Summary
This clinical trial aims to learn more about a new drug called MT‑304 by studying how safe it is, how the body processes it, how it affects the cancer, and whether it shows early signs of benefit in adults with advanced solid cancers that have a protein called HER2.
The study is recruiting adults with metastatic or locally advanced epithelial cancers that express HER2, including:
- urothelial cancer
- endometrial cancer
- ovarian epithelial cancer
- breast cancer
- stomach (gastric) cancer
- oesophageal cancer
- non-small cell lung cancer
- bowel (colorectal) cancer
- biliary cancer (including gallbladder cancer and extrahepatic cholangiocarcinoma).
However, participants with other tumour types expressing HER2 may be considered following a discussion with the Medical Monitor.
The main questions the trial aims to answer are:
- What is the safety profile of MT-304 when administered alone or with nivolumab immunotherapy?
- What is the recommended Phase 2 dose (RP2D) of MT-304?
The study consists of two treatment modules:
- Module 1 (Monotherapy): Participants receive MT-304 every 14 days for 28-day cycles, with dosing adjustments based on clinical benefit and safety evaluations.
- Module 2 (Combination therapy): Participants receive MT-304 in combination with nivolumab, given every 14 days and 28 days, respectively, also allowing for dosing adjustments.
Regular assessments, including vital signs and laboratory tests, will monitor safety and efficacy throughout the trial, with follow-up visits for up to 2 years post-treatment.