ADCT-701 for Rare Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new drug, ADCT-701, for treating rare neuroendocrine neoplasms (NENs), which are cancers that can occur in areas such as the gastrointestinal tract and lungs. These cancers often recur and have low survival rates, making the search for better treatments crucial. The trial seeks adults diagnosed with NENs who have not found success with other treatments. Participants will receive the drug through an IV and return to the clinic for regular check-ups and tests. This trial may suit those with recurring symptoms who have not responded well to standard treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot have had major surgery, chemotherapy, hormonal therapy, immunotherapy, or radiation therapy within 4 weeks before starting the trial. Also, you should not take any herbal supplements within 14 days before starting the trial.
Is there any evidence suggesting that ADCT-701 is likely to be safe for humans?
Research shows that ADCT-701 remains in the early testing stages, but some information about its safety is available. In animal studies, the drug controlled tumor growth without causing severe side effects. This suggests potential safety for humans, though further testing is necessary for confirmation.
The current study, in its first phase, primarily focuses on assessing the drug's safety in humans. Researchers closely monitor how participants handle the drug and any side effects they experience.
While limited data exists on human safety, this phase aims to determine if ADCT-701 is well-tolerated. Participants will be carefully monitored to ensure their safety throughout the trial.12345Why do researchers think this study treatment might be promising?
ADCT-701 is unique because it uses an antibody-drug conjugate (ADC) approach to target rare cancers. Most treatments for these cancers involve chemotherapy or radiation, which can affect both cancerous and healthy cells. ADCT-701, however, combines an antibody that specifically seeks out cancer cells with a powerful drug that only activates when inside these cells. This precision aims to reduce side effects and improve effectiveness, making researchers excited about its potential to offer a more targeted and efficient treatment option.
What evidence suggests that ADCT-701 might be an effective treatment for neuroendocrine neoplasms?
Research shows that ADCT-701, which participants in this trial will receive, targets DLK1, a protein often present in many neuroendocrine tumors. Studies have demonstrated that ADCT-701 successfully slowed tumor growth and increased survival rates in various cancer models with DLK1. Early lab tests showed promising results against tumors using patient-derived organoids (small, simple versions of organs grown in the lab) and cell samples. These findings suggest that ADCT-701 could effectively treat neuroendocrine tumors, especially those with high levels of DLK1.12356
Who Is on the Research Team?
Jaydira Del Rivero, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
Adults over 18 with neuroendocrine tumors or adrenocortical carcinoma, who've tried standard treatments without success. They must have measurable disease, be able to perform daily activities to a certain extent, and agree to use contraception. Excluded are those with recent other cancer treatments, uncontrolled illnesses, certain heart conditions, active infections or allergies related to the study drug.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ADCT-701 through IV infusion on the first day of 21-day treatment cycles. They will visit the clinic 10 times during the first two cycles and 2 times during each subsequent cycle.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits every 9 weeks including imaging scans.
What Are the Treatments Tested in This Trial?
Interventions
- ADCT-701
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor