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Monoclonal Antibodies
ADCT-901 for Solid Tumors
Phase 1
Waitlist Available
Research Sponsored by ADC Therapeutics S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologic diagnosis of selected solid tumor malignancy that is locally advanced or metastatic at time of Screening: cholangiocarcinoma, ovarian/fallopian tube cancers, prostate cancer, renal cell carcinoma, and triple negative breast cancer (TNBC).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2.5 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see what doses are safe and effective, and to learn more about any side effects.
Who is the study for?
This trial is for adults with certain advanced solid tumors (like cholangiocarcinoma, ovarian, prostate cancer, renal cell carcinoma, and TNBC) that are measurable and have not responded to or can't tolerate current treatments. Participants should not have active severe diarrhea or eye diseases, recent serious infections requiring IV treatment, symptomatic brain metastases or leptomeningeal disease.Check my eligibility
What is being tested?
The study tests ADCT-901's safety and tolerability to find the right dose for phase 2 trials. It aims to see how participants' bodies handle the drug (pharmacokinetics) and its effectiveness against selected solid tumors at different doses.See study design
What are the potential side effects?
While specific side effects of ADCT-901 aren't listed here, common ones in such trials include reactions at the injection site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding tendencies. Organ-specific toxicity might also occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is one of the specified types and is advanced or has spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Who Experience a Dose Interruption
Number of Participants Who Experience a Dose Limiting Toxicity (DLT) During the Dose-Escalation Phase
Number of Participants Who Experience a Dose Reduction
+1 moreSecondary outcome measures
Accumulation Index (AI) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Apparent Clearance (CL) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
Apparent Terminal Elimination Half-Life (Thalf) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part 2: Dose ExpansionExperimental Treatment1 Intervention
In Part 2 (dose expansion), participants will receive ADCT-901 monotherapy at the dose identified as the RP2D/MTD in Part 1 (dose escalation).
Participants will be split into two groups:
Group 1: An indication for which ADCT-901 showed in Part 1 to have preliminary activity.
Group 2: A group of participants with Part 1 indications, except for the one selected in Group 1 of Part 2. No more than 30% of participants with the same indication are allowed in this basket group.
Participants can receive ADCT-901 until disease progression, AE, or other discontinuation criteria, whichever occurs first.
Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention
In Part 1 (dose escalation) participants with selected advanced solid tumors will receive escalating doses of ADCT-901 as monotherapy. Participants can receive ADCT-901 until disease progression, adverse event (AE), or other discontinuation criteria, whichever occurs first.
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Who is running the clinical trial?
ADC Therapeutics S.A.Lead Sponsor
28 Previous Clinical Trials
2,101 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My current treatment isn't working or causes severe side effects.I have severe or chronic diarrhea.I have mild eye conditions but not an active eye disease.I do not have any significant eye diseases or history of severe conjunctivitis.I have brain metastases but have been treated and stable for over 4 weeks.I have tested negative for COVID-19 within 5 days before starting the study treatment.My cancer has spread to my bones, but it can be measured by scans.You have taken any other experimental medication within 14 days before starting the study drug.I have prostate cancer with bone metastases and a PSA level of 2.0 ng/mL or higher.My prostate cancer includes specific types like neuroendocrine or small cell.I have not had a serious infection requiring IV treatment in the last 4 weeks.My cancer is one of the specified types and is advanced or has spread.I have fluid buildup needing drainage or causing breathing problems.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Dose Escalation
- Group 2: Part 2: Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximal number of participants being accepted into this clinical experiment?
"To conduct the trial, 76 individuals must fulfill all eligibility criteria. These participants can come from two major locations: Northwestern University in Chicago, Illinois and UHCMC in Cleveland, Ohio."
Answered by AI
Are there multiple sites throughout the US where this clinical trial is occurring?
"Currently, this clinical trial is enrolling patients in 7 separate sites. These include Chicago, Cleveland and Oklahoma City as well as 4 other locations. To limit the burden of travel during participation, it's advisable to choose a site closest to your area."
Answered by AI
What safety measures has ADCT-901 been evaluated for?
"There is only limited clinical data to support the safety and efficacy of ADCT-901, thus it was given a score of 1."
Answered by AI
Is there still an opportunity to join this experiment?
"According to the clinicaltrials.gov database, this medical trial is actively recruiting patients. Originally posted on September 9th 2021 and last updated on July 18th 2022, it has been live for nearly a year now."
Answered by AI
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