A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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
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
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).
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.
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.
Eligibility
Primary outcome measure(s)
- Phase 1: Adverse Events — From treatment initiation through 30 days following the last IMM-1-104 dose
Number of participants with adverse events - Phase 1: Dose-Limiting Toxicities — The first 21 days of study treatment
Number of participants with dose-limiting toxicities - Phase 1: Recommended Phase 2 Candidate Optimal Dose — Initiation of study treatment through 21 days (up to approximately 18 months)
Selection of candidate optimal dose to take forward into Ph2a - Phase 2a: Overall Response Rate — After up to 48 weeks (12 cycles) of study treatment
The proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR), based on RECIST 1.1 criteria
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | |
| City of Hope | Duarte | California | |
| University of California San Diego | San Diego | California | |
| Sarcoma Oncology Center | Santa Monica | California | |
| Sarah Cannon Research Institute | Denver | Colorado | |
| Mayo Clinic | Jacksonville | Florida | |
| Florida Cancer Specialists and Research Institute | Lake Mary | Florida | |
| Northwestern University | Chicago | Illinois | |
| University of Chicago | Chicago | Illinois | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Mayo Clinic | Rochester | Minnesota | |
| Hematology Oncology Associates of Central New York | East Syracuse | New York | |
| Weill Cornell Medicine | New York | New York | |
| Levine Cancer Center | Charlotte | North Carolina | |
| Duke University Cancer Institute | Durham | North Carolina | |
| SCRI Oncology Partners | Nashville | Tennessee | |
| MD Anderson Cancer Center | Houston | Texas | |
| NEXT Oncology | San Antonio | Texas | |
| NEXT Oncology | Fairfax | Virginia | |
| University of Wisconsin Clinical Science Center | Madison | Wisconsin |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05585320 on ClinicalTrials.gov ↗ ← All trials in the USA