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RecruitingPHASE1INTERVENTIONAL

To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors

This research is looking at a new treatment, DAY301, for people with advanced or metastatic solid cancers. These are cancers that have grown or spread to other parts of the body. DAY301 is a special type of drug that combines a targeted antibody with a chemotherapy drug. The study has two main parts: first, researchers will slowly increase the dose of DAY301 in different groups of people to find the safest and most effective amount to give. Second, once a suitable dose is found, more people with specific types of advanced cancer will receive DAY301 to further check its safety and see how well it works against their tumours. The main goal is to understand its safety and whether it can help to control cancer.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Day One Biopharmaceuticals, Inc.
Enrolment target
254
Start
18 Nov 2024
Estimated completion
01 Dec 2028

What is this study about?

This study is a clinical trial exploring a new medicine called DAY301. It's designed for people who have advanced or metastatic solid tumours, which means their cancer has grown beyond its original site or spread to other parts of the body. The main purpose of this research is to carefully check if DAY301 is safe to use and to understand its potential side effects. Researchers will also be looking to see if the medicine has any positive effects on the tumours.

DAY301 is a type of drug called an 'antibody-drug conjugate'. This means it's designed to deliver a cancer-fighting medicine directly to cancer cells while trying to limit harm to healthy cells. It does this by targeting a specific protein called PTK7, which is often found in higher amounts on various cancer cells. By attaching to PTK7, DAY301 aims to deliver its anti-cancer punch more precisely.

This study is in its early stages (Phase 1). This means it's typically the first time the new medicine is being tested in humans. It will happen in two steps: first, small groups of people will receive increasing doses of DAY301 to find the safest dose and understand the side effects. Then, once a safe dose is identified, more people will take part to gather more information on safety and to see if the medicine helps against their specific type of cancer.

Key takeaways

  • This is an early-stage study (Phase 1) of a new cancer medicine called DAY301.
  • It's for people with certain types of advanced or metastatic solid tumours.
  • The main goals are to find a safe dose and understand potential side effects.
  • Researchers will also look for signs that DAY301 might help control the cancer.
  • You would receive DAY301 and have regular check-ups and tests.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, your doctor would need to confirm that you have an advanced or metastatic solid tumour. This includes specific types of cancer such as ovarian, oesophageal, triple-negative breast cancer, non-small cell lung cancer, small cell lung cancer, head and neck cancer, stomach cancer, cervical cancer, or endometrial cancer. You must have already tried standard treatments, or there might not be any other standard treatments available for your cancer. Your medical team would also need to be able to get a sample of your tumour tissue (either an existing sample or a new biopsy) to help them understand more about your cancer.

There are also some things that might mean you can't take part. For example, if you've already had a different treatment that targets the PTK7 protein for Phase 1a, or other specific related treatments for Phase 1b, you wouldn't be eligible. Some specific types of ovarian cancer or cancers in the nose and throat area (nasopharyngeal tumours) might also prevent you from joining certain parts of the study. Also, if you've recently had certain bowel problems, or issues with fluid build-up in your abdomen that needs frequent draining, you might not be able to participate. Your overall health and how well your organs are working will also be checked.

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.

  1. I have an advanced or metastatic solid tumour of a specific type (e.g., ovarian, breast, lung, stomach).
  2. I have already tried standard treatments, or no standard treatments are available for my cancer.
  3. My doctor can provide a sample of my tumour tissue.
  4. I am in reasonably good general health (ECOG 0 or 1).
  5. I haven't had previous treatments targeting PTK7 or related drugs for certain phases of the study.
  6. I don't have certain recent bowel problems or frequent fluid build-up in my abdomen.
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medicine, DAY301. Initially, for the first part of the study, you'll be in a group where the dose of DAY301 will be slowly increased. This is done to find the safest and most effective dose. You will have regular visits to the clinic for check-ups, blood tests, and scans to monitor your health, look for any side effects, and see how the treatment is affecting your cancer. These visits will likely be more frequent at the beginning of the study. Once the safest dose is found, other participants will then receive this dose to gather more information. The total duration of your participation would depend on how well you respond to the treatment and whether you experience any side effects, but patients typically remain on study treatment for several months or longer. Your doctor will explain how often you would need to attend appointments and what tests you would have.

Potential risks and benefits

Participating in a clinical trial like this offers the potential benefit of accessing a new treatment that isn't yet widely available, which might help control your cancer, especially if standard treatments haven't worked or aren't an option. However, as with any new medicine, there are potential risks. DAY301 may cause side effects, some of which could be serious or unexpected. These will be carefully monitored by the study team. It's important to remember that new treatments don't always work for everyone, and there's no guarantee of benefit. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

  • Site: 001-058
    Verified postcode
    New Haven, United States· Recruiting
  • Site: 001-063
    Verified postcode
    Lake Mary, United States· Recruiting
  • Site: 001-064
    Verified postcode
    Sarasota, United States· Recruiting
  • Site: 001-060
    Verified postcode
    Indianapolis, United States· Recruiting
  • Site: 001-059
    Verified postcode
    Grand Rapids, United States· Recruiting
  • Site: 001-039
    Verified postcode
    New York, United States· Recruiting
  • Site: 001-073
    Verified postcode
    Oklahoma City, United States· Recruiting
  • Site: 001-065
    Verified postcode
    Nashville, United States· Recruiting
  • Site: 001-069
    Verified postcode
    Houston, United States· Recruiting
  • Site: 001-057
    Verified postcode
    San Antonio, United States· Recruiting
  • Site: 011-013
    Verified postcode
    Vancouver, Canada· Recruiting
  • Site: 011-005
    Verified postcode
    Toronto, Canada· Recruiting

Common questions

What is DAY301?

DAY301 is a new experimental medicine being tested for advanced cancers. It's designed to specifically target and attack cancer cells.

What does 'Phase 1' mean?

Phase 1 means this is an early study, primarily focused on finding a safe dose and understanding the side effects of a new medicine in people for the first time.

Will DAY301 cure my cancer?

It's too early to say if DAY301 will cure cancer. The study aims to see if it can help control the cancer and improve symptoms.

What kind of side effects might I experience?

As DAY301 is a new medicine, the exact side effects are still being learned. The study team will closely monitor you for any effects and explain them to you.

Can I continue with my usual treatments?

It's likely you will only receive DAY301 as your main cancer treatment if you are in the study. Your medical team will discuss this with you.

How to find out more

Day One Clinical Trials Information

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

Interested in taking part?

Register your interest

Share your details and the research team for "To Evaluate the Safety, Tolerability, Pharmacokinetics and A…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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