This phase 1/2 trial is examining the effectiveness of treatment with GB1275 alone or in combination with immunotherapy in patients with solid tumors such as triple-negative breast cancer. The main outcome to be measured will be dose toxicity and tumor response to the treatment. This study is being conducted in Tennessee and Texas, US.
The details
The standard treatment for advanced cancers used to be surgery and chemotherapy. Chemotherapy is a cancer treatment that consists of a combination of agents that kill cancer cells. However, this treatment had only a limited effectiveness in advanced cases. The combination of chemotherapy with immunotherapy has been shown to improve the effectiveness of cancer treatment. Immunotherapy such as GB1275 helps the immune system to attack and kill cancer cells.
This trial is examining the safety and effectiveness of treatment with GB1275 alone or in combination with immunotherapy in patients with solid tumors such as triple-negative breast cancer. The main outcome to be measured will be dose toxicity and tumor response to the treatment.
Who are they looking for?
This trial is recruiting 202 patients with solid tumors including triple-negative breast cancer. Female patients must use effective birth control during the study.
Patients must not have history of another cancer within 2 years prior to this trial. They also must not have a history of HIV, hepatitis B or C and gastrointestinal disease. Women must not be pregnant or breastfeeding.
How will it work
This study will be divided into 2 phases. In phase 1, participants will be assigned to receive increasing doses of GB1275 alone or with either pembrolizumab (Keytruda; an immunotherapy) or standard care. Patients who will go to phase 2 will receive GB1275 with pembrolizumab or standard of care.
The main outcomes to be measured will be dose toxicity and tumor response to the treatment. Patients will be followed up for up to 2 years.
