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Monoclonal Antibodies

ADCT-701 for Rare Cancers

Phase 1
Recruiting
Led By Jaydira Del Rivero, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status <= 2
Breastfeeding participants must be willing to discontinue breastfeeding
Must not have
Major surgery, prior treatment with chemotherapy, hormonal therapy, immunotherapy, treatment with an investigational agent, and/or radiation therapy within 4 weeks or 5 halflives, whichever is shorter, prior to treatment initiation
Participants who have wound dehiscence from prior surgeries
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug for adults with rare cancers in the digestive system, pancreas, lungs, and other parts of the body. Participants will have tests and receive the drug every 21 days for up to 2 years, with follow-up for up to 5 years.

Who is the study for?
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.
What is being tested?
The trial is testing ADCT-701 in patients with rare cancers of various glands. It involves receiving the drug through an IV on day one of each 21-day cycle for up to two years. Participants will undergo regular clinic visits that include physical exams and various tests like imaging scans and blood draws.
What are the potential side effects?
Specific side effects of ADCT-701 aren't listed but may include typical reactions from similar cancer drugs such as fatigue, nausea, allergic reactions, blood count changes leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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I am breastfeeding but willing to stop for the trial.
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I have been diagnosed with a neuroendocrine tumor or adrenal cancer.
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I am 18 years old or older.
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My cancer has spread beyond its original location.
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I've tried and didn't respond or couldn't tolerate the usual treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had major surgery or cancer treatment in the last 4 weeks.
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My surgical wound reopened after a previous operation.
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I am currently on antibiotics for an infection.
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I am on blood thinners with a target INR > 2.
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I have a long QT syndrome or my heart's electrical cycle is longer than normal.
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I have not received a live vaccine in the last 30 days.
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I have another type of cancer that is currently active.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the maximum tolerated dose (MTD) of ADCT-701
Secondary study objectives
Immunogenicity of ADCT-701
PK profile of ADCT-701
Preliminary anti-tumor activity of ADCT-701
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1/Arm1Experimental Treatment1 Intervention
ADCT-701 given as an IV infusion

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,917 Previous Clinical Trials
41,014,397 Total Patients Enrolled
Jaydira Del Rivero, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
1,405 Total Patients Enrolled
~47 spots leftby Oct 2027
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