RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)

This research study is investigating a new medication called ART6043, which is an anti-cancer drug. It's being tested either on its own or together with another approved cancer drug called olaparib. The study is for people with advanced or metastatic solid tumours, which means cancers that have spread or are at a later stage. The main goals are to check if ART6043 is safe, how well people tolerate it, how it moves through the body, and if there are any early signs that it helps to shrink tumours or slow their growth. The study is particularly interested in cancers with specific genetic changes that affect how the body repairs damaged DNA, as the drugs being tested are designed to target these weaknesses. It's divided into phases to find the best dose and then to look more closely at its effects.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Artios Pharma Ltd

Enrolment target

181

Start

30 Jun 2023

Estimated completion

30 Sep 2028

Advanced Solid Tumor Metastatic Solid Tumor

What is this study about?

This study is looking into a new anti-cancer drug called ART6043. It's designed to help treat advanced or metastatic solid tumours, which are cancers that have grown or spread to other parts of the body. The research team wants to find out if ART6043 is safe, how well people tolerate it, and how it behaves in the body. They also want to see if it shows any early signs of helping to treat these cancers. This new drug is being tested both on its own and in combination with an existing cancer drug called olaparib.

Olaparib is a type of drug that works by targeting a specific weakness in some cancer cells related to how they repair damaged DNA. ART6043 is thought to work in a similar way, or to boost the effects of olaparib. The study is especially interested in people whose cancers have certain genetic changes that affect how their DNA is repaired. By targeting these weaknesses, the aim is to damage the cancer cells more effectively while hopefully causing less harm to healthy cells.

The study has two main parts. The first part (Part A) is about finding the safest and most effective dose of ART6043, both when given alone and when given with olaparib. The second part (Part B) will then look more closely at the safety and initial effectiveness of ART6043 when combined with olaparib, specifically in a group of people with a particular type of advanced breast cancer who have a known genetic fault. Patients will continue treatment for as long as it is helping, and they are not experiencing severe side effects.

Key takeaways

This study tests a new cancer drug, ART6043, for advanced solid tumours.
It might be given alone or with an existing drug, olaparib.
It focuses on cancers with certain genetic weaknesses in DNA repair.
The study aims to find safe doses and check if the treatment is effective.
You'll have regular checks and scans to monitor your health and tumour changes.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would generally need to have advanced or metastatic solid tumours. You should have recovered from any side effects of previous cancer treatments or surgeries before joining. Your general health and fitness level, measured by a scale called ECOG, should be good (scores of 0 to 2).

There are also specific requirements depending on which part of the study you might join. For some parts, your cancer might need to have certain genetic changes that affect how your body repairs DNA. For a specific part focusing on breast cancer, you would need to have advanced breast cancer that doesn't overproduce HER2 protein and have a specific inherited gene fault called a BRCA mutation.

All participants must be at least 18 years old and expected to live for at least 12 more weeks. If you or your partner could have children, you would need to use effective birth control during the study. You'd also need to have good function of your organs like your liver and kidneys. Your medical team can help determine if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have advanced or metastatic solid tumour?
Have I recovered from side effects of previous cancer treatments?
Is my general health good enough for a study (ECOG 0-2)?
Am I at least 18 years old?
Am I willing to use effective birth control if applicable?
Has my doctor discussed if my cancer has specific DNA repair gene changes?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either the new drug ART6043, or ART6043 with olaparib, or olaparib alone, depending on the study part and what your doctor thinks is best for you. These drugs are typically taken by mouth. You will have regular hospital visits for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects. The visits will be more frequent at the beginning and might become less frequent if the treatment is stable.

The study will involve several medical assessments, including physical exams, blood samples, urine samples, and imaging scans (like CT or MRI scans) to measure your tumour size. You may also be asked about how you are feeling and any symptoms you have. You will continue to receive the study treatment for as long as your doctors believe it is helping you and as long as you are not experiencing unacceptable side effects. If the treatment stops working or causes too many problems, you would stop taking the study drugs.

The total duration of your participation will vary. Some people might be on the study drugs for months or even longer if the treatment is effective and well-tolerated. After you stop taking the study drugs, there will be follow-up appointments to monitor your health. The study team will explain the full schedule of visits and tests during the informed consent process.

Potential risks and benefits

Like all medical treatments, there's a chance this study might help you by slowing down or shrinking your cancer. It's also possible that you may not benefit from the new treatment. However, by taking part, you'll be contributing to important medical research that could help others in the future. On the other hand, there are potential risks, as the drugs may cause side effects, some of which could be serious. The study team will monitor you closely for any side effects and will explain all known and possible risks in detail before you decide to join. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (27)

South Texas Accelerated Research Therapeutics (START) - Midwest
Verified postcode
Grand Rapids, United States· Active not recruiting
Memorial Sloan-Kettering Cancer Center (MSKCC)
Verified postcode
New York, United States· Active not recruiting
Stephenson Cancer Center - Oncology
Verified postcode
Oklahoma City, United States· Active not recruiting
Jefferson University Hospitals - Kimmel Cancer Center
Verified postcode
Philadelphia, United States· Active not recruiting
SCRI oncology partners
Verified postcode
Nashville, United States· Completed
Mary Crowley Cancer Center - Clinic
Verified postcode
Dallas, United States· Completed
The University of Texas - MD Anderson Cancer Center
Verified postcode
Houston, United States· Active not recruiting
Hospital Universitario Clínico San Cecilio
Verified postcode
Granada, Spain· Recruiting
Hospital Clínico Universitario de Valladolid
Verified postcode
Valladolid, Spain· Recruiting
Hospital de la Santa Creu i Sant Pau
Verified postcode
Barcelona, Spain· Recruiting
Hospital San Pedro de Alcántara
Verified postcode
Cáceres, Spain· Recruiting
Hospital Universitario 12 de Octubre
Verified postcode
Madrid, Spain· Recruiting

Common questions

What kind of cancer does this study focus on?

This study is for people with advanced or metastatic solid tumours, which are cancers that have grown or spread. It's particularly interested in certain types of breast cancer and cancers with specific genetic changes related to DNA repair.

What are ART6043 and olaparib?

ART6043 is a new anti-cancer drug being tested. Olaparib is an existing cancer drug, sometimes called a PARP inhibitor. Both are designed to target weaknesses in cancer cells, especially those with certain DNA repair problems.

Will I definitely get the new drug ART6043?

Not necessarily. Depending on which part of the study you join, you might receive ART6043 alone, ART6043 with olaparib, or olaparib alone. The study team will explain this to you.

How long would I be on this study for?

The time spent on the study drugs varies. You would continue treatment for as long as it's helping you and you're not experiencing severe side effects. This could be months or longer. There will also be follow-up appointments after stopping the drugs.

Can I leave the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

Artios Pharma

info@artios.com +44 (0)1223 867 900 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.