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JNJ-74699157

Phase 1

Neoplasms | Small molecule | Oncology |Johnson & Johnson|Last Updated: Nov 6, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-74699157 · 1 trial · 4 indications

Phase 1 1
NCT04006301First-in-Human Study of JNJ-74699157 in Participants With Tumors Harboring the KRAS G12C MutationNeoplasms
COMPLETED10 Analytics
PHASE1COMPLETED
First-in-Human Study of JNJ-74699157 in Participants With Tumors Harboring the KRAS G12C Mutation
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
Up to 2 years

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

Part 1 and Part 2: Number of Participants with Adverse Events (AEs)
Up to 4 years

An AE is any untoward medical occurrence in a participant who received study drug without regard to causal relationship.

Part 1 and Part 2: Number of Participants with AE's by Severity
Up to 4 years

Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life threatening consequences; Grade 5: Death.

Part 2: Overall Response Rate (ORR)
Up to 4 years

ORR is defined as the percentage of participants who have a partial response (PR) or better response as per RECIST v.1.1. PR criteria in solid tumors (RECIST) is greater than or equal to (\>=) 30 percent (%) decrease in the sum of the diameters of all index lesions compared with baseline in 2 observations at least 4 weeks apart, in absence of new lesions or unequivocal progression of non-index lesions.

Secondary Endpoints

Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-74699157
Up to 4 years
Part 1 and Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-74699157
Up to 4 years
Part 1 and 2: Area Under Plasma-concentration Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUC [0-last])
Up to 4 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Dose EscalationEXPERIMENTALParticipants 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.
Part 2: Dose ExpansionEXPERIMENTALTwo 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.

Interventions

NameTypeDescription
JNJ-74699157DRUGParticipants will receive JNJ-74699157 orally.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Kirsten rat sarcoma virus homolog (KRAS) glycine-to-cysteine (G12C) mutation in tumor tissue or blood * Histological documentation of disease: Part 1: Histologically or cytologically confirmed solid tumor malignancy that is metastatic or unresectable, Part 2: (a) unresectable,...

Countries:United StatesFrance
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Frequently asked questions about JNJ-74699157

What is JNJ-74699157 used for?

JNJ-74699157 is an investigational small molecule being studied for the treatment of neoplasms, including advanced solid tumors, non-small cell lung cancer, and colorectal cancer. It is being developed for patients whose tumors harbor the KRAS G12C mutation. The drug is currently in Phase 1 clinical development.

What does JNJ-74699157 target?

JNJ-74699157 targets tumors that harbor the KRAS G12C mutation. It is designed to act on cancers with this specific genetic alteration. The drug is being evaluated in patients with advanced solid tumors, non-small cell lung cancer, and colorectal cancer that carry the KRAS G12C mutation.

Who makes JNJ-74699157?

JNJ-74699157 is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker JNJ. The drug is an investigational small molecule in Phase 1 clinical development for the treatment of neoplasms, including advanced solid tumors, non-small cell lung cancer, and colorectal cancer.

What phase is JNJ-74699157 in?

JNJ-74699157 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in a first-in-human trial for patients with tumors harboring the KRAS G12C mutation, including advanced solid tumors, non-small cell lung cancer, and colorectal cancer.

What clinical trials is JNJ-74699157 in?

JNJ-74699157 is being studied in a Phase 1 clinical trial with the identifier NCT04006301. This first-in-human study enrolled 10 participants with tumors harboring the KRAS G12C mutation, including advanced solid tumors, non-small cell lung cancer, and colorectal cancer. The trial was conducted in the United States and France and has been completed.

Is JNJ-74699157 FDA approved?

JNJ-74699157 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied for the treatment of neoplasms, including advanced solid tumors, non-small cell lung cancer, and colorectal cancer, in patients with tumors harboring the KRAS G12C mutation.