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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

209

Participants

Timeline

Start Date

October 31, 2022

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2027

Conditions
Advanced Solid TumorPancreatic AdenocarcinomaMalignant Melanoma (Cutaneous)Non-small Cell Lung Cancer (NSCLC)
Interventions
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.

Trial Locations (20)

10021

Weill Cornell Medicine, New York

13057

Hematology Oncology Associates of Central New York, East Syracuse

22031

NEXT Oncology, Fairfax

27203

SCRI Oncology Partners, Nashville

27710

Duke University Cancer Institute, Durham

28204

Levine Cancer Center, Charlotte

32224

Mayo Clinic, Jacksonville

32746

Florida Cancer Specialists and Research Institute, Lake Mary

53792

University of Wisconsin Clinical Science Center, Madison

55905

Mayo Clinic, Rochester

60611

Northwestern University, Chicago

60637

University of Chicago, Chicago

77030

MD Anderson Cancer Center, Houston

78229

NEXT Oncology, San Antonio

80218

Sarah Cannon Research Institute, Denver

85259

Mayo Clinic, Scottsdale

90403

Sarcoma Oncology Center, Santa Monica

91010

City of Hope, Duarte

92037

University of California San Diego, San Diego

02215

Dana Farber Cancer Institute, Boston

All Listed Sponsors
lead

Immuneering Corporation

INDUSTRY