Clinical Trials

Date: 2017-05-19

Type of information: Treatment of the first patient

phase: 1

Announcement: treatment of the first patient

Company: ADC Therapeutics (Switzerland)

Product: ADCT-502

Action mechanism:

• antibody drug conjugate.  ADCT-502 is an investigational antibody drug conjugate (ADC) composed of the humanized monoclonal antibody trastuzumab directed against the human epidermal growth factor receptor 2 (HER2). The antibody is site-specifically conjugated to the PBD-based linker-drug tesirine. Once bound to the HER2 receptor on the cell surface, ADCT-502 is internalized into the cell where enzymes release the PBD-based warhead. HER2 is a well-established, clinically validated target expressed in a wide variety of solid tumors, including breast, gastric, esophageal, bladder and lung cancer.

Disease: solid tumors with HER2 expression

Therapeutic area: Cancer - Oncology

Country: USA

Trial details: This study evaluates ADCT-502 in patients with Advanced Solid Tumors with HER2 Expression. Patients will participate in a dose-escalation phase (Part 1) and dose expansion (Part 2). In Part 2, patients will receive the dose level identified in Part 1. (NCT03125200)

Latest news: • On May 19, 2017,  ADC Therapeutics announced that the first patient has been dosed in a Phase I clinical trial to evaluate its antibody drug conjugate (ADC) ADCT-502 in patients with advanced solid tumors with HER2 expression. The two stage, open-label Phase Ia / Ib clinical trial will evaluate the safety, tolerability, pharmacokinetics and efficacy of ADCT-502 in patients with advanced solid tumors with HER2 expression. The first stage (Phase Ia) is a dose escalation phase which will recruit patients at leading clinical centres across the US and EU, and will seek to determine the recommended dose of ADCT-502. The second consecutive stage (Phase Ib), has the objective to confirm the safety and efficacy profile for ADCT-502 in expanded patient cohorts in multiple potential cancer indications. Given the substantial prevalence of HER2 expression in a range of cancers, ADCT-502 will be evaluated in patients with non-small cell lung cancer (NSCLC), bladder, biliary tract, and ovarian cancer, for which HER2 targeted therapies are not yet approved.

Is general: Yes