Summary
This study will be conducted in two parts to assess the safety of AT-0174, how the treatment interacts within the body, and to determine the maximum safe dose that may be administered to patients with advanced solid cancers.
Who is it for?
You may be eligible for this study if you are aged 18 years or older, and have been diagnosed with an unresectable, locally advanced or metastatic solid cancer. This include but is not limited to:
- non-small cell lung cancer
- small cell lung cancer
- triple-negative breast cancer
- malignant melanoma
- stomach, gastro-oesophageal junction or oesophageal cancer
- squamous cell cancer of the opesophagus
- colorectal cancer
- pancreatic cancer
- epithelial ovarian cancer (fallopian, ovarian, primary peritoneal cancer)
- endometrial cancer
- thyroid cancer (non-medullary)
- moderate-high grade astrocytoma (brain cancer).
The researchers may decide to recruit people with other solid cancers, speak to your clinician or a recruiting trial unit for more information.
Study details
This study will be conducted across two parts.
In the first sub-study (Part 1), participants will be allocated to the next available dosing cohort.
- Cohort 1: Take a daily oral capsule of AT-0174 for 7 days, followed by 3 weeks of no treatment.
- Cohort 2: Take a daily oral capsule of AT-0174 for 14 days, followed by 2 weeks of no treatment.
- Cohort 3: Take a daily oral capsule of AT-0174 for 28 days with no breaks.
In the second sub-study (Part 2), participants will be allocated to the next available dosing cohort. This sub-study will ask all participants to take a daily oral capsule of AT-0174 for 28 days with no breaks. The dose of AT-0174 may increase in amount or frequency (e.g. twice per day) with each successive cohort in Part 2, based on careful assessment of the safety and tolerability of each dose.
All participants will have their vital signs (heart rate, blood pressure, temperature, etc) checked and will provide blood and urine samples for testing. In addition, participants will have their cancer assessed using CT, MRI or CT/PET scans during the study. Participants may continue taking AT-0174 for as long as they and their doctor agree.
It is hoped this research will determine the maximum dose of AT-0174 that can be administered safely without causing severe reactions. Once the safest maximum dose of AT-0174 has been determined, a larger trial investigating the efficacy of AT-0174 as a treatment for a greater number of cancer patients may proceed.