Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMM-6-415 · 1 trial · 4 indications
Number of participants with adverse events
Number of participants with dose-limiting toxicities
Selection of candidate RP2D to take forward into Ph2a
Cmax
Tmax
AUC0-t
Surrogate PD Biomarker Assay, pERK
The proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR), based on RECIST 1.1 criteria
| Arm | Type | Description |
|---|---|---|
| IMM-6-415 | EXPERIMENTAL | Dose Escalation and Dose Expansion |
| Name | Type | Description |
|---|---|---|
| IMM-6-415 | DRUG | Twice daily, oral tablet administered in 21-day cycles until treatment discontinuation criteria are met. |
Inclusion Criteria: * Age ≥18 years * Life expectancy \>16 weeks * Part 1: Histologically or cytologically confirmed diagnosis of a locally advanced unresectable or metastatic solid tumor malignancy harboring RAS (NRAS, KRAS, or HRAS)- or RAF- (ARAF, BRAF, RAF1) activating mutations, as documented ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
IMM-6-415 is an investigational small molecule being studied for advanced solid tumors, including pancreas adenocarcinoma, non-small cell lung cancer, and cutaneous malignant melanoma. It is being developed by Immuneering Corporation for patients with RAS or RAF mutant solid tumors, a biomarker-selected population. It is not approved for any indication and remains in clinical development.
IMM-6-415 is being developed by Immuneering Corporation, which trades on the Nasdaq under the ticker IMRX. The company is the sponsor of the clinical program evaluating the small molecule in biomarker-selected advanced solid tumors.
IMM-6-415 is in Phase 1 clinical development. Its single registered trial, NCT06208124, is listed as completed and enrolled 30 participants. The study was an uncontrolled, non-randomized, open-label Phase 1 trial, so IMM-6-415 is investigational and has not been approved by the FDA for any use.
IMM-6-415 has been evaluated in one registered clinical trial, NCT06208124, titled A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors. The Phase 1 trial enrolled 30 adults aged 18 years and older in the United States and is listed as completed. It included patients with advanced solid tumors, pancreas adenocarcinoma, non-small cell lung cancer, and cutaneous malignant melanoma.
IMM-6-415 is a small molecule developed for RAS and RAF mutant solid tumors, and the Phase 1 trial NCT06208124 selected patients on that RAS/RAF mutant biomarker. The trial enrolled patients with advanced solid tumors, pancreas adenocarcinoma, non-small cell lung cancer, and cutaneous malignant melanoma.