A clinical trial to look at how safe RO7284755 is at different doses and how well RO7284755 alone or together with atezolizumab works to reduce solid tumours

1. How does the BP41628 clinical trial work?

This clinical trial is recruiting people who have a solid tumour and have no standard treatments available or cannot be given standard treatments.

The aims of this clinical trial are to test different doses of RO7284755 alone or together with atezolizumab to determine how safe the treatment is, and how well it works to reduce solid tumours, and to understand the way your body processes RO7284755 and atezolizumab.

2. How do I take part in this clinical trial?

People can take part in this clinical trial if they have a solid tumour that cannot be removed by surgery and/or has spread to other parts of the body (known as ‘metastatic disease’) and have no standard treatments available or cannot be given standard treatments.

People cannot take part if they have been given certain treatments before or within a certain timeframe, such as other investigational ‘clinical trial’ drugs or some types of immunotherapies. Women who are pregnant or breastfeeding or people who had severe side effects to previous immunotherapy cannot take part in this trial.

If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, they may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about joining the clinical trial and providing your consent to take part. You can also find the clinical trial locations on this page.

You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be repeated.

Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.

While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or use adequate contraception for safety reasons.

3. What treatment will I be given if I join this clinical trial?

This trial consists of three parts. Everyone who joins the trial will be placed into one part only, depending on the time you join the trial.

Part 1
In this part of the clinical trial everyone will be given:

RO7284755 alone

• RO7284755 given every week for the first six weeks (called induction), then every three weeks after that (called maintenance). 
• Depending on how participants are responding to the treatment, doctors may change the frequency of RO7284755 treatments and the way the dose is given in the next set of participants:
  • The maintenance treatment of RO7284755 may be given every two weeks, after the initial six-week induction
  • RO7284755 may be given every three weeks from the start (without the initial six-week induction)
    • Doctors may introduce pre-medication routines if RO7284755 is given every three weeks
  • The dose of RO7284755 may be increased after the first treatment
  • The dose of RO7284755 may be split/fractioned (e.g. half dose or a fraction of the dose on Day 1 and the other half/fraction on Day 5)
• Participants in Part 1 will also be split into two groups and RO7284755 will be given as either an infusion into the vein (Group 1) or an injection under the skin (Group 2). The group selection is random and cannot be decided by you or your doctor. You will have an equal chance of being placed in either group (like flipping a coin).

Part 1 of this clinical trial has been completed.

Part 2
Based on the results of Part 1, everyone in Part 2 of this clinical trial will be given:

RO7284755 plus atezolizumab

• RO7284755 will be given every three weeks as an infusion into the vein
  • The dose of RO7284755 will be split/fractioned (half dose or a fraction of the dose on Day 1 and the other half/fraction on Day 5)
• Atezolizumab will be given as an infusion into the vein every three weeks, on the same day as the first dose of RO7284755.

Part 3
In this part of the clinical trial, everyone will be given:

RO7284755 alone or RO7284755 plus atezolizumab

How often treatment is given in Part 3 is based on the results of Parts 1 and/or Part 2. All participants in Part 3 will receive RO7284755 as an infusion into the vein, with a half dose or a fraction of the dose on Day 1 and the other half/fraction on Day 5.

4. How often will I be seen in follow-up appointments and for how long?

Participants will be given the clinical trial treatment RO7284755, either alone or together with atezolizumab, for, up to a about two years or longer if certain conditions are met and if the treatment benefits them. Participants can stop trial treatment and leave the clinical trial at any time. At the end of the treatment period, participants will be seen by the clinical trial doctor every three months for the first nine months, and after that, may be contacted by the clinical trial team over the telephone every three months. This will include checks for any side effects that they may be having.

5. What happens if I am unable to take part in this clinical trial?

If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov

Trial-identifier: NCT04303858