Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573294
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Trial to Assess the Safety and Antitumor Activity of GEN1057 in Malignant Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A First-In-Human Open-Label Dose Escalation Trial to Evaluate the Safety and Antitumor Activity of GEN1057 in Subjects With Malignant Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 doses 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
The dose escalation will evaluate different dose levels by assessing safety tolerability and early efficacy signals to determine the expansion doses 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None