A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors
a study on Solid Tumor Pancreatic Cancer Skin Cancer/Melanoma Lung Cancer Non-Small Cell Lung Cancer
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCSD
- Dates
- study startedcompletion around
- Principal Investigator
- by Peter Vu, MD (ucsd)
Description
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.
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
Keywords
Advanced Solid Tumor, Pancreatic Adenocarcinoma, Malignant Melanoma (Cutaneous), Non-small Cell Lung Cancer (NSCLC), 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, Melanoma, Paclitaxel, Gemcitabine, Pembrolizumab, Dabrafenib, Folfirinox, IMM-1-104 Monotherapy (Treatment Group A), IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B), IMM-1-104 + modified FOLFIRINOX (Treatment Group C), IMM-1-104 + dabrafenib (Treatment Group D), IMM-1-104 + pembrolizumab (Treatment Group E)
Eligibility
You can join if…
Open to people ages 18 years and up
- 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 CAN'T join 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.
Locations
- University of California San Diego
accepting new patients
San Diego California 92037 United States - Sarcoma Oncology Center
accepting new patients
Santa Monica California 90403 United States - City of Hope
accepting new patients
Duarte California 91010 United States
Lead Scientist at University of California Health
- Peter Vu, MD (ucsd)
Associate Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 7 research publications
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Immuneering Corporation
- ID
- NCT05585320
- Phase
- Phase 1/2 research study
- Study Type
- Interventional
- Participants
- Expecting 320 study participants
- Last Updated