Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT03700294
Brief Summary:
This study evaluates the safety, tolerance, pharmacokinetics (PK), and antitumor activity of ADCT-601 in patients with advanced solid tumors.
Detailed Description:
This is a Phase 1 open-label, multicenter single-arm study with a dose-escalation phase (Part 1) followed by a dose-expansion phase (Part 2). The study will enroll approximately 75 patients. A standard 3+3 dose-escalation design will be used for Part 1 in order to determine the MTD and/or recommended dose for expansion (RDE).
Part 2 will consist of 3 cohorts from one or more selected tumor types. Each cohort will enroll 15 patients.
The study will include a Screening Period (of up to 28 days), a Treatment Period (cycles of 3-6 weeks), and a Follow-up Period (visits approximately every 12 weeks for up to 2 years after treatment discontinuation).
Study:
NCT03700294
Study Brief:
Protocol Section:
NCT03700294