Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391775
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-25
Brief Title:
Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy
Sponsor:
Genmab
Organization:
Genmab
Study Overview
Official Title:
First-In-Human Open-Label Dose Escalation Trial With Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of GEN1055 as Monotherapy and as Combination Therapy in Subjects With Malignant Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this trial is to learn about the antibody GEN1055 when it is used alone and when it is used together with another antibody cancer drug pembrolizumab with or without chemotherapy for treatment of participants with certain types of cancer Participants will receive either GEN1055 alone GEN1055 with pembrolizumab or GEN1055 with pembrolizumab and chemotherapy All participants will receive active drug no one will receive placebo
This trial has 2 parts The purpose of the first part is to find out if GEN1055 is safe and to find out the doses of GEN1055 to use alone and to use with pembrolizumab The purpose of the second part is to give GEN1055 to more participants to see how well the doses of GEN1055 that were selected in the first part work against cancer alone and how well they work with pembrolizumab with or without other chemotherapy
A participant will receive trial treatment up to a maximum of 24 months for pembrolizumab-containing regimens or until
the cancer progresses
there are side effects requiring that treatment be stopped
the participant decides to not participate further in this trial
the doctor believes it is in the participants best interest to stop treatment
Participation in the trial will require visits to the site For the first 12 weeks there will be weekly visits and after that visits will be every 3 weeks At site visits there will be various tests such as blood draws and procedures such as recording of heart activity computed tomography CT scans to monitor whether the treatment is safe and effective The trial duration including screening treatment and follow-up for each participant will be about 39 months
This trial has 2 parts The purpose of the first part is to find out if GEN1055 is safe and to find out the doses of GEN1055 to use alone and to use with pembrolizumab The purpose of the second part is to give GEN1055 to more participants to see how well the doses of GEN1055 that were selected in the first part work against cancer alone and how well they work with pembrolizumab with or without other chemotherapy
A participant will receive trial treatment up to a maximum of 24 months for pembrolizumab-containing regimens or until
the cancer progresses
there are side effects requiring that treatment be stopped
the participant decides to not participate further in this trial
the doctor believes it is in the participants best interest to stop treatment
Participation in the trial will require visits to the site For the first 12 weeks there will be weekly visits and after that visits will be every 3 weeks At site visits there will be various tests such as blood draws and procedures such as recording of heart activity computed tomography CT scans to monitor whether the treatment is safe and effective The trial duration including screening treatment and follow-up for each participant will be about 39 months
Detailed Description:
This is a multi-center trial and will be conducted in two parts dose escalation phase 1a1b and expansion phase 2a
The Dose Escalation part of the trial will evaluate dose-limiting toxicities DLTs to determine the recommended phase 2 dose RP2D and if reached the maximum tolerated dose MTD in participants with locally advanced or metastatic solid tumors
The Expansion part will evaluate safety tolerability mechanism of action MoA immunogenicity pharmacokinetic PK and initial antitumor activity of the selected doses and schedules in selected tumor indications
The Dose Escalation part of the trial will evaluate dose-limiting toxicities DLTs to determine the recommended phase 2 dose RP2D and if reached the maximum tolerated dose MTD in participants with locally advanced or metastatic solid tumors
The Expansion part will evaluate safety tolerability mechanism of action MoA immunogenicity pharmacokinetic PK and initial antitumor activity of the selected doses and schedules in selected tumor indications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-507049-28-00 | CTIS | None | None |