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NCT04006301 · ClinicalTrials.gov registry record · Phase 1

First-in-Human Study of JNJ-74699157 in Participants With Tumors Harboring the KRAS G12C Mutation

A Phase 1 study, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 1
Development phase
10
Enrollment target

NCT04006301: Completed Phase 1 study, sponsored by Janssen Research & Development.

NCT04006301 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04006301, a Phase 1 study, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study 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).

Primary Outcome

DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.

Interventions

  • DRUG JNJ-74699157

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2019-07-26
Est. Completion 2020-07-13
Phase Phase 1
Janssen Research & Development

593 total trials

What the finished NCT04006301 record still lists

NCT04006301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which JNJ-74699157 is the first listed.

NCT04006301 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04006301 about?

NCT04006301 is a clinical study titled "First-in-Human Study of JNJ-74699157 in Participants With Tumors Harboring the KRAS G12C Mutation". 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 determin...

What is the current status of trial NCT04006301?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2019-07-26. Estimated completion is 2020-07-13.

What interventions are being tested in trial NCT04006301?

The interventions under investigation include: JNJ-74699157 (DRUG).

Who is sponsoring clinical trial NCT04006301?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04006301's enrollment target sits among peer trials

10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04006301, the US trial registry maintained by the National Library of Medicine. NCT04006301 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.