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 Previously Treated RAS-Mutated Advanced or Metastatic Solid Tumors

Description
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 Previously Treated RAS-Mutated Advanced or Metastatic Solid Tumors

Objective
Primary Objectives:

Phase 1:
-To determine the safety, tolerability, and candidate RP2D of IMM-1-104 as monotherapy and in combination with approved agents in participants with advanced RAS-mutated or RAS/MAPK pathway activated solid tumors

Phase 2a:
-To evaluate the anti-tumor activity of IMM-1-104 as monotherapy and in combination with approved agents in participants with select advanced RAS-mutated or RAS/MAPK pathway activated solid tumors

Secondary Objectives:

Phase 1:
-To characterize the PK of IMM-1-104 in participants with advanced RAS-mutated or RAS/MAPK pathway activated solid tumors, in absence and presence of approved agents

Phase 2a:
-To characterize the PK of IMM-1-104 in participants with select advanced RAS-mutated or RAS/MAPK pathway activated solid tumors
-To characterize the safety and tolerability of IMM-1-104 administered at the candidate RP2D as monotherapy and in combination with approved agents in participants with select advanced RAS-mutated or RAS/MAPK pathway activated solid tumors
-To further characterize the anti-tumor activity of IMM-1-104 as monotherapy and in combination with approved agents in participants with select advanced RAS-mutated or RAS/MAPK pathway activated solid tumors

Treatment 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 dose (RP2D) 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.

Key Eligibility For full study eligibility, see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Anal; Any Site; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital