A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors

Last updated: February 18, 2025
Sponsor: Immuneering Corporation
Overall Status: Active - Recruiting

Phase

1/2

Condition

Melanoma

Pancreatitis

Pancreatic Cancer

Treatment

IMM-1-104 Monotherapy (Treatment Group A)

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

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

Clinical Study ID

NCT05585320
IMM1104-101
  • Ages > 18
  • All Genders

Study 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 dose (RP2D) 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must be ≥18 years of age

  • Must have histologically or cytologically confirmed diagnosis as follows:

  1. Monotherapy Phase 1: A locally advanced unresectable or metastatic solid tumormalignancy that harbors a RAS (KRAS, NRAS, or HRAS) activating mutation.

  2. Monotherapy Phase 2a: A locally advanced unresectable or metastatic solid tumormalignancies: pancreatic ductal adenocarcinoma (PDAC), RAS-mutant melanoma, orRAS-mutant non-small cell lung cancer (NSCLC)

  3. Combination therapy (both phases): A locally advanced unresectable ormetastatic PDAC

  • Participants must be treatment naive or received prior systemic standard-of-caretreatment as follows:
  1. Monotherapy Phase 1: received at least 1 line of systemic standard-of-caretreatment for their advanced or metastatic disease

  2. Monotherapy Phase 2a:

  3. First-line PDAC participants will have received no previous systemicanti-cancer therapy. Second-line PDAC participants will have received nomore than one prior systemic anti-cancer therapy.

  4. First-line melanoma participants will have received no previous systemicanti-cancer therapy. Second- and third-line participants will havereceived and failed one or two prior systemic anti-cancer therapies,respectively.

  5. NSCLC participants will have received at least one and no more than twoprevious lines of systemic therapy.

  6. Combination therapy (both phases): PDAC participants will have received noprevious systemic anti-cancer therapy for their advanced or metastatic disease.

  • Must have evidence of measurable disease (at least one target lesion) per RECISTv1.1 criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Adequate organ function

Exclusion

Exclusion Criteria:

  • Inability to swallow oral medications

  • Symptomatic, untreated, or actively progressing known central nervous system (CNS)metastases

  • History or concurrent evidence of retinal vein occlusion (RVO) or current riskfactors for RVO. History of serous retinopathy, retinal edema, or retinal pigmentepithelial detachment (RPED)

  • Impaired cardiovascular function or clinically significant cardiac disease

  • History of rhabdomyolysis within 3 months prior to start of study treatment

  • Active skin disorder requiring systemic treatment within 3 months prior to the startof study treatment

  • Females who are pregnant, breastfeeding, or planning to become pregnant and maleswho plan to father a child while enrolled in this study.

Study Design

Total Participants: 210
Treatment Group(s): 3
Primary Treatment: IMM-1-104 Monotherapy (Treatment Group A)
Phase: 1/2
Study Start date:
October 31, 2022
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Mayo Clinic

    Scottsdale, Arizona 85259
    United States

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • University of California San Diego

    San Diego, California 92037
    United States

    Active - Recruiting

  • Sarcoma Oncology Center

    Santa Monica, California 90403
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Florida Cancer Specialists and Research Institute

    Lake Mary, Florida 32746
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Hematology Oncology Associates of Central New York

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York, New York 10021
    United States

    Active - Recruiting

  • Levine Cancer Center

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Duke University Cancer Institute

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 27203
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Site Not Available

  • NEXT Oncology

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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