First-in-Human Study of JNJ-74699157 in Participants With Tumors Harboring the KRAS G12C Mutation
NCT04006301 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2020-11-06
Summary
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JNJ-74699157 in participants with advanced solid tumors harboring a kirsten rat sarcoma virus homolog (KRAS) glycine-to-cysteine (G12C) mutation (Part 1: Dose escalation) and to determine the safety and preliminary antitumor activity of JNJ-74699157 at the RP2D regimen in participants with advanced solid tumors harboring a KRAS G12C mutation (Part 2: Dose expansion).
Conditions
Interventions
- DRUG
-
JNJ-74699157
Participants will receive JNJ-74699157 orally.
Sponsors & Collaborators
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-26
- Primary Completion
- 2020-07-13
- Completion
- 2020-07-13
- FDA Drug
- Yes
Countries
- United States
- France
Study Locations
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