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

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Jun 2026 → Jun 2027
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Record History

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  1. Primary completion pushed from Jun 2026 to Jun 2027 Show 4 more changesShow less
    • Study completion pushed from Jun 2027 to Jun 2028
    • Interventions: IMM-1-104 + dabrafenib (Treatment Group D) (Drug), IMM-1-104 + modified FOLFIRINOX (Treatment Group C) (Drug), IMM-1-104 + modified… to IMM-1-104 + dabrafenib (Treatment Group D) (Drug), IMM-1-104 + modified FOLFIRINOX (Treatment Group C) (Drug), IMM-1-104 + modified…
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 3 of 9 entries
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 320 to confirmed 209
    • Site details revised at 20 of 20 sites
    v30
  3. Enrollment target: 210 to 320v29 Show 5 more changesShow less
    • Primary endpoints revised (4)
    • Interventions: IMM-1-104 + modified FOLFIRINOX (Treatment Group C) (Drug), IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B) (Drug)… to IMM-1-104 + dabrafenib (Treatment Group D) (Drug), IMM-1-104 + modified FOLFIRINOX (Treatment Group C) (Drug), IMM-1-104 + modified…
    • Eligibility criteria expanded, about 155 words
    • Study arms: 3 to 5
    • Study title shortened, about 3 words
  4. Study sites: 19 to 20v28
  5. Study sites: 18 to 19v27
Show 25 earlier versionsHide 25 earlier versions
  1. Study sites: 15 to 18v26
  2. Study sites: 14 to 15v25
  3. Site details revised at 1 of 14 sitesv24
  4. Study sites: 13 to 14v23
  5. Site details revised at 1 of 13 sitesv22
  6. Study sites: 11 to 13v21
  7. Site details revised at 1 of 11 sitesv20
  8. Study sites: 8 to 11v19
  9. Study sites revised (8)v18
  10. Study sites: 7 to 8v17
  11. Site details revised at 1 of 7 sitesv16
  12. Site details revised at 1 of 7 sitesv15
  13. Study sites: 5 to 7v14
  14. Re-verified, no change to tracked fieldsv13
  15. Enrollment target: 156 to 210
    • Interventions: IMM-1-104 (Drug) to IMM-1-104 + modified FOLFIRINOX (Treatment Group C) (Drug), IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B) (Drug)…
    • Eligibility criteria expanded, about 110 words
    • Study arms: 1 to 3
    v12
  16. Site details revised at 1 of 5 sitesv11
  17. 3 versions Re-verified since Feb 14, 2023, no change to tracked fieldsv8-v10
  18. Site details revised at 1 of 5 sitesv7
  19. Site details revised at 1 of 5 sitesv6
  20. Re-verified, no change to tracked fieldsv5
  21. Start date changed from estimate of Oct 2022 to Oct 31, 2022v4
  22. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 5 of 5 sites
    v3
  23. Secondary endpoints revised (9)
    • Primary endpoints revised (4)
    • Eligibility criteria expanded, about 4 words
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Immuneering Corporation
2 trials monitored
See 1 trial at risk
Lung Cancer
4,803 trials monitored
See 272 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,087 trials monitored
See 179 trials at risk
Pancreatic Cancer
1,742 trials monitored
See 107 trials at risk
and 1 more disease
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.
Trial Details
NCT Number NCT05585320
Lead Sponsor Immuneering Corporation
Conditions
(from sponsor)		 Advanced Solid Tumor, Pancreatic Adenocarcinoma, Malignant Melanoma (Cutaneous), Non-small Cell Lung Cancer (NSCLC)
Related terms Adenocarcinoma, Carcinoma, Non-Small-Cell Lung, Cutaneous Malignant Melanoma, Neoplasm Metastasis
Enrollment 209 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov