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IMM-6-415

Phase 1

Advanced Solid Tumor (Phase 1) | Small molecule | Oncology |Immuneering Corporation|Last Updated: May 28, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

IMM-6-415 · 1 trial · 4 indications

Phase 1 1
NCT06208124A Study of IMM-6-415 in RAS/RAF Mutant Solid TumorsAdvanced Solid Tumor (Phase 1)
COMPLETED30 Analytics
PHASE1COMPLETED
A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors
Advanced Solid Tumor (Phase 1)Unlock trial analytics

Study Endpoints

Primary Endpoints

Phase 1/2a: Adverse Events
From treatment initiation through 30 days following the last IMM-6-415 dose

Number of participants with adverse events

Phase 1: Dose-Limiting Toxicities (DLT)
The first 21 days of study treatment

Number of participants with dose-limiting toxicities

Phase 1: Recommended Phase 2 Dose (RP2D) candidate
Initiation of study treatment through 21 days (up to approximately 18 months)

Selection of candidate RP2D to take forward into Ph2a

Phase 1: Maximum Observed Plasma Concentration of IMM-6-415
After 9 weeks (3 Cycles) of study treatment

Cmax

Phase 1: Time to Reach Maximum Observed Plasma Concentration of IMM-6-415
After 9 weeks (3 Cycles) of study treatment

Tmax

Phase 1: Area Under Plasma Concentration (AUC) Time Curve of IMM-6-415
After 9 weeks (3 Cycles) of study treatment

AUC0-t

Phase 1: Pharmacodynamic (PD) Activity of IMM-6-415 Plasma Concentrations Over Time
After 9 weeks (3 Cycles) of study treatment

Surrogate PD Biomarker Assay, pERK

Phase 2a: Overall Response Rate (ORR)
After up to 48 weeks (16 cycles) of study treatment

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

Secondary Endpoints

Phase 2a: Maximum Observed Plasma Concentration of IMM-6-415
After 9 weeks (3 Cycles) of study treatment
Phase 2a: Time to Reach Maximum Observed Plasma Concentration of IMM-6-415
After 9 weeks (3 Cycles) of study treatment
Phase 2a: Area Under Plasma Concentration (AUC) Time Curve of IMM-6-415
After 9 weeks (3 Cycles) of study treatment
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IMM-6-415EXPERIMENTALDose Escalation and Dose Expansion

Interventions

NameTypeDescription
IMM-6-415DRUGTwice daily, oral tablet administered in 21-day cycles until treatment discontinuation criteria are met.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

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 ...

Countries:United States
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Frequently asked questions about IMM-6-415

What is IMM-6-415 used for?

IMM-6-415 is an investigational small molecule being studied for the treatment of advanced solid tumors, including pancreas adenocarcinoma, non-small cell lung cancer, and cutaneous malignant melanoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does IMM-6-415 target?

IMM-6-415 is designed to target tumors with RAS/RAF mutations, as indicated by the clinical trial title. It is a small molecule therapeutic being developed for cancers that harbor these genetic alterations, which are common in several solid tumor types.

Who is developing IMM-6-415?

IMM-6-415 is being developed by Immuneering Corporation, a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced solid tumors.

What phase is IMM-6-415 in?

IMM-6-415 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug remains under investigation for safety and dosing.

What clinical trials is IMM-6-415 in?

IMM-6-415 has been studied in one clinical trial with the identifier NCT06208124, titled 'A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors.' This Phase 1 trial enrolled 30 participants with advanced solid tumors and was completed in the United States.

Is IMM-6-415 the same as other drugs?

IMM-6-415 is a unique investigational drug developed by Immuneering Corporation. No alternative names for this drug have been reported in the available clinical trial information. It is being studied specifically for RAS/RAF mutant solid tumors.