Ignite Creation Date:
2024-05-06 @ 2:33 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04358458
Status:
TERMINATED
Last Update Posted:
2023-09-21
First Post:
2020-04-01
Brief Title:
First-in-Human FIH Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
Sponsor:
Genmab
Organization:
Genmab
Study Overview
Official Title:
Safety and Efficacy of GEN3009 DuoHexaBody-CD37 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A First-in-Human Open-label Phase 12a Dose Escalation Trial With Dose Expansion Cohorts
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to strategic evaluation of GEN3009 within context of Genmabs portfolio decision not based on any safety or regulatory concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The drug that will be investigated in the study is an antibody GEN3009 Since this is the first study of GEN3009 in humans the main purpose is to evaluate safety Besides safety the study will determine the recommended GEN3009 dose to be tested in a larger group of patients and assess preliminary clinical activity of GEN3009 GEN3009 will be studied in a broad group of cancer patients having different kinds of lymphomas All patients will get GEN3009 either as a single treatment monotherapy or in combination with another antibody-candidate for treatment of cancer in the blood The study consists of two parts Part 1 tests increasing doses of GEN3009 escalation followed by Part 2 which tests the recommended GEN3009 dose from Part 1 expansion
Detailed Description:
This trial will be conducted in 2 parts Part 1 Dose Escalation and Part 2 Dose Expansion All subjects in Part 1 will receive GEN3009 administered at various dose levels in 28-day cycles Dose Limiting Toxicity DLT will be assessed during the first treatment cycle of Part 1 and the Maximum Tolerated Dose MTD andor Recommended phase 2 dose RP2D will be identified
Subjects in Part 2 will be treated with the Part 1-defined RP2D of GEN3009 Some subjects will receive GEN3009 in combination of a fixed dose of another antibody-candidate Subjects in Part 2 are assigned either to one of 3 groups Part 2 Monotherapy hereafter referred to as Part 2A Part 2 Combination Safety Run-in Part2B or Part 2 Combination Part2C
Various types of B-cell NHLs are studied including diffuse large B cell lymphoma DLBCL high-grade B cell lymphoma HGBCL mantle cell lymphoma MCL primary mediastinal large B-cell lymphoma PMBCL follicular lymphoma FL marginal zone lymphoma MZL and chronic lymphocytic leukemiasmall lymphocytic lymphoma CLLSLL
Subjects in Part 2 will be treated with the Part 1-defined RP2D of GEN3009 Some subjects will receive GEN3009 in combination of a fixed dose of another antibody-candidate Subjects in Part 2 are assigned either to one of 3 groups Part 2 Monotherapy hereafter referred to as Part 2A Part 2 Combination Safety Run-in Part2B or Part 2 Combination Part2C
Various types of B-cell NHLs are studied including diffuse large B cell lymphoma DLBCL high-grade B cell lymphoma HGBCL mantle cell lymphoma MCL primary mediastinal large B-cell lymphoma PMBCL follicular lymphoma FL marginal zone lymphoma MZL and chronic lymphocytic leukemiasmall lymphocytic lymphoma CLLSLL
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 |
|---|---|---|---|
| NL7202505620 | REGISTRY | The Netherlands CCMO | None |
| 2019-002752-16 | EUDRACT_NUMBER | None | None |