. This medicine is designed to target and attach to a specific protein found on cancer cells, helping to deliver a drug directly to the cancer. The study will also look at how OBT076 works when used alone and in combination with another drug called balstilimab.

The purpose of this study is to determine how safe and tolerable OBT076 is for patients, both on its own and when combined with balstilimab. Participants in the study will receive the treatment through an intravenous infusion, which means the medicine is given directly into a vein. The study will monitor patients over a period of time to see how their bodies respond to the treatment and to find the best dose that can be given safely. The study will also look at how the treatment affects the cancer and whether it can help control the disease.

Throughout the study, researchers will collect information on how the treatment affects the body, including any side effects that may occur. This information will help determine the most effective and safe way to use OBT076, either alone or with balstilimab, for treating these types of cancers. The study aims to provide new insights into potential treatment options for patients with recurrent or metastatic cancers that are positive for the CD205 protein.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The patient must sign an informed consent form (ICF) before any study-related assessments or procedures are conducted.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying the presence of CD205-positive recurrent or metastatic solid tumors and ensuring the patient meets all inclusion criteria.

3 treatment phase

The patient will receive the study drug OBT076, which is a solution for infusion administered intravenously. The dosage and frequency will be determined based on the study’s dose-finding objectives.

In some cases, the patient may also receive balstilimab in combination with OBT076. The combination aims to assess safety and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

4 monitoring and follow-up

Throughout the study, the patient will be monitored for safety and tolerability. This includes regular health assessments and laboratory tests to evaluate the effects of the treatment.

The patient will also be assessed for preliminary efficacy, which involves measuring response rates and disease stability.

5 end of treatment

Upon completion of the treatment phase, the patient will undergo a final assessment to evaluate overall health and any long-term effects of the study drug.

The patient will be advised on any necessary follow-up care or additional monitoring required after the study concludes.

Who Can Join the Study?

The patient must be 18 years or older and have a type of cancer that cannot be cured, has come back, or has spread to other parts of the body.
The patient must have tried standard treatments that did not work or have no other good treatment options.
The patient must understand and sign a form agreeing to participate in the study before any study-related activities begin.
The patient must be able to follow the study schedule and meet other study requirements.
If the patient is a woman who can have children, she must:
- Have a negative pregnancy test before starting the study.
- Use a reliable form of birth control during the study and for at least 4 months after the last dose of the study drug.
- Agree not to donate eggs during the study and for at least 4 months after the last dose of the study drug.
- Agree not to breastfeed or become pregnant during the study and for at least 4 months after the last dose of the study drug.
If the patient is a man who is sexually active, he must:
- Use a condom with sperm-killing products during the study and for at least 4 months after the last dose of the study drug.
- Agree not to donate sperm during the study and for at least 4 months after the last dose of the study drug.
- Agree not to father a child during the study and for at least 4 months after the last dose of the study drug.
The patient must have a confirmed diagnosis of a solid tumor, which is a type of cancer that forms in solid organs or tissues.
For breast cancer patients:
- If the cancer is hormone-receptor positive, the patient must have tried at least two previous hormone treatments.
- If the cancer is HER2 negative, the patient must meet specific criteria based on recent tests.
- If the cancer is triple negative, the patient must have tried at least one previous chemotherapy treatment.
The patient must have tried no more than two previous chemotherapy treatments for cancer that has spread.
The patient’s tumor must test positive for a specific marker called CD205.
The patient must have a good performance status, meaning they are able to carry out daily activities with little or no assistance.
The patient must have a tumor that can be measured using imaging tests.
The patient must have adequate organ function, meaning their liver, kidneys, and other organs are working well enough to participate in the study.
The patient must have adequate bone marrow function, meaning their blood cell levels are within a safe range.

Who Cannot Join the Study?

Patients with certain types of tumors that do not have the specific marker CD205+ve. This marker is a specific protein found on some cancer cells.
Patients who have not experienced a recurrence or spread of their cancer. Recurrent means the cancer has come back after treatment, and metastatic means the cancer has spread to other parts of the body.
Patients who are not within the specified age range for the study.
Patients who are not able to safely tolerate the study medications, which means they might have severe side effects or reactions.
Patients who are part of a vulnerable population, which includes groups that might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
University General Hospital Of Heraklion	Heraklion	Greece
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Hm Nou Delfos	Barcelona	Spain
University General Hospital “ATTIKON”- General Hospital of West Attica “H AGIA VARVARA”	Athens	Greece
Humjjwky Uhnkrgbijxeyk Mdxtubz Dc Vptjvjbxnq	Santander	Spain
Lmchy Gvnqugi Hgyyyfdk Od Aedhnn	Athens	Greece
Asczsqmboz Ppjywjlo Hflsostq Dk Pvfla	Paris	France
Gbufzx Hbqjezopmcc Uxuimxccfmnue Pdllf Ptoqbeofjch Eh Nxabzxhoapgp	Paris	France
Idflhtdn Pejkqhrkgxinmzk Csusqu Ctrhee	Marseille	France
Hinbsbqk Uzcuzczrsuiquh Sguwmhanex &nehvzd Hykrbkc db Holthcfunom	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	13.10.2022
France	Recruiting	13.10.2022
Greece	Recruiting	13.10.2022
Spain	Recruiting	13.10.2022

Trial locations

Investigated drugs:

OBT076 is an experimental medication being studied for its potential to treat certain types of cancer. It is a type of drug known as an antibody-drug conjugate, which means it combines an antibody with a drug to specifically target and attack cancer cells that have a protein called CD205 on their surface. This medication is being tested to see if it is safe and how well it works in people with solid tumors that have returned or spread.

Balstilimab is another medication being tested in combination with OBT076. It is a type of drug known as an immune checkpoint inhibitor. This means it helps the body’s immune system recognize and attack cancer cells more effectively. The combination of balstilimab with OBT076 is being studied to see if it can improve the treatment outcomes for patients with certain types of cancer.

Investigated diseases:

Neoplasm malignant

Gastric Cancer – Gastric cancer, also known as stomach cancer, begins in the cells lining the stomach. It often starts in the mucus-producing cells on the stomach’s inner surface. As it progresses, it can invade deeper layers of the stomach wall and spread to nearby organs. Symptoms may include indigestion, stomach pain, nausea, and weight loss. The disease can spread to lymph nodes and other parts of the body. Early detection is challenging due to subtle initial symptoms.

Non-Small Cell Lung Cancer (NSCLC) – Non-small cell lung cancer is the most common type of lung cancer, accounting for about 85% of cases. It typically starts in the epithelial cells lining the lungs. The disease progresses by forming tumors that can grow and spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As it advances, it can affect the lymph nodes and other organs. Early stages may not present noticeable symptoms, making early detection difficult.

Endometrial Cancer – Endometrial cancer originates in the lining of the uterus, known as the endometrium. It is the most common type of uterine cancer. The disease often presents with abnormal vaginal bleeding, especially after menopause. As it progresses, it can invade the uterine wall and spread to nearby tissues. Symptoms may also include pelvic pain and weight loss. Early detection is possible due to noticeable symptoms in many cases.

Ovarian Cancer – Ovarian cancer begins in the ovaries, which are the reproductive glands that produce eggs. It often goes undetected until it has spread within the pelvis and abdomen. Symptoms can include bloating, pelvic pain, and changes in bowel habits. The disease progresses by forming tumors that can spread to other parts of the body. Early stages may not cause noticeable symptoms, making early detection challenging. It is often diagnosed at an advanced stage due to subtle initial symptoms.

Trial ID:

2024-511884-27-00

Protocol code:

OBT076-001

NCT ID:

NCT04064359

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effects of OBT076 and Balstilimab in Patients with Recurrent or Metastatic CD205-Positive Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?