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Testing IMM-1-104 for advanced solid tumors

A Phase 1/2a, Open-Label, Multicenter, Nonrandomized, Safety and Anti-tumor Activity Study of IMM-1-104, a Novel Oral Dual MEK1/2 Inhibitor in Participants With Advanced or Metastatic Solid Tumors

Phase1; Phase2 Interventional Immuneering Corporation · NCT05585320

This study is testing a new treatment called IMM-1-104 for people with advanced solid tumors that have RAS mutations to see if it can help them feel better, either on its own or with other cancer therapies.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment320 (estimated)
Ages18 Years and up
SexAll
SponsorImmuneering Corporation Industry-sponsored
Locations20 sites (Scottsdale, Arizona and 19 other locations)
Trial IDNCT05585320 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of IMM-1-104 in patients with advanced or metastatic solid tumors that have RAS mutations. It involves both monotherapy and combination therapy approaches, exploring various treatment regimens to determine the optimal dose and anti-tumor activity. Participants will receive IMM-1-104 alone or in combination with established therapies like Gemcitabine, nab-Paclitaxel, FOLFIRINOX, dabrafenib, or pembrolizumab. The study aims to identify promising treatment options for patients with difficult-to-treat cancers.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced or metastatic solid tumors that have RAS mutations, particularly those with pancreatic cancer, melanoma, or non-small cell lung cancer.

Not a fit: Patients without RAS mutations or those with early-stage tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with advanced solid tumors harboring RAS mutations.

How similar studies have performed: Other studies targeting RAS mutations have shown promise, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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
  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.

Where this trial is running

Scottsdale, Arizona and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid TumorPancreatic AdenocarcinomaMalignant MelanomaNon-small Cell Lung Cancerpan-RASKRASNRASHRAS
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.