In short
ADCT-901 is an investigational antibody-drug conjugate (ADC) studied in a completed Phase 1 clinical trial involving 132 participants with selected advanced solid tumors. The trial evaluated the safety, tolerability, pharmacokinetics, and antitumor activity of ADCT-901 given as monotherapy by intravenous administration. Its main goals were to identify the recommended Phase 2 dose and/or maximum tolerated dose.
Key points
- ADCT-901 is an investigational antibody-drug conjugate studied in advanced solid tumors.
- The trial was a Phase 1, open-label, dose-escalation and dose-expansion study.
- 132 participants were enrolled in the trial.
- The study status is Completed.
- The primary outcomes included adverse events, dose-limiting toxicities, and laboratory safety measures.
What is ADCT-901?
ADCT-901 is an investigational antibody-drug conjugate, a type of targeted cancer therapy that links an antibody to a cell-killing drug. It has not been authorised as a medicine and is being studied in clinical trials. In the registry records, the therapeutic area is neoplasms, meaning cancers.
How does ADCT-901 work?
As an antibody-drug conjugate, ADCT-901 is designed to deliver a toxic payload directly to cancer cells. The antibody part is intended to recognise and bind to a target on the surface of cancer cells, after which the attached drug can enter the cell and act against it. The trial was designed to characterise the safety, tolerability, and antitumor activity of ADCT-901.
Which conditions is it studied for?
- Advanced solid tumors — cancers that have spread locally or to other parts of the body and are not considered curable by surgery or radiation alone. The trial enrolled patients with selected types of these tumors.
How is ADCT-901 given?
ADCT-901 was given by intravenous administration, meaning it was injected directly into a vein. The trial used a dose of 22 mg in the reported intervention.
What do the clinical trials show?
One completed Phase 1 trial investigated ADCT-901 in 132 participants with selected advanced solid tumors. The study was open-label, meaning both the participants and the researchers knew which treatment was being given. It had a dose-escalation and a dose-expansion part. The main purpose was to identify the recommended Phase 2 dose and/or the maximum tolerated dose, and to characterise the safety and tolerability of ADCT-901 as monotherapy.
The primary outcomes measured in the trial included the frequency and severity of adverse events and serious adverse events, the incidence of dose-limiting toxicities during dose escalation, changes from baseline in safety laboratory values, vital signs, Eastern Cooperative Oncology Group performance status, and 12-lead electrocardiograms, as well as the frequency of dose interruptions and dose reductions.
What side effects are known?
No side effects are described in the provided sources.