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NCT05585320 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors
A Phase 1 study of Advanced Solid Tumor and Pancreatic Adenocarcinoma, sponsored by Immuneering Corporation.
- Active
- Registry status
- Phase 1
- Development phase
- 209
- Enrollment target
- 20
- Study locations
NCT05585320: Active Phase 1 study of Advanced Solid Tumor and Pancreatic Adenocarcinoma, sponsored by Immuneering Corporation.
NCT05585320 is a Phase 1 study of Advanced Solid Tumor and Pancreatic Adenocarcinoma that is active but no longer recruiting, run by Immuneering Corporation. The registered enrollment target is 209 participants, roughly in line with the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05585320, a Phase 1 study of Advanced Solid Tumor and Pancreatic Adenocarcinoma, is active but no longer recruiting, sponsored by Immuneering Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 209 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Number of participants with adverse events
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 |
What the registry record for NCT05585320 still lists
NCT05585320 is an interventional study that assigns participants to a tested intervention. The registered 209 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target.
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.
NCT05585320 names 20 study sites across 13 states, led by California, Florida, Illinois.
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).
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).
Who is sponsoring clinical trial NCT05585320?
This trial is sponsored by Immuneering Corporation, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05585320's enrollment target sits among peer trials
209 63rd of 189 higher than 127 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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