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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)
NCT0620812430
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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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