Condition or disease | Intervention/treatment | Phase |
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Neoplasms Advanced Solid Tumors Non-small Cell Lung Cancer Colorectal Cancer | Drug: JNJ-74699157 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A First-in-Human Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of JNJ-74699157 in Participants With Advanced Solid Tumors Harboring the KRAS G12C Mutation |
Actual Study Start Date : | July 26, 2019 |
Actual Primary Completion Date : | July 13, 2020 |
Actual Study Completion Date : | July 13, 2020 |
Arm | Intervention/treatment |
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Experimental: Part 1: Dose Escalation
Participants with advanced solid tumors harboring the kirsten rat sarcoma virus homolog (KRAS) glycine-to-cysteine (G12C) mutation will receive oral administration of JNJ-74699157. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.
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Drug: JNJ-74699157
Participants will receive JNJ-74699157 orally.
Other Name: ARS-3248
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Experimental: Part 2: Dose Expansion
Two groups of participants with either non-small cell lung cancer or other solid tumors harboring KRAS G12C mutation will receive JNJ-74699157 at RP2D determined in Part 1.
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Drug: JNJ-74699157
Participants will receive JNJ-74699157 orally.
Other Name: ARS-3248
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Florida Cancer Specialists | |
Sarasota, Florida, United States, 34232 | |
H. Lee Moffitt Cancer & Research Institute | |
Tampa, Florida, United States, 33612 | |
United States, Tennessee | |
Sarah Cannon Research Institute | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
NEXT Oncology | |
San Antonio, Texas, United States, 78229 | |
France | |
Centre Leon Bérard | |
Lyon Cedex 8, France, 69373 | |
Hopital de la Timone | |
Marseille, France, 13885 | |
Institut Gustave Roussy | |
Villejuif, France, 94800 |
Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Tracking Information | |||||||
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First Submitted Date ICMJE | July 2, 2019 | ||||||
First Posted Date ICMJE | July 5, 2019 | ||||||
Last Update Posted Date | November 6, 2020 | ||||||
Actual Study Start Date ICMJE | July 26, 2019 | ||||||
Actual Primary Completion Date | July 13, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | First-in-Human Study of JNJ-74699157 in Participants With Tumors Harboring the KRAS G12C Mutation | ||||||
Official Title ICMJE | A First-in-Human Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of JNJ-74699157 in Participants With Advanced Solid Tumors Harboring the KRAS G12C Mutation | ||||||
Brief 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). | ||||||
Detailed Description | KRAS is one of the most frequently mutated genes in human cancer. KRAS mutations lead to activation of cellular signaling that promotes tumor growth, and KRAS may therefore be a candidate target for anticancer therapy. This study will evaluate JNJ-74699157, a potent and specific, orally bioavailable inhibitor of the glycine-to-cysteine (G12C) mutant KRAS protein, which is found in non-small cell lung cancers and other solid tumor types. This study will enroll participants with advanced solid tumors harboring the KRAS G12C mutation and will be conducted in 2 parts. Part 1 (Dose Escalation) will be carried out in sequential cohorts of single or multiple participants at doses assigned by the study evaluation team to determine the MTD and RP2D of JNJ-74699157. Participants in Part 2 (Dose Expansion) will receive JNJ-74699157 at the RP2D determined in Part 1 to determine the safety and preliminary antitumor activity of the RP2D. Key efficacy assessments include radiographic imaging evaluations, physical examination, and tumor markers. Safety evaluations will include monitoring of adverse events, vital signs, laboratory evaluations, cardiac monitoring and physical examination findings. The study consists of a screening phase, treatment phase, and a post-treatment follow-up phase. An end-of-treatment visit will occur within 30 days of the last dose of study drug or prior to the start of a subsequent anticancer therapy, whichever comes first. The study duration will be up to 4 years. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: JNJ-74699157
Participants will receive JNJ-74699157 orally.
Other Name: ARS-3248
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
10 | ||||||
Original Estimated Enrollment ICMJE |
140 | ||||||
Actual Study Completion Date ICMJE | July 13, 2020 | ||||||
Actual Primary Completion Date | July 13, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | France, United States | ||||||
Removed Location Countries | Spain | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04006301 | ||||||
Other Study ID Numbers ICMJE | CR108652 2019-000565-21 ( EudraCT Number ) 74699157STM1001 ( Other Identifier: Janssen Research & Development, LLC ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Janssen Research & Development, LLC | ||||||
Study Sponsor ICMJE | Janssen Research & Development, LLC | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Janssen Research & Development, LLC | ||||||
Verification Date | November 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |