A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors
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Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
209actual
Sites
20
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-10-31 | actual | When the study began enrolling |
| Primary completion | Jun 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-10-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-09-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced Solid Tumor
- Pancreatic Adenocarcinoma
- Malignant Melanoma (Cutaneous)
- Non-small Cell Lung Cancer (NSCLC)
Interventions
- Drug: IMM-1-104 Monotherapy (Treatment Group A) — also filed as IMM-1-104
- Drug: IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B) — also filed as IMM-1-104 + mGnP
- Drug: IMM-1-104 + modified FOLFIRINOX (Treatment Group C) — also filed as IMM-1-104 + mFFX
- Drug: IMM-1-104 + dabrafenib (Treatment Group D) — also filed as IMM-1-104 + dabrafenib
- Drug: IMM-1-104 + pembrolizumab (Treatment Group E) — also filed as IMM-1-104 + pembro
Primary outcomes
what the primary-completion date above is the date OFPhase 1: Adverse Events
measured From treatment initiation through 30 days following the last IMM-1-104 dose
Phase 1: Dose-Limiting Toxicities
measured The first 21 days of study treatment
Phase 1: Recommended Phase 2 Candidate Optimal Dose
measured Initiation of study treatment through 21 days (up to approximately 18 months)
Phase 2a: Overall Response Rate
measured After up to 48 weeks (12 cycles) of study treatment
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