Study on the Safety and Tolerability of KAND567 and Carboplatin for Women with Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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What is this study about?

This clinical trial is focused on studying the safety and tolerability of a new treatment combination for women with recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The study involves a medication called KAND567, which is a type of drug known as a fractalkine receptor antagonist, and it is being tested in combination with carboplatin, a common chemotherapy drug. The purpose of the study is to determine the best dose of KAND567 to use in combination with carboplatin for future research.

The study is divided into two parts. In the first part, participants will receive increasing doses of KAND567 along with carboplatin to find the most suitable dose for further testing. In the second part, the selected dose will be given to more participants to further assess its safety and tolerability. Participants will receive the treatment through an infusion, which means the medication is given directly into the bloodstream through a vein. The study will monitor the occurrence of any side effects and how well the treatment is tolerated by the participants.

Throughout the study, participants will have regular check-ups to monitor their health, including tests to measure the levels of the drug in their body and assessments of their overall well-being. The study will also evaluate how the treatment affects the participants’ cancer, including any changes in tumor size or progression of the disease. The study aims to provide valuable information that could lead to improved treatment options for women with these types of cancer.

1 joining the study

Upon joining the study, the participant will provide written informed consent. This is a requirement before any study-specific procedures can begin.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying the type of cancer, age, life expectancy, and other health criteria.

A biopsy will be taken before starting treatment to analyze the cancer’s characteristics.

3 treatment phase 1 (phase Ib)

The participant will receive a combination of KAND567 and carboplatin therapy. Carboplatin is administered as a solution for infusion, which means it is given through a vein (intravenous use).

The goal is to evaluate the safety and tolerability of this combination and determine the recommended dose for the next phase.

4 treatment phase 2 (phase IIa)

In this phase, the participant will continue to receive KAND567 and carboplatin at the recommended dose determined in phase 1.

The focus remains on safety and tolerability, with ongoing monitoring of health and any side effects.

5 regular monitoring

Throughout the study, regular monitoring will occur. This includes checking vital signs, conducting laboratory tests, and performing electrocardiograms (ECGs).

The participant’s response to treatment will be evaluated at specific intervals, such as weeks 12 and 18, using established criteria.

6 biopsy and follow-up

A follow-up biopsy will be conducted around week 8 to assess the treatment’s impact on the cancer.

The participant will continue to be monitored for any adverse events or changes in health status.

7 end of study

The study is estimated to conclude by June 2025. At this point, the participant’s overall survival and progression-free survival will be evaluated.

Final assessments will be made to determine the effectiveness and safety of the treatment combination.

Who Can Join the Study?

Must have a type of cancer called high-grade serous or high-grade endometrioid epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, confirmed by a medical test.
Must be at least 18 years old.
Must have a life expectancy of at least 12 weeks.
Women who can have children must use effective birth control during the study and for 6 months after. This includes methods like hormonal pills, patches, injections, implants, IUDs, or permanent solutions like tubal occlusion or vasectomy. Male partners should not donate sperm during this time.
Must be willing and able to follow the study procedures, schedules, and requirements.
Must be able to understand and participate in study-related activities, including reporting outcomes.
Must provide written consent to participate in the study before any study-specific procedures begin.
Must have cancer that has returned, defined as a first relapse 3 to 6 months after the last platinum-based treatment, or a second or third relapse within 6 months after the last platinum-based treatment. Previous treatment with a type of drug called PARPi is allowed. If not previously treated with bevacizumab, it can be included after tumor progression according to local practice.
Must have received platinum-based chemotherapy as the first treatment or for the first relapse that required chemotherapy.
Must have samples available for testing BRCA and HRD status, or agree to have these tests done on tumor tissue.
Must have an ECOG performance status of 0 to 2, which is a scale to assess how the disease affects daily living abilities.
Must have at least one measurable or non-measurable disease according to specific guidelines. Non-measurable disease should be evaluated using GCIG CA 125 criteria, which involves a blood test.
Must be able to take medications by mouth.
Must have adequate organ function, including specific levels of blood cells, kidney function, and liver enzymes.
Must agree to have a biopsy taken before starting treatment and around Week 8 of treatment.

Who Cannot Join the Study?

Patients who do not have recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer cannot participate. This means the cancer has come back after treatment.
Patients who are not female cannot participate, as the study is only for women.
Patients who are not within the specified age range cannot participate. The study is for adults, but the exact age range is not specified here.
Patients who are part of a vulnerable population cannot participate. This usually means people who might need extra protection, like children or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Ucnhnlr Usxyofnztm Hdxhctwy	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	14.04.2023
Norway	Not recruiting	14.04.2023
Sweden	Not recruiting	14.04.2023

Trial locations

Investigated drugs:

Carboplatin

KAND567 is an investigational medication being studied for its potential to treat recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. In this clinical trial, researchers are evaluating how safe and tolerable KAND567 is when used in combination with another cancer treatment. The goal is to find the best dose of KAND567 to use in future studies.

Carboplatin is a chemotherapy medication commonly used to treat various types of cancer, including ovarian cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this trial, carboplatin is used in combination with KAND567 to assess the effectiveness and safety of the combined treatment in patients with recurrent cancer.

Investigated diseases:

Ovarian cancer

Recurrent Epithelial Ovarian Cancer – This type of cancer originates in the cells on the surface of the ovary and is characterized by its return after initial treatment. It often progresses by spreading to nearby tissues and organs within the pelvis and abdomen. The recurrence can occur months or even years after the initial treatment, and it may present with symptoms such as abdominal pain, bloating, and changes in bowel habits. The disease can be challenging to manage due to its tendency to return after treatment.

Recurrent Fallopian Tube Cancer – This cancer begins in the fallopian tubes, which connect the ovaries to the uterus, and is known for its recurrence after initial therapy. It typically progresses by spreading to nearby pelvic organs and tissues. Symptoms may include pelvic pain, abnormal vaginal bleeding, and abdominal swelling. The disease’s recurrent nature makes it difficult to control, often requiring multiple treatment approaches over time.

Recurrent Primary Peritoneal Cancer – This cancer arises in the peritoneum, a thin layer of tissue lining the abdomen, and is similar to ovarian cancer in its behavior and treatment. It is characterized by its return after initial treatment, often spreading within the abdominal cavity. Symptoms can include abdominal pain, bloating, and digestive issues. The recurrent nature of this cancer poses significant challenges in management and treatment.

Trial ID:

2024-515572-13-00

Protocol code:

KAN0007

NCT ID:

NCT06087289

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Tolerability of KAND567 and Carboplatin for Women with Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?