ADCT-901 for Solid Tumors

Recruiting at 12 trial locations

Overseen By Contact ADC Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ADC Therapeutics S.A.

Must not be taking: Experimental medications

Disqualifiers: Active infection, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objectives of this study are to identify the recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD), and to characterize the safety and the tolerability of ADCT-901.

Eligibility Criteria

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.

Inclusion Criteria

My current treatment isn't working or causes severe side effects.

My cancer has spread to my bones, but it can be measured by scans.

I have prostate cancer with bone metastases and a PSA level of 2.0 ng/mL or higher.

Exclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of ADCT-901 as monotherapy until disease progression, adverse event, or other discontinuation criteria

Variable

Dose Expansion

Participants receive ADCT-901 monotherapy at the dose identified as the RP2D/MTD in Part 1 until disease progression, adverse event, or other discontinuation criteria

Variable

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 2.5 years

Treatment Details

Interventions

• ADCT-901

Trial Overview 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.

Participant Groups

Group I: Part 2: Dose Expansion Experimental Treatment 1 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 Escalation Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

ADC Therapeutics S.A.

Lead Sponsor

Trials

32

Recruited

2,700+