This phase 1/2 trial is examining the effectiveness and safety of KY1044 alone and in combination with atezolizumab (Tecentriq) for patients with advanced cancers who are not suitable for any other treatment or have failed all other treatment options. The main outcomes to be measured will be the occurrence and severity of side effects and response to treatment.
The details
A treatment option for patients with advanced cancers is with atezolizumab. Atezolizumab is an immunotherapy approved for the treatment of certain advanced cancers that cannot be surgically removed. It is a type of monoclonal antibody (laboratory-produced molecules engineered to stimulate the immune system to destroy cancer cells).
It is not known if atezolizumab added to KY1044 is more effective than KY1044 alone in patients with advanced cancers. KY1044 is also a type of monoclonal antibody.
This study is being done to investigate the use of atezolizumab in combination with KY1044 vs KY1044 alone for patients with advanced cancers who are not suitable for any other treatment or have failed all other treatment options. The main outcomes will be the occurrence of side effects and treatment response after 24 months.
Who are they looking for?
412 participants with selected advanced cancers including melanoma will be recruited. Patients can have had prior treatment with atezolizumab but must not have had serious side effects, and should have a life expectancy higher than 12 weeks. Patients should also have a biopsy of their tumor.
Patients cannot participate if they have brain metastases (tumors), a previous or current autoimmune condition, another primary cancer, a history of tuberculosis, hepatitis or HIV or use of live vaccines in the previous 4 weeks. Female patients who are pregnant or breastfeeding cannot participate. Patients will be excluded if they have abnormal blood cell counts, kidney and liver function tests, heart disease or if they had radiotherapy less than 2 weeks before the trial.
How will it work
There will be 2 phases to the trial. Both phases will have two groups. Group 1 will receive KY1044 alone and group 2 will receiveKY1044 withatezolizumab. Patients will be followed up in 24 months to measure the side effects and response to treatment.
