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Also known as ARS-3248
JNJ-74699157 · 1 trial · 4 indications
DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.
An AE is any untoward medical occurrence in a participant who received study drug without regard to causal relationship.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation | EXPERIMENTAL | 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. |
| Part 2: Dose Expansion | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| JNJ-74699157 | DRUG | Participants will receive JNJ-74699157 orally. |
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,...
Top 14 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | Luspatercept, Fedratinib, BMS-986158 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, ABBV-744, IMGN632 |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Incyte Corporation | INCY | 8 | PHASE2 | Ruxolitinib, INCB160058, INCB057643, INCA033989, INCA036978 |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Momelotinib |
| Eli Lilly and Company | LLY | 2 | PHASE1 | LY3410738, LY5830966 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Damora Therapeutics, Inc. | DMRA | 2 | PHASE2 | GB2064, DMR-001 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE1 | Revumenib |
JNJ-74699157 is an investigational small molecule developed by Johnson & Johnson for the treatment of advanced solid tumors that harbor the KRAS G12C mutation. It was studied in a Phase 1 first-in-human trial in adults with neoplasms, including non-small cell lung cancer and colorectal cancer.
JNJ-74699157 was developed for the treatment of advanced solid tumors, including non-small cell lung cancer and colorectal cancer, in patients whose tumors carry the KRAS G12C mutation. It is an investigational agent and has not been approved for any indication.
JNJ-74699157 is made by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company developed the compound as part of its oncology pipeline targeting KRAS G12C mutant tumors.
JNJ-74699157 is in Phase 1 development. Its only clinical trial, a first-in-human study, has been completed. The drug remains investigational and is not approved by the FDA for any use.
JNJ-74699157 was evaluated in one clinical trial, NCT04006301, titled First-in-Human Study of JNJ-74699157 in Participants With Tumors Harboring the KRAS G12C Mutation. The Phase 1 trial enrolled 10 participants across the United States and France and is now completed.