Trials / Active Not Recruiting
Active Not RecruitingNCT05585320
A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic 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
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 209 (actual)
- Sponsor
- Immuneering Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Advanced Solid Tumor
- Pancreatic Adenocarcinoma
- Malignant Melanoma (Cutaneous)
- Non-small Cell Lung Cancer (NSCLC)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IMM-1-104 Monotherapy (Treatment Group A) | Once-daily, oral IMM-1-104 dose administered in 28-day cycles until treatment discontinuation criteria are met |
| DRUG | IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B) | Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with intravenous infusions of gemcitabine and nab-paclitaxel until treatment discontinuation criteria are met. Gemcitabine will be administered at a dose of 1000 mg/m\^2 nab-Paclitaxel will be administered at a dose of 125 mg/m\^2 |
| DRUG | IMM-1-104 + modified FOLFIRINOX (Treatment Group C) | Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with intravenous infusions of modified FOLFIRNOX until treatment discontinuation criteria are met. FOLFIRINOX will be administered as follows: Folinic Acid will be administered at 400 mg/m\^2 Fluorouracil will be administered at 2400 mg/m\^2 Irinotecan will be administered at 150 mg/m\^2 Oxaliplatin will be administered at 85 mg/m\^2 |
| DRUG | IMM-1-104 + dabrafenib (Treatment Group D) | Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with twice daily oral dose of dabrafenib until treatment discontinuation criteria are met. Dabrafenib will be administered at a dose of 150mg daily (75mg twice daily). |
| DRUG | IMM-1-104 + pembrolizumab (Treatment Group E) | Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with intravenous infusions of pembrolizumab in sequence or concurrently depending on the enrolled cohort (two sub cohorts) until treatment discontinuation criteria are met. Pembrolizumab will be administered at a dose of 400mg. |
Timeline
- Start date
- 2022-10-31
- Primary completion
- 2026-06-01
- Completion
- 2027-06-01
- First posted
- 2022-10-18
- Last updated
- 2025-09-02
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05585320. Inclusion in this directory is not an endorsement.