Active Not RecruitingPhase 1 / Phase 2NCT05585320

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

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.

Checked against the public recordLast updated Sep 2, 2025 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 1 / Phase 2
U.S. locations20
SponsorImmuneering Corporation
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Immuneering Corporation
Interventions being studied
Drug: IMM-1-104 Monotherapy (Treatment Group A); Drug: IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B); Drug: IMM-1-104 + modified FOLFIRINOX (Treatment Group C); Drug: IMM-1-104 + dabrafenib (Treatment Group D); Drug: IMM-1-104 + pembrolizumab (Treatment Group E)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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 4. Combination therapy Phase 2a, Treatment D: Second and third line participants with unresectable stage III or stage IV cutaneous melanoma with BRAF mutation. Must have progressed on or after treatment with an anti-PD-(L)1 monoclonal antibody as the most recent therapy. First day of study treatment must be more than 28 days but less than 12 weeks from the last dose of anti-PD-(L)1 mAb. 5. Combination therapy Phase 2a, Treatment E: Second and third line participants with unresectable stage III or stage IV cutaneous melanoma. Must have progressed on or after treatment with an anti-PD-(L)1 monoclonal antibody as the most recent therapy. First day of study treatment must be more than 28 days but less than 12 weeks from the last dose of anti-PD-(L)1 mAb. * 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 * Participants with active, uncontrolled autoimmune disease or participants actively being treated with tumor necrosis factor-alpha (TNF-alpha) inhibitors for management of their autoimmune disease are excluded * Receipt of an allogeneic tissue/solid organ transplant * Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo ClinicScottsdale, Arizona
  • City of HopeDuarte, California
  • University of California San DiegoSan Diego, California
  • Sarcoma Oncology CenterSanta Monica, California
  • Sarah Cannon Research InstituteDenver, Colorado
  • Mayo ClinicJacksonville, Florida
  • Florida Cancer Specialists and Research InstituteLake Mary, Florida
  • Northwestern UniversityChicago, Illinois
  • University of ChicagoChicago, Illinois
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • Mayo ClinicRochester, Minnesota
  • Hematology Oncology Associates of Central New YorkEast Syracuse, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 2, 2025. Always confirm current availability with the study team.

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