ACTIVE_NOT_RECRUITING

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

Talk to us

Conditions

Advanced Solid TumorPancreatic AdenocarcinomaMalignant Melanoma (Cutaneous)Non-small Cell Lung Cancer (NSCLC)pan-RASKRASNRASHRASTargeted therapyMetastatic cancerAdvanced cancerRASAdenocarcinomaMEKDual MEKMEK 1/2Mitogen-Activated Protein Kinase (MAPK)G12AG12CG12DG12FG12RG12SG12VG13CG13DG13RQ61HQ61KQ61LQ61RA146TA146VK117N

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-31
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05585320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must be ≥18 years of age
  2. * Must have histologically or cytologically confirmed diagnosis as follows:
  3. 1. Monotherapy Phase 1: A locally advanced unresectable or metastatic solid tumor malignancy that harbors a RAS (KRAS, NRAS, or HRAS) activating mutation.
  4. 2. 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)
  5. 3. Combination therapy (both phases): A locally advanced unresectable or metastatic PDAC
  6. 4. 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.
  7. 5. 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.
  8. * Participants must be treatment naive or received prior systemic standard-of-care treatment as follows:
  9. 1. Monotherapy Phase 1: received at least 1 line of systemic standard-of-care treatment for their advanced or metastatic disease
  10. 2. Monotherapy Phase 2a:
  11. 1. 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.
  12. 2. 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.
  13. 3. NSCLC participants will have received at least one and no more than two previous lines of systemic therapy.
  14. 3. Combination therapy (both phases): PDAC participants will have received no previous systemic anti-cancer therapy for their advanced or metastatic disease.
  15. * Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria
  16. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  17. * Adequate organ function
  1. * Inability to swallow oral medications
  2. * Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases
  3. * 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)
  4. * Impaired cardiovascular function or clinically significant cardiac disease
  5. * History of rhabdomyolysis within 3 months prior to start of study treatment
  6. * Active skin disorder requiring systemic treatment within 3 months prior to the start of study treatment
  7. * 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
  8. * Receipt of an allogeneic tissue/solid organ transplant
  9. * Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.

Contacts and Locations

Principal Investigator

Vinny Hayreh, MD
STUDY_DIRECTOR
Immuneering Corporation

Study Locations (Sites)

Mayo Clinic
Scottsdale, Arizona, 85259
United States
City of Hope
Duarte, California, 91010
United States
University of California San Diego
San Diego, California, 92037
United States
Sarcoma Oncology Center
Santa Monica, California, 90403
United States
Sarah Cannon Research Institute
Denver, Colorado, 80218
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Florida Cancer Specialists and Research Institute
Lake Mary, Florida, 32746
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Chicago
Chicago, Illinois, 60637
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Hematology Oncology Associates of Central New York
East Syracuse, New York, 13057
United States
Weill Cornell Medicine
New York, New York, 10021
United States
Levine Cancer Center
Charlotte, North Carolina, 28204
United States
Duke University Cancer Institute
Durham, North Carolina, 27710
United States
SCRI Oncology Partners
Nashville, Tennessee, 27203
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
NEXT Oncology
San Antonio, Texas, 78229
United States
NEXT Oncology
Fairfax, Virginia, 22031
United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Immuneering Corporation

  • Vinny Hayreh, MD, STUDY_DIRECTOR, Immuneering Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-31
Study Completion Date2027-06

Study Record Updates

Study Start Date2022-10-31
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • pan-RAS
  • KRAS
  • NRAS
  • HRAS
  • Targeted therapy
  • Metastatic cancer
  • Advanced cancer
  • RAS
  • Adenocarcinoma
  • MEK
  • Dual MEK
  • MEK 1/2
  • Mitogen-Activated Protein Kinase (MAPK)
  • G12A
  • G12C
  • G12D
  • G12F
  • G12R
  • G12S
  • G12V
  • G13C
  • G13D
  • G13R
  • Q61H
  • Q61K
  • Q61L
  • Q61R
  • A146T
  • A146V
  • K117N

Additional Relevant MeSH Terms

  • Advanced Solid Tumor
  • Pancreatic Adenocarcinoma
  • Malignant Melanoma (Cutaneous)
  • Non-small Cell Lung Cancer (NSCLC)