A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: All

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 in participants with RAS-mutated advanced or metastatic solid tumors. The dose exploration will identify the candidate recommended Phase 2 dose (RP2D) of IMM-1-104 to further explore the anti-tumor activity of IMM-1-104 as monotherapy in 4 Phase 2a tumor-specific cohorts.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immuneering Corporation

Criteria

Inclusion Criteria:

• Must be ≥18 years of age

• Phase 1: Must have histologically or cytologically confirmed RAS-mutated (KRAS, NRAS, or HRAS) solid tumor malignancy that is advanced and unresectable, or metastatic.

• Phase 2a: Must have histologically or cytologically confirmed diagnosis of one of the following locally advanced unresectable or metastatic solid tumor malignancies: NRAS-mutant melanoma, KRAS-mutant pancreatic ductal adenocarcinoma (PDAC), KRAS-mutant non-small cell lung cancer (NSCLC), or KRAS-mutant and APC-wild-type colorectal cancer (CRC)

• Must have received at least one prior systemic, standard-of-care therapy to treat their advanced or metastatic disease

• Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria

• ECOG performance status of 0 or 1

• Adequate organ function

Exclusion Criteria:

• 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

• Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.