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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT06573294
Brief Summary:
The purpose of this trial is to study the antibody GEN1057 when used as a single agent for the treatment of certain types of cancer.
Trial details include:
* The trial duration will be up to approximately 11 months.
* The treatment duration will be up to approximately 4 months (the duration of treatment may vary for each participant) and the follow-up duration will be approximately 6 months.
Participation in the trial will require visits to the site. All participants will receive active drug; no one will be given placebo.
Detailed Description:
The trial is a first-in-human (FIH) open-label, multicenter, multinational safety trial.
The dose escalation will evaluate different dose levels by assessing safety, tolerability, and early efficacy signals to determine the expansion dose(s) of GEN1057 as monotherapy, as well as characterizing the pharmacokinetic (PK) profile and immunogenicity in participants with malignant solid tumors who have metastatic or advanced disease.
Study:
NCT06573294
Study Brief:
Protocol Section:
NCT06573294