PROCLAIM-CX-072: a phase 1/2 trial to find the best dose and test the effectiveness of a newer drug, CX-072, in people with solid tumours or lymphoma

This trial is testing targeted drugs in people whose lymphoma got worse after standard treatment.

Note: This trial is recruiting people with other types of cancer also. This information is only for people with lymphoma.


Purpose of trial

The aim of this trial is to test whether CX-072 on its own or in combination with other treatments is safe and effective for people with advanced-stage (widespread) solid tumours or lymphomas that got worse despite standard treatment. The trial aims to find out:

  • the best dose of CX-072 alone and in combination with ipilimumab or vemurafenib
  • the side effects of CX-072 alone or with other treatments
  • if CX-072 alone or in combination with other treatments can reduce the cancer.

Treatments

CX-072 is an immune checkpoint inhibitor – it works by helping the immune system recognise and attack the cancer cells.

Ipilimumab and vemurafenib are newer drugs already used to treat advanced melanoma. They are in clinical trials for other types of cancer.

Everyone in this trial has CX-072. Different doses and schedules of treatment are being tested. Some people in this trial have ipilimumab or vemurafenib in combination with CX-072. You cannot choose which treatment you have. You are told which treatment you are having and you are given information about it.

CX-072 and ipilimumab are given intravenously (through a drip into a vein).Vemurafenib is taken as tablets.


Who can enter

Your consultant can advise you whether you might be suitable for this trial. Note: this information is for people with lymphoma. Different factors may apply to people with other types of cancer.

150 people are needed for this trial.

You may be able to enter if:

  • You have advanced-stage lymphoma that has got worse after standard treatment.
  • A sample of a biopsy of your lymphoma is available or you are willing to have a fresh biopsy taken.
  • You are 18 or over.

You will not be able to enter if:

  • You have been treated with chimeric antigen receptor (CAR) T-cells before.
  • You have had a serious bad reaction to human antibody therapy or any similar drugs before.
  • You have or have had uveal, mucosal or ocular melanoma (melanoma in your eye or in the moist linings in your body).
  • You have or have had an autoimmune disease (where your immune system attacks your own body), for example, inflammatory bowel disease, rheumatoid arthritis or type 1 diabetes, among others.
  • You are taking steroids (except at a low dose) or medication that suppresses your immune system.
  • You have had an organ transplant or a stem cell transplant.
  • You have had another anti-cancer treatment or any experimental treatment in the last 30 days.
  • You have had major surgery (under general anaesthetic) in the last 3 months or minor surgery (except biopsies under local anaesthetic) in the last 14 days.

Further information

More information about this trial is available at clinicaltrials.gov/ct2/show/study/NCT03013491. You or your doctor can also contact the trial team at clinicaltrials@cytomx.com.