Melanoma Clinical Trial
A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors
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.
Must be â‰¥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
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function
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.
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There are 5 Locations for this study
Duarte California, 91010, United States More Info
New York New York, 10021, United States More Info
Houston Texas, 77030, United States More Info
San Antonio Texas, 78229, United States More Info
Fairfax Virginia, 22031, United States More Info
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