A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors

Summary

This is an open-label, dose-exploration and expansion study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of IMM-1-104 when administered as monotherapy or in combination with approved agents in participants with RAS-mutated or RAS/MAPK activated advanced or metastatic solid tumors. The dose exploration will identify the candidate recommended Phase 2 candidate optimal dose of IMM-1-104 to further explore the anti-tumor activity of IMM-1-104 as monotherapy and in combination with approved agents in multiple Phase 2a proof-of-concept cohorts in malignancies of interest.

Conditions

• Advanced Solid Tumor
• Pancreatic Adenocarcinoma
• Malignant Melanoma (Cutaneous)
• Non-small Cell Lung Cancer (NSCLC)

Interventions

DRUG

IMM-1-104 Monotherapy (Treatment Group A)

Once-daily, oral IMM-1-104 dose administered in 28-day cycles until treatment discontinuation criteria are met

DRUG

IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B)

Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with intravenous infusions of gemcitabine and nab-paclitaxel until treatment discontinuation criteria are met. Gemcitabine will be administered at a dose of 1000 mg/m\^2 nab-Paclitaxel will be administered at a dose of 125 mg/m\^2

DRUG

IMM-1-104 + modified FOLFIRINOX (Treatment Group C)

Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with intravenous infusions of modified FOLFIRNOX until treatment discontinuation criteria are met. FOLFIRINOX will be administered as follows: Folinic Acid will be administered at 400 mg/m\^2 Fluorouracil will be administered at 2400 mg/m\^2 Irinotecan will be administered at 150 mg/m\^2 Oxaliplatin will be administered at 85 mg/m\^2

DRUG

IMM-1-104 + dabrafenib (Treatment Group D)

Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with twice daily oral dose of dabrafenib until treatment discontinuation criteria are met. Dabrafenib will be administered at a dose of 150mg daily (75mg twice daily).

DRUG

IMM-1-104 + pembrolizumab (Treatment Group E)

Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with intravenous infusions of pembrolizumab in sequence or concurrently depending on the enrolled cohort (two sub cohorts) until treatment discontinuation criteria are met. Pembrolizumab will be administered at a dose of 400mg.

Sponsors & Collaborators

• Immuneering Corporation

  lead INDUSTRY

Principal Investigators

• Vinny Hayreh, MD · Immuneering Corporation

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-31

Primary Completion

2026-06-30

Completion

2027-06-30

FDA Drug

Yes

Countries

• United States

Study Locations