A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors
- Conditions
- Advanced Solid TumorPancreatic AdenocarcinomaMalignant Melanoma (Cutaneous)Non-small Cell Lung Cancer (NSCLC)
- Registration Number
- NCT05585320
- Lead Sponsor
- Immuneering Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Must be =18 years of age<br><br> - Must have histologically or cytologically confirmed diagnosis as follows:<br><br> 1. Monotherapy Phase 1: A locally advanced unresectable or metastatic solid tumor<br> malignancy that harbors a RAS (KRAS, NRAS, or HRAS) activating mutation.<br><br> 2. Monotherapy Phase 2a: A locally advanced unresectable or metastatic solid tumor<br> malignancies: pancreatic ductal adenocarcinoma (PDAC), RAS-mutant melanoma, or<br> RAS-mutant non-small cell lung cancer (NSCLC)<br><br> 3. Combination therapy (both phases): A locally advanced unresectable or<br> metastatic PDAC<br><br> - Participants must be treatment naive or received prior systemic standard-of-care<br> treatment as follows:<br><br> 1. Monotherapy Phase 1: received at least 1 line of systemic standard-of-care<br> treatment for their advanced or metastatic disease<br><br> 2. Monotherapy Phase 2a:<br><br> 1. First-line PDAC participants will have received no previous systemic<br> anti-cancer therapy. Second-line PDAC participants will have received no<br> more than one prior systemic anti-cancer therapy.<br><br> 2. First-line melanoma participants will have received no previous systemic<br> anti-cancer therapy. Second- and third-line participants will have<br> received and failed one or two prior systemic anti-cancer therapies,<br> respectively.<br><br> 3. NSCLC participants will have received at least one and no more than two<br> previous lines of systemic therapy.<br><br> 3. Combination therapy (both phases): PDAC participants will have received no<br> previous systemic anti-cancer therapy for their advanced or metastatic disease.<br><br> - Must have evidence of measurable disease (at least one target lesion) per RECIST<br> v1.1 criteria<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1<br><br> - Adequate organ function<br><br>Exclusion Criteria:<br><br> - Inability to swallow oral medications<br><br> - Symptomatic, untreated, or actively progressing known central nervous system (CNS)<br> metastases<br><br> - History or concurrent evidence of retinal vein occlusion (RVO) or current risk<br> factors for RVO. History of serous retinopathy, retinal edema, or retinal pigment<br> epithelial detachment (RPED)<br><br> - Impaired cardiovascular function or clinically significant cardiac disease<br><br> - History of rhabdomyolysis within 3 months prior to start of study treatment<br><br> - Active skin disorder requiring systemic treatment within 3 months prior to the start<br> of study treatment<br><br> - Females who are pregnant, breastfeeding, or planning to become pregnant and males<br> who plan to father a child while enrolled in this study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1: Adverse Events;Phase 1: Dose-Limiting Toxicities;Phase 1: Recommended Phase 2 Dose (RP2D) candidate;Phase 2a: Overall Response Rate
- Secondary Outcome Measures
Name Time Method Phase 1/2a: Maximum Observed Plasma Concentration of IMM-1-104;Phase 1/2a: Time to Reach Maximum Plasma Concentration of IMM-1-104;Phase 1/2a: Area Under Plasma Concentration (AUC) Time Curve of IMM-1-104;Phase 2a: Disease Control Rate (DCR);Phase 2a: Progression Free Survival (PFS);Phase 2a: Duration of Response (DOR);Phase 2a: Landmark 3-Month Survival;Phase 2a: Landmark 6-Month Survival;Phase 2a: Overall Survival (OS)