Trial summary
The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM001 for patients with the advanced solid tumors. DM001 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors.
Participants will have up to 17 visits during the study. There will be up to a 4-week Screening Period followed by a treatment period that will be divided into 3-week cycles/ Participants will have 5 study visits during Cycle 1, 3 visits during Cycles 2 and 3, and 1 visit during subsequent cycles. Participants will have an End of Treatment visit 21 days (+ 7 days) after last dose of study drug and then a follow-up visit 30 days (± 7 days) after the End of Treatment visit.
DM001, a bispecific ADC developed using fully human antibodies with a common light chain, which targets TROP2 and EGFR.
DM001 is sterile yellowish-green lyophilized powder for IV infusion.
Subjects with solid malignant tumors will be treated with DM001 on Day 1 once Q3W (dose adjustments may be required depending on the safety profile and PK data of each dose).
Trial details
Short title
DM001001
Diagnosis
Advanced solid tumours
Type of treatment
Medical Oncology
Phase
I
Locations
Who can participate
Clinical trials can have restrictive criteria of who can and can’t participate, talk to your healthcare provider if you are interested in this clinical trial.