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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

Must not have

Active diarrhea ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or a medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease).

Active or clinically significant ocular disease including ocular surface disease at baseline. An ocular evaluation is to be confirmed by an ophthalmologist at screening. Participants with any prior episode of cicatricial conjunctivitis (as evaluated by the ophthalmologist) are ineligible.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2.5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My cancer is one of the specified types and is advanced or has spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe or chronic diarrhea.

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I do not have any significant eye diseases or history of severe conjunctivitis.

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I have fluid buildup needing drainage or causing breathing problems.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2.5 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

Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 4Eligibility criteria met