DM002 for Cancer
Trial Summary
What is the purpose of this trial?
The goal of study： The study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion. In Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There will be up to six or more dose levels of study drug tested (called cohorts). Which dose you receive will depend on how many participants have taken part in the study before you. The purpose of Part 1 of the study is to evaluate the safety of the study drug at different dose levels, to understand what your body does to the study drug, and to find the best dose of study drug in people who have advanced solid tumor cancers. In Part 2, participants will receive the best dose level that was determined in Part 1 of the study. The purpose of Part 2 of the study is to evaluate the safety of the study drug at the dose level determined in Part 1, to understand what your body does to the study drug, and to see how your cancer responds to the study drug. Participants will: Participants will have 17 or more visits to the study centre. This study has a screening phase of up to 28 days , and a treatment phase with cycles of 21 days each. Participants will also have an End of Treatment (EOT) visit 21 days after the final study drug treatment, and a Follow-up visit 30 days after the EOT visit . Participants will be contacted by telephone every 3 months after the Follow-up visit to check on the wellbeing and record any new anticancer therapy they may have started.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had anticancer therapy within 28 days before the first study dose, and you should avoid drugs or food that strongly affect certain liver enzymes (CYP3A4/5) within 2 weeks before starting the trial.
What data supports the effectiveness of the drug DM002 for cancer?
What safety data exists for DM002 (dimethyl fumarate) in humans?
Dimethyl fumarate (DMF) has been used safely for about 9 years in people with multiple sclerosis, but it can cause some side effects, mainly affecting the stomach and intestines. In a study with cancer patients, it was tested with other treatments and its safety was evaluated, but specific side effects in this group were not detailed.678910
How does the drug DM002 differ from other cancer treatments?
DM002 is unique because it targets the interaction between two proteins, MDM2 and p53, which is crucial in many cancers. By inhibiting this interaction, DM002 can potentially reactivate p53's tumor-suppressing abilities, offering a novel approach compared to traditional treatments that do not specifically target this pathway.1112131415
Eligibility Criteria
This trial is for adults over 18 with advanced solid tumors who can consent to treatment, have a life expectancy of at least 3 months, and are in relatively good physical condition (ECOG status of 0-2). They must have adequate blood cell counts and kidney function. People cannot join if they've had certain treatments within two weeks before the study starts.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Part 1: Dose Escalation
Participants receive escalating doses of DM002 to evaluate safety and determine the maximum tolerated dose
Treatment - Part 2: Dose Expansion
Participants receive the best dose level determined in Part 1 to evaluate safety and cancer response
End of Treatment (EOT)
Participants have an EOT visit 21 days after the final study drug treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- DM002
Find a Clinic Near You
Who Is Running the Clinical Trial?
Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
Lead Sponsor