AZD3965: a phase 1 trial looking at a new treatment called AZD3965 for people with relapsed or refractory lymphoma and for other cancers

This is a phase 1 (early phase) trial of an experimental treatment. Little is known about the safety and effectiveness of this treatment. You might not benefit from the treatment but the trial will give important information about this new treatment, which could help other people in the future. 


Purpose of trial

The aim of this trial is to find out more about using a new treatment called AZD3965 to treat lymphomas and other types of cancer. The trial is for people whose lymphoma has relapsed (come back) or is refractory (has not responded to treatment) and for people with advanced-stage solid tumours.

The trial aims to find out:

  • the best dose to use
  • the side effects
  • how well the treatment works
  • how the treatment behaves in the body.

Treatments

AZD3965 is a targeted drug that works by blocking the action of a protein called monocarboxylate transporter 1 (MCT1). MCT1 is involved in transporting substances in and out of cells. Blocking this protein in cancer cells with AZD3965 could cause the cells to die or control their growth.

Everyone in this trial takes AZD3965 every day.

AZD3965 is a capsule that you take once or twice a day, depending which dose you are taking. Different doses are being tested in this trial.

This trial is in two parts.

  • Part 1 is to find out the highest safe dose of AZD3965. People with lymphoma and any other type of solid cancer can enter this part of the trial. Participants are treated in small groups. The first few participants have the lowest dose of AZD3965. The next few have a higher dose. This continues and the participants are monitored closely for side effects. The highest dose that doesn’t cause serious side effects is used in part 2 of the trial.
  • Part 2 is to test how well the highest safe dose of AZD3965 works in people with diffuse large B-cell lymphoma (DLBCL) and Burkitt lymphoma. You cannot enter this part of the trial if you have another type of lymphoma or cancer. People entering this part of the trial all have the same dose of AZD3965.

Whichever group you are in, you can continue to have the trial treatment for up to 12 months if it is benefiting you.


Who can enter

Your consultant can give you advice on whether this trial might be suitable for you.

Around 64 people are needed for this trial.

You may be able to enter if:

  • You have a solid tumour or lymphoma for part 1 of this trial, or you have Burkitt lymphoma or diffuse large B-cell lymphoma for part 2.
  • Your cancer is not responding to treatment or there is no suitable standard treatment.
  • A sample of your biopsy is available for tests.
  • Your cancer is measurable by the tests used in the trial.
  • You are well enough to take part in this trial.
  • Your blood and other health test results are satisfactory.
  • You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
  • You are 18 or over.

You will not be able to enter if:

  • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
  • You have had other treatments for cancer in the last 4 weeks.
  • Your cancer is in your central nervous system (brain and spinal cord).
  • You have another cancer of any type (part 2 only).
  • You have certain eye problems.
  • You still have significant side effects from your previous treatment.
  • You are taking steroids and the dose has been changed in the last 2 weeks.
  • You can’t swallow tablets or capsules.
  • You have any digestive problems that might make it difficult for you to absorb the trial treatment.
  • You’ve had major surgery in the last 8 weeks.
  • You have any major health problems, including an infection that isn’t under control, a serious allergy or autoimmune disorder, diabetes that isn’t under control, or heart problems.
  • You have had an allogeneic stem cell transplant.
  • You have had extensive radiotherapy in the last 8 weeks.
  • You are taking part in another trial involving treatment.
  • You have HIV, hepatitis C virus or hepatitis B virus.
  • You are pregnant.

Further information

More information about this trial is available at Cancer Research UK