TD001 for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is studying a new treatment called TD001, a potential drug for prostate cancer that has spread and resists standard hormone therapy. The researchers aim to determine TD001's safety and effectiveness against the cancer. Participants will receive varying doses to identify the safest and most effective amount. This trial targets men whose prostate cancer shows growth despite treatments and who have a specific protein called PSMA. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding how it works in people.
Is there any evidence suggesting that TD001 is likely to be safe for humans?
Research has shown that TD001, a new treatment for prostate cancer, is producing positive results in early studies. Researchers are testing this treatment at different doses, and patients have generally tolerated it well, with few serious side effects reported.
It is important to understand that this treatment remains in the early stages of testing. Researchers are primarily focused on assessing its safety and how the body processes it. They also aim to determine if it can help stop tumor growth. So far, studies suggest that TD001 is safe enough to continue testing, but like all new treatments, it may carry risks.
Prospective trial participants should know that researchers will closely monitor their health. The goal is to ensure the treatment remains as safe as possible while they learn more about its effects.12345Why do researchers think this study treatment might be promising?
Unlike the standard prostate cancer treatments like hormone therapy, surgery, or radiation, TD001 is unique because it is being explored for its new mechanism of action. Researchers are excited about TD001 because it works by targeting specific cellular pathways involved in cancer growth, potentially offering a more precise approach to treatment. This could mean fewer side effects and improved effectiveness compared to conventional options. Plus, the dose escalation and recommended Phase 2 dose strategies aim to optimize its use, making TD001 a promising candidate in the fight against prostate cancer.
What evidence suggests that TD001 might be an effective treatment for prostate cancer?
Research has shown that TD001 may help treat prostate cancer by targeting a protein called PSMA, which is abundant on prostate cancer cells. Early studies in mice demonstrated that TD001 can significantly slow tumor growth, with stronger effects at higher doses. Although these results come from animal studies, they suggest that TD001 might also be effective in humans with prostate cancer that has high levels of PSMA. In this trial, participants will receive TD001 in either a dose escalation arm or an RP2D dose expansion arm to evaluate its effectiveness and safety at different dosing levels.12678
Are You a Good Fit for This Trial?
Men with metastatic prostate cancer that resists castration treatments and shows PSMA expression can join this trial. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be excluded for safety reasons or if they have other complicating conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Sequential groups of participants receive TD001 at escalating doses to determine the maximum tolerated dose
RP2D Dose Expansion
Participants receive TD001 at the recommended Phase 2 doses (RP2Ds) to evaluate safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TD001
Find a Clinic Near You
Who Is Running the Clinical Trial?
T.O.A.D. Oncology SA
Lead Sponsor