A Study of Safety, Pharmacokinetics and Pharmacodynamics of JNJ-64457107 in Participants With Advanced Stage Tumors
NCT02829099 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 95
Last updated 2022-10-06
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.
Conditions
- Advanced Solid Neoplasms
Interventions
- DRUG
-
JNJ-64457107
JNJ-64457107 administered by IV infusion on Day 1 and 14 of a 28-day cycle.
Sponsors & Collaborators
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-21
- Primary Completion
- 2021-07-01
- Completion
- 2021-07-29
- FDA Drug
- Yes
Countries
- Israel
- Spain
Study Locations
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