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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor, Pancreatic Adenocarcinoma, Malignant Melanoma (Cutaneous), Non-small Cell Lung Cancer (NSCLC)

In brief

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.

Key facts

Study ID: NCT05585320
Run by: Immuneering Corporation
People needed: 209
Starts: 2022-10-31
Expected to finish: 2027-06-01
Last updated by the study team: 2025-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 tumor malignancy that harbors a RAS (KRAS, NRAS, or HRAS) activating mutation.
Monotherapy Phase 2a: A locally advanced unresectable or metastatic solid tumor malignancies: pancreatic ductal adenocarcinoma (PDAC), RAS-mutant melanoma, or RAS-mutant non-small cell lung cancer (NSCLC)
Combination therapy (both phases): A locally advanced unresectable or metastatic PDAC
Combination therapy Phase 2a, Treatment D: Second and third line participants with unresectable stage III or stage IV cutaneous melanoma with BRAF mutation. Must have progressed on or after treatment with an anti-PD-(L)1 monoclonal antibody as the most recent therapy. First day of study treatment must be more than 28 days but less than 12 weeks from the last dose of anti-PD-(L)1 mAb.
Combination therapy Phase 2a, Treatment E: Second and third line participants with unresectable stage III or stage IV cutaneous melanoma. Must have progressed on or after treatment with an anti-PD-(L)1 monoclonal antibody as the most recent therapy. First day of study treatment must be more than 28 days but less than 12 weeks from the last dose of anti-PD-(L)1 mAb.
Participants must be treatment naive or received prior systemic standard-of-care treatment as follows:
Monotherapy Phase 1: received at least 1 line of systemic standard-of-care treatment for their advanced or metastatic disease
Monotherapy Phase 2a:
First-line PDAC participants will have received no previous systemic anti-cancer therapy. Second-line PDAC participants will have received no more than one prior systemic anti-cancer therapy.
First-line melanoma participants will have received no previous systemic anti-cancer therapy. Second- and third-line participants will have received and failed one or two prior systemic anti-cancer therapies, respectively.
NSCLC participants will have received at least one and no more than two previous lines of systemic therapy.
Combination therapy (both phases): PDAC participants will have received no previous systemic anti-cancer therapy for their advanced or metastatic disease.
Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function

You may not qualify if…

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 risk factors for RVO. History of serous retinopathy, retinal edema, or retinal pigment epithelial 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 start of study treatment
Participants with active, uncontrolled autoimmune disease or participants actively being treated with tumor necrosis factor-alpha (TNF-alpha) inhibitors for management of their autoimmune disease are excluded
Receipt of an allogeneic tissue/solid organ transplant
Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.

Where it is running

Mayo Clinic — Scottsdale, Arizona, United States
City of Hope — Duarte, California, United States
University of California San Diego — San Diego, California, United States
Sarcoma Oncology Center — Santa Monica, California, United States
Sarah Cannon Research Institute — Denver, Colorado, United States
Mayo Clinic — Jacksonville, Florida, United States
Florida Cancer Specialists and Research Institute — Lake Mary, Florida, United States
Northwestern University — Chicago, Illinois, United States
University of Chicago — Chicago, Illinois, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
Mayo Clinic — Rochester, Minnesota, United States
Hematology Oncology Associates of Central New York — East Syracuse, New York, United States
Weill Cornell Medicine — New York, New York, United States
Levine Cancer Center — Charlotte, North Carolina, United States
Duke University Cancer Institute — Durham, North Carolina, United States
SCRI Oncology Partners — Nashville, Tennessee, United States
MD Anderson Cancer Center — Houston, Texas, United States
NEXT Oncology — San Antonio, Texas, United States
NEXT Oncology — Fairfax, Virginia, United States
University of Wisconsin Clinical Science Center — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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