NCT06208124

A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors

A Phase 1/2a Study of IMM-6-415 in Participants With Advanced or Metastatic Malignancies Harboring RAS or RAF Oncogenic Mutations

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Immuneering Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a FIH, ascending dose study to characterize the safety, tolerability, optimal dose and preliminary anti-tumor activity of IMM-6-415 in participants with advanced or metastatic solid tumors harboring RAS or RAF oncogenic mutations.

Detailed description

The dose exploration will identify the candidate recommended Phase 2 dose (RP2D) of IMM-6-415 to further explore the anti-tumor activity of IMM-6-415 as monotherapy in Phase 2a tumor-specific cohorts. Patients will be self-administering IMM-6-415 on a daily basis for up to 16 cycles (21-day cycles). During the first 2 cycles, PK and PD will be assessed. Solid tumor types with RAS/RAF mutations are eligible.

Conditions

• Advanced Solid Tumor (Phase 1)
• Pancreas Adenocarcinoma
• Non-small Cell Lung Cancer
• Malignant Melanoma (Cutaneous)

Interventions

Type	Name	Description
DRUG	IMM-6-415	Twice daily, oral tablet administered in 21-day cycles until treatment discontinuation criteria are met.

Timeline

• Start date: 2024-02-27
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2024-01-17
• Last updated: 2025-05-28

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study