Ignite Creation Date:
2024-05-06 @ 3:46 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02376699
Status:
TERMINATED
Last Update Posted:
2023-05-01
First Post:
2015-02-17
Brief Title:
Safety Study of SEA-CD40 in Cancer Patients
Sponsor:
Seagen Inc
Organization:
Seagen Inc
Study Overview
Official Title:
A Phase 1 Open-label Dose-escalation Study of SEA-CD40 in Adult Patients With Advanced Malignancies
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed due to portfolio prioritization
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to find out if SEA-CD40 is safe and effective when given alone in combination with pembrolizumab and in combination with pembrolizumab gemcitabine and nab-paclitaxel The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects Different dose regimens will be evaluated Different methods of administration may be evaluated The pharmacokinetics pharmacodynamic effects biomarkers of response and antitumor activity of SEA-CD40 will also be evaluated
Detailed Description:
The study will be conducted in the following parts
Part A Intravenous IV monotherapy dose-regimen finding for solid tumors -- Dose-escalation and possible dose-interval modification to lengthen the treatment cycle to define the IV SEA-CD40 monotherapy maximum tolerated dose MTD andor the optimal biological dose OBD regimens in patients with solid tumors The ability to increase the dose intensity to give additional doses within a treatment cycle may be evaluated
Part B IV monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with doses at or below the IV SEA-CD40 monotherapy MTD andor OBD determined in Part A
Part C IV monotherapy dose-regimen finding for lymphomas -- Dose-escalation and possible dose-interval modification to lengthen the treatment cycle to define the IV SEA-CD40 monotherapy MTD andor the OBD regimens in patients with lymphomas The ability to increase the dose intensity to give additional doses within a treatment cycle may be evaluated
Part D IV monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion cohorts may be enrolled where patients will be treated with doses at or below the IV SEA-CD40 monotherapy MTD andor OBD determined in Part C
Part E Combination therapy dose-regimen finding for solid tumors -- IV SEA-CD40 dose-escalation to define the MTD andor the OBD regimen to be administered in combination with standard approved dose of pembrolizumab in patients with solid tumors
Part F Combination therapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with IV SEA-CD40 and pembrolizumab combination therapy doses of SEA-CD40 will be at or below the MTD andor OBD determined in Part E
Part G Subcutaneous SC injection injected under the skin monotherapy dose-regimen finding for solid tumors -- Dose-escalation and possible dose-interval modification to lengthen the treatment cycle to define the SC SEA-CD40 monotherapy maximum tolerated dose MTD andor the optimal biological dose OBD regimens in patients with solid tumors
Part H SC monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with doses at or below the SC SEA-CD40 monotherapy MTD andor OBD determined in Part G
Note There is no Part I
Part J SC monotherapy dose-regimen finding for lymphomas -- Dose-escalation and possible dose-interval modification to lengthen the treatment cycle to define the SC SEA-CD40 monotherapy MTD andor the OBD regimens in patients with lymphomas
Part K SC monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion cohorts may be enrolled where patients will be treated with doses at or below the SC SEA-CD40 monotherapy MTD andor OBD determined in Part J
Part L Combination therapy in pancreatic cancer -- Patients will be treated with SEA-CD40 doses at or below MTD andor OBD An established dose of pembrolizumab and a standard regimen of gemcitabine and nab-paclitaxel will be used
In Parts A C E G and J a maximum feasible dose MFD will be defined if an MTD andor OBD cannot be identified Parts B D F H K and L will explore the recommended dosing regimen once the MTD andor OBD or MFD if the MTD andor OBD cannot be identified has been determined
Part A Intravenous IV monotherapy dose-regimen finding for solid tumors -- Dose-escalation and possible dose-interval modification to lengthen the treatment cycle to define the IV SEA-CD40 monotherapy maximum tolerated dose MTD andor the optimal biological dose OBD regimens in patients with solid tumors The ability to increase the dose intensity to give additional doses within a treatment cycle may be evaluated
Part B IV monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with doses at or below the IV SEA-CD40 monotherapy MTD andor OBD determined in Part A
Part C IV monotherapy dose-regimen finding for lymphomas -- Dose-escalation and possible dose-interval modification to lengthen the treatment cycle to define the IV SEA-CD40 monotherapy MTD andor the OBD regimens in patients with lymphomas The ability to increase the dose intensity to give additional doses within a treatment cycle may be evaluated
Part D IV monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion cohorts may be enrolled where patients will be treated with doses at or below the IV SEA-CD40 monotherapy MTD andor OBD determined in Part C
Part E Combination therapy dose-regimen finding for solid tumors -- IV SEA-CD40 dose-escalation to define the MTD andor the OBD regimen to be administered in combination with standard approved dose of pembrolizumab in patients with solid tumors
Part F Combination therapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with IV SEA-CD40 and pembrolizumab combination therapy doses of SEA-CD40 will be at or below the MTD andor OBD determined in Part E
Part G Subcutaneous SC injection injected under the skin monotherapy dose-regimen finding for solid tumors -- Dose-escalation and possible dose-interval modification to lengthen the treatment cycle to define the SC SEA-CD40 monotherapy maximum tolerated dose MTD andor the optimal biological dose OBD regimens in patients with solid tumors
Part H SC monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with doses at or below the SC SEA-CD40 monotherapy MTD andor OBD determined in Part G
Note There is no Part I
Part J SC monotherapy dose-regimen finding for lymphomas -- Dose-escalation and possible dose-interval modification to lengthen the treatment cycle to define the SC SEA-CD40 monotherapy MTD andor the OBD regimens in patients with lymphomas
Part K SC monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion cohorts may be enrolled where patients will be treated with doses at or below the SC SEA-CD40 monotherapy MTD andor OBD determined in Part J
Part L Combination therapy in pancreatic cancer -- Patients will be treated with SEA-CD40 doses at or below MTD andor OBD An established dose of pembrolizumab and a standard regimen of gemcitabine and nab-paclitaxel will be used
In Parts A C E G and J a maximum feasible dose MFD will be defined if an MTD andor OBD cannot be identified Parts B D F H K and L will explore the recommended dosing regimen once the MTD andor OBD or MFD if the MTD andor OBD cannot be identified has been determined
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PN 863 | OTHER | Merck Sharp Dohme Corp | None |