A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors

Completed · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor (Phase 1), Pancreas Adenocarcinoma, Non-small Cell Lung Cancer, Malignant Melanoma (Cutaneous)

In brief

This is a FIH, ascending dose study to characterize the safety, tolerability, optimal dose and preliminary anti-tumor activity of IMM-6-415 in participants with advanced or metastatic solid tumors harboring RAS or RAF oncogenic mutations.

Key facts

Study ID

NCT06208124

Run by

Immuneering Corporation

People needed

30

Starts

2024-02-27

Expected to finish

2025-04-30

Last updated by the study team

2025-05-28

Who can join

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

You may qualify if…

• Age ≥18 years
• Life expectancy >16 weeks
• Part 1: Histologically or cytologically confirmed diagnosis of a locally advanced unresectable or metastatic solid tumor malignancy harboring RAS (NRAS, KRAS, or HRAS)- or RAF- (ARAF, BRAF, RAF1) activating mutations, as documented by genomic analysis. Results of mutation analysis must be available prior to participant enrollment. A prior genomics report from archival tissues or liquid biopsy demonstrating mutation is acceptable
• Part 2: Histologically or cytologically confirmed diagnosis of one of the following locally advanced unresectable or metastatic solid tumor malignancies: pancreatic adenocarcinoma, RASmut melanoma, Class I BRAFmut melanoma, RASmut NSCLC, other RASmut GI cancers (aside from CRC) or any other RAFmut solid tumor as documented by genomic analysis. Results of mutation analysis must be available prior to participant enrollment. A prior genomics report from archival tissues or liquid biopsy demonstrating mutation is acceptable
• Participants must have received at least 1 line of systemic standard-of-care treatment for their advanced or metastatic disease and in the assessment of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from other treatment options
• Participants previously treated with codon-specific inhibitors of KRAS (including investigational agents) are eligible
• KRASG12C mutant participants must have received prior treatment with a KRASG12C inhibitor for any approved indication
• Radiologic evidence of measurable disease (i.e., at least 1 target lesion) according to RECIST 1.1 criteria
• ECOG performance status 0 or 1.
• Participant has adequate organ function

You may not qualify if…

• Inability to swallow oral medications.
• Symptomatic, untreated, or actively progressing known central nervous system metastases.
• Uncontrolled pleural or pericardial effusion or ascites requiring repeated drainage more than once every 28 days. In dwelling catheters are allowed.
• History of severe COVID-19 infection resulting in current need of supplemental O2 therapy to maintain resting oxygen saturations ≥90%.
• Presence of ongoing toxicities related to prior anticancer therapy that have not resolved to Grade ≤1 and are not otherwise allowed
• Impaired cardiac function or clinically significant cardiac disease
• Uncontrolled intercurrent illness including but not limited to poorly controlled diabetes or any medical condition determined by the Investigator to be a risk
• History or concurrent evidence of retinal vein occlusion (RVO) or current risk factors for RVO. History of clinically significant serous retinopathy, central serous chorioretinopathy or retinal edema.
• History of rhabdomyolysis within 3 months prior to Study Day 1
• HIV-infected participant must be on anti-retroviral therapy and have a well-controlled HIV infection/disease
• Participants with a history of HBV infection no longer requiring treatment are eligible; participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.
• 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

• Honor Health Research Institute — Scottsdale, Arizona, United States
• City of Hope — Duarte, California, United States
• Sarah Cannon Research Institute — Denver, Colorado, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.