Ignite Creation Date:
2024-05-06 @ 8:46 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02829099
Status:
COMPLETED
Last Update Posted:
2022-10-06
First Post:
2016-07-07
Brief Title:
A Study of Safety Pharmacokinetics and Pharmacodynamics of JNJ-64457107 in Participants With Advanced Stage Tumors
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 1 Open-Label Study of the Safety Pharmacokinetics and Pharmacodynamics of JNJ-64457107 an Agonistic Human Monoclonal Antibody Targeting CD40 in Patients With Advanced Stage Solid Tumors
Status:
COMPLETED
Status Verified Date:
2022-10
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 primary purpose of the study is to determine the recommended Phase 2 dose RP2D and schedule of JNJ-64457107 when administered intravenously IV to participants with advanced stage solid tumors in Part 1 and to further characterize the safety of JNJ-64457107 when administered IV to participants with non-small cell lung cancer NSCLC pancreatic cancer and cutaneous melanoma in Part 2
Detailed Description:
This study has 2 parts Dose Escalation part 1 and Dose Expansion part 2 which are conducted in 3 phases Screening Phase up to 28 days prior to first dose of study drug and includes procedures like electrocardiogram ECG serum pregnancy test Treatment phase continues until the completion of the End-of-Treatment Visit 30 days after last dose of study drug and Post-treatment follow-up phase continues until the participant has died is lost to follow-up or has withdrawn consent or the study ends In follow-up participants will continue to be monitored for survival status and subsequent cancer-related therapies until the end of study Additional bio-markers will be assessed in an optional sub-study to define the impact of JNJ-64457107 on innate and adaptive immune responses in tumors Safety will be monitored throughout the study by Safety Evaluation Team SET
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 64457107CAN1001 | OTHER | None | None |
| 2016-000969-23 | EUDRACT_NUMBER | Janssen Research Development LLC | None |