Phase
Condition
Melanoma
Pancreatitis
Pancreatic Cancer
Treatment
IMM-1-104 Monotherapy (Treatment Group A)
IMM-1-104 + modified FOLFIRINOX (Treatment Group C)
IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must be ≥18 years of age
Must have histologically or cytologically confirmed diagnosis as follows:
Monotherapy Phase 1: A locally advanced unresectable or metastatic solid tumormalignancy that harbors a RAS (KRAS, NRAS, or HRAS) activating mutation.
Monotherapy Phase 2a: A locally advanced unresectable or metastatic solid tumormalignancies: pancreatic ductal adenocarcinoma (PDAC), RAS-mutant melanoma, orRAS-mutant non-small cell lung cancer (NSCLC)
Combination therapy (both phases): A locally advanced unresectable ormetastatic PDAC
- Participants must be treatment naive or received prior systemic standard-of-caretreatment as follows:
Monotherapy Phase 1: received at least 1 line of systemic standard-of-caretreatment for their advanced or metastatic disease
Monotherapy Phase 2a:
First-line PDAC participants will have received no previous systemicanti-cancer therapy. Second-line PDAC participants will have received nomore than one prior systemic anti-cancer therapy.
First-line melanoma participants will have received no previous systemicanti-cancer therapy. Second- and third-line participants will havereceived and failed one or two prior systemic anti-cancer therapies,respectively.
NSCLC participants will have received at least one and no more than twoprevious lines of systemic therapy.
Combination therapy (both phases): PDAC participants will have received noprevious systemic anti-cancer therapy for their advanced or metastatic disease.
Must have evidence of measurable disease (at least one target lesion) per RECISTv1.1 criteria
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function
Exclusion
Exclusion Criteria:
Inability to swallow oral medications
Symptomatic, untreated, or actively progressing known central nervous system (CNS)metastases
History or concurrent evidence of retinal vein occlusion (RVO) or current riskfactors for RVO. History of serous retinopathy, retinal edema, or retinal pigmentepithelial detachment (RPED)
Impaired cardiovascular function or clinically significant cardiac disease
History of rhabdomyolysis within 3 months prior to start of study treatment
Active skin disorder requiring systemic treatment within 3 months prior to the startof study treatment
Females who are pregnant, breastfeeding, or planning to become pregnant and maleswho plan to father a child while enrolled in this study.
Study Design
Connect with a study center
Mayo Clinic
Scottsdale, Arizona 85259
United StatesActive - Recruiting
City of Hope
Duarte, California 91010
United StatesActive - Recruiting
University of California San Diego
San Diego, California 92037
United StatesActive - Recruiting
Sarcoma Oncology Center
Santa Monica, California 90403
United StatesActive - Recruiting
Sarah Cannon Research Institute
Denver, Colorado 80218
United StatesActive - Recruiting
Mayo Clinic
Jacksonville, Florida 32224
United StatesActive - Recruiting
Florida Cancer Specialists and Research Institute
Lake Mary, Florida 32746
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesActive - Recruiting
University of Chicago
Chicago, Illinois 60637
United StatesActive - Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
Hematology Oncology Associates of Central New York
East Syracuse, New York 13057
United StatesActive - Recruiting
Weill Cornell Medicine
New York, New York 10021
United StatesActive - Recruiting
Levine Cancer Center
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Duke University Cancer Institute
Durham, North Carolina 27710
United StatesActive - Recruiting
SCRI Oncology Partners
Nashville, Tennessee 27203
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
NEXT Oncology
San Antonio, Texas 78229
United StatesSite Not Available
NEXT Oncology
Fairfax, Virginia 22031
United StatesActive - Recruiting
University of Wisconsin Clinical Science Center
Madison, Wisconsin 53792
United StatesActive - Recruiting
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