ADCE-D01 for Soft Tissue Sarcoma
(ADCElerate1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of a new treatment called ADCE-D01 for individuals with soft tissue sarcoma, a type of cancer that has spread or cannot be surgically removed. Researchers aim to determine if ADCE-D01 can help manage the disease after patients have tried one or two other treatments. The trial seeks participants diagnosed with soft tissue sarcoma that current methods cannot cure. As a Phase 1 trial, this research focuses on understanding how ADCE-D01 works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have had any systemic anticancer therapy, including investigational agents, within 4 weeks before starting the study treatment.
Is there any evidence suggesting that ADCE-D01 is likely to be safe for humans?
Research has shown that ADCE-D01 is generally safe and well-tolerated. Studies have found no harmful effects on the specific body parts the treatment aims to protect. The FDA has granted ADCE-D01 a fast track designation, indicating potential benefits in its safety and effectiveness for treating soft tissue sarcoma. Overall, early results suggest patients might handle this treatment well.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatment options for soft tissue sarcoma, which often involve chemotherapy drugs like doxorubicin or ifosfamide, ADCE-D01 is unique because it targets the cancer cells in a new way. Researchers are excited about this treatment because it introduces a novel mechanism of action, potentially offering a more precise attack on tumor cells while sparing healthy tissue. This could mean fewer side effects and improved outcomes for patients. Additionally, ADCE-D01 has shown promise in early phases of testing, sparking hope for a more effective approach to managing this challenging condition.
What evidence suggests that ADCE-D01 might be an effective treatment for soft tissue sarcoma?
Research shows that ADCE-D01, the treatment under study in this trial, targets a specific protein called uPARAP, found in soft tissue sarcomas. This targeting allows the treatment to deliver medication directly to cancer cells. Early studies have shown promising results. In animal studies, ADCE-D01 proved effective and well-tolerated for treating soft tissue sarcoma. The FDA has fast-tracked this treatment, indicating it could meet a critical need for better options. While more research is needed, these findings offer hope for its potential effectiveness in humans.12567
Are You a Good Fit for This Trial?
This trial is for adults over 18 with soft tissue sarcoma that can't be removed by surgery and has spread. They should have tried at least one, but no more than two, previous cancer treatments. Participants need to be fairly active (ECOG status of 0 or 1) and expected to live at least three months. Women must not be pregnant or breastfeeding and either not able to become pregnant or follow strict birth control guidelines. Men must use barrier contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation and Expansion
Participants receive ADCE-D01 to evaluate safety, pharmacokinetics, and antitumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ADCE-D01
Find a Clinic Near You
Who Is Running the Clinical Trial?
Adcendo ApS
Lead Sponsor