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

Sponsor: Immuneering Corporation

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05585320

Patient View

This open-label study evaluates the safety, tolerability, and preliminary anti-tumor activity of IMM-1-104, alone or with approved agents, in adults with RAS-mutant advanced solid tumors. Eligible participants must have measurable disease and adequate organ function. Interventions include IMM-1-104 monotherapy or in combination with gemcitabine/nab-paclitaxel or modified FOLFIRINOX.

Patient Parameters

Program Overview

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 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 tumor malignancy that harbors a RAS (KRAS, NRAS, or HRAS) activating mutation.
    2. Monotherapy Phase 2a: A locally advanced unresectable or metastatic solid tumor malignancies: pancreatic ductal adenocarcinoma (PDAC), RAS-mutant melanoma, or RAS-mutant non-small cell lung cancer (NSCLC)
    3. Combination therapy (both phases): A locally advanced unresectable or metastatic PDAC

  • Participants must be treatment naive or received prior systemic standard-of-care treatment as follows:

    1. Monotherapy Phase 1: received at least 1 line of systemic standard-of-care treatment for their advanced or metastatic disease

    2. Monotherapy Phase 2a:

      1. First-line PDAC participants will have received no previous systemic anti-cancer therapy. Second-line PDAC participants will have received no more than one prior systemic anti-cancer therapy.
      2. First-line melanoma participants will have received no previous systemic anti-cancer therapy. Second- and third-line participants will have received and failed one or two prior systemic anti-cancer therapies, respectively.
      3. NSCLC participants will have received at least one and no more than two previous lines of systemic therapy.

    3. Combination therapy (both phases): PDAC participants will have received no previous systemic anti-cancer therapy for their advanced or metastatic disease.

  • Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria

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

  • Adequate organ function

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 risk factors for RVO. History of serous retinopathy, retinal edema, or retinal pigment epithelial 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 start of study treatment
  • Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.

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