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

A Study to Evaluate Safety and Anti-Tumor Activity of RO7284755 Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors

  • Solid Tumors
Trial Status:

Recruiting

This trial runs in
Countries
  • Belgium
  • Canada
  • Denmark
  • Netherlands
  • Poland
  • Spain
Trial Identifier:

NCT04303858 2019-004022-25 BP41628

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This is an entry-into-human study and will assess the effects of RO7284755 as a single agent and in combination with atezolizumab in adult participants with solid tumors considered responsive to checkpoint inhibition blockade. The maximum duration in the study for each participant will be up to 28 months.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT04303858 , BP41628 , 2019-004022-25 Trial Identifier
      All Gender
      ≥18 Years Age
      No Healthy Volunteers

      How does the BP41628 clinical trial work?

      This clinical trial is recruiting people who have a solid tumour. In order to take part, participants must have a tumour that cannot be removed by surgery and/or has spread to other parts of the body (known as ‘metastatic disease’).

      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 these medicines. 

      How do I take part in this clinical trial?

      To be able to take part in this clinical trial, you must have a solid tumour that cannot be removed by surgery and/or has spread to other parts of the body. If you have previously received certain treatments, you may not be able to take part. You cannot join the trial if you are pregnant or breastfeeding.

      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. 

      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 2

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

      RO7284755 plus atezolizumab

      • The frequency and dose of treatments in Part 2 could follow any of the schedules described for Part 1.
      • Participants in Part 2 may be split into two groups, with RO7284755 given as either an infusion into the vein (Group 1) or an injection under the skin (Group 2). The group selection would be random and would not be decided by you or your doctor. You would have an equal chance of being placed in either group (like flipping a coin). Alternatively, Part 2 may move ahead with RO7284755 being given by only one of the two routes (infusion or injection). Atezolizumab is always given as an infusion into the vein.

      Part 3

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

      RO7284755 alone or RO7284755 plus atezolizumab

      Based on the results of Parts 1 and 2, doctors will decide the best way to give RO7284755 (the frequency of treatment, the benefits of increasing or splitting dosing, and the best method of administration – infusion or injection under the skin). All participants in Part 3 will receive RO7284755 this selected way. The clinical trial doctors will decide which treatment you receive based on your disease. 

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

      You will be given the clinical trial treatment RO7284755, either alone or together with atezolizumab, for as long as it can help you, up to a maximum of 24 months. You are free to stop this treatment at any time. At the end of the treatment period, you will be seen by the clinical trial doctor after three months, and will then be contacted by the clinical trial team over telephone every three months. This will include checks for any side effects that you may be having.

      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 https://clinicaltrials.gov/ct2/show/NCT04303858

      Trial-identifier: NCT04303858

      Trial Summary

      This is an entry-into-human study and will assess the effects of RO7284755 as a single agent and in combination with atezolizumab in adult participants with solid tumors considered responsive to checkpoint inhibition blockade. The maximum duration in the study for each participant will be up to 28 months.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT04303858 , BP41628 , 2019-004022-25 Trial Identifier
      RO7284755, Atezolizumab Treatments
      Solid Tumors Condition
      Official Title

      An Open-Label, Multicenter, Randomized, Dose-Escalation and Extension, Phase IA/IB Study to Evaluate Safety and Anti-Tumor Activity of RO7284755, A PD-1 Targeted IL-2 Variant (IL-2V) Immunocytokine, Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Locally advanced/unresectable or metastatic disease
      • Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
      • Eastern Cooperative Oncology Group Performance Status 0 to 1
      • Life expectancy of >=12 weeks
      • Consent to provide an archival tumor tissue sample
      • Adequate cardiovascular, hematological, coagulative, hepatic and renal function
      Exclusion Criteria
      • Rapid disease progression or suspected hyperprogression or threat to vital organs or critical anatomical sites requiring urgent alternative medical intervention
      • Untreated central nervous system (CNS) metastases
      • Treated asymptomatic CNS metastases
      • Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 2 weeks before Cycle1 Day 1 (C1D1)
      • Active or history of carcinomatous meningitis/leptomeningeal disease
      • Uncontrolled tumor-related pain or symptomatic hypercalcemia
      • Concurrent second malignancy
      • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
      • Episode of significant cardiovascular/cerebrovascular acute disease within 28 days before study treatment administration
      • Active or uncontrolled infections
      • Known HIV infection
      • Hepatitis B virus (HBV) or hepatitis C virus infection
      • Adverse events related to any prior radiotherapy, chemotherapy, targeted therapy, CPI therapy or surgical procedure must have resolved to Grade <=1, except alopecia Grade 2 peripheral neuropathy, and hypothyroidism and/or hypopituitarism on a stable dosage of hormone replacement therapy
      • Participants with bilateral pleural effusion
      • Major surgery or significant traumatic injury < 28 days before study treatment administration or anticipation of the need for major surgery during study treatment
      • Known allergy or hypersensitivity to any component of the formulations of the IMPs to be administered, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant or humanized antibodies
      • History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
      • Previous treatment with Interleukin-2 (IL-2)/Interleukin-5 (IL-15)-like cytokines. IL-2/IL-15 use as an adjunct treatment component for adoptive cell therapy is permitted.

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