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What is the objective of this trial?

To test a new drug, ADCT-701 (an Antibody-drug conjugate (ADC)), in people with Neuroendocrine Neoplasms (NENs). The eligibility extends to al adults aged 18 and older with NENs. It is listed in the NIH database under clinical trial identify number NCT06041516 (Reference 1 below).

What are Antibody-drug conjugates (ADCs)? 

Antibody-drug conjugates (ADCs) are innovative biopharmaceutical products in which a monoclonal antibody is linked to a small molecule drug with a stable linker. Most of the ADCs developed so far are for treating cancer, but there is enormous potential for using ADCs to treat other diseases. Currently, ten ADCs have been approved by the United States Food and Drug Administration (FDA), and more than 90 ADCs are under worldwide clinical development.

Chemotherapy, with its poor specificity towards tumor cells/tissues, is sometimes associated with a poor therapeutic response and substantial toxicities to normal healthy tissues. Unlike chemotherapy, antibody-drug conjugates target and kill tumor cells without harming the healthy cells, by integrating the antigen specificity of monoclonal antibodies (mAbs) with antibody fragments.  For those who need further detail, see Reference 2 below. 

What is ADCT-701?

  • Pre-clinical studies have shown that Delta-like non-canonical notch ligand 1 (DLK1) is expressed in multiple neuroendocrine neoplasms such as ACC, Small Cell Lung Cancer (a type of Neuroendocrine Carcinoma), neuroblastoma, pheochromocytoma, and paraganglioma.
  • ADCT-701 a humanized antibody directed against DLK1 effectively suppresses tumor growth and improves survival in multiple cancer models which express DLK1.

Trial Summary

This trial is directed to a wide range of NENs but also incudes Adrenocortical carcinoma (ACC). The trial will take place at the NIH Clinical Center in Bethesda, Maryland, USA, and there is no cost for participation.  This is a Phase 1 trial with an estimated start date of 3 June 2024 and a primary completion date of 30th October 2027. The study formally wraps up around 30th October 2029.  They are looking for 70 participants. 

Who is eligible for this trial? Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.  Although there is wide coverage of NEN types on this clinical trial, the exclusion and inlcusion criteria may exclude some of you.  Please make sure you are aware of these criteria.  Click here to read them. 

For more information, please contact Kimberley J. Cooper at (240) 858-7989 or kimberley.cooper@nih.gov – see more at Reference 3. 

This trial is sponsored by the National Cancer Insitutue (NCI) and the Principal Investigator is aydira Del Rivero, M.D.

General Clinical Trials Disclaimer

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact.  If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net

The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan. 

 
 

Disclaimer

I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me. 

Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional.   

Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.

Finally

Whenever I post about a trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product.  Plus, not everyone will be eligible, so always check the exclusion and inclusion criteria in the relevant clinical trials document  Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET

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