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A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors
NCT05585320 · View on ClinicalTrials.gov ↗
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 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 Studied
Interventions
- 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)
Study Locations (20)
California
- City of Hope — Duarte
- University of California San Diego — San Diego
- Sarcoma Oncology Center — Santa Monica
Florida
- Mayo Clinic — Jacksonville
- Florida Cancer Specialists and Research Institute — Lake Mary
Illinois
- Northwestern University — Chicago
- University of Chicago — Chicago
New York
- Hematology Oncology Associates of Central New York — East Syracuse
- Weill Cornell Medicine — New York
North Carolina
- Levine Cancer Center — Charlotte
- Duke University Cancer Institute — Durham
Texas
- MD Anderson Cancer Center — Houston
- NEXT Oncology — San Antonio
Arizona
- Mayo Clinic — Scottsdale
Colorado
- Sarah Cannon Research Institute — Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2022-10-31 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05585320
The ClinicalTrials.gov registry entry for NCT05585320 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 209 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Immuneering Corporation, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 5 interventions — of which IMM-1-104 Monotherapy (Treatment Group A) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05585320 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05585320 about?
NCT05585320 is a clinical study titled "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...
What is the current status of trial NCT05585320?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 209 participants. The study started on 2022-10-31. Estimated completion is 2027-06.
What conditions does trial NCT05585320 study?
This clinical trial studies the following conditions: Advanced Solid Tumor, Pancreatic Adenocarcinoma, Non-small Cell Lung Cancer (NSCLC), Malignant Melanoma (Cutaneous). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05585320?
The interventions under investigation include: 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) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05585320?
This trial is sponsored by Immuneering Corporation, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05585320 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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