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Trial Title: Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)

NCT ID: NCT05853367

Condition: Metastatic Solid Tumors
Advanced Solid Tumors

Conditions: Official terms:
Neoplasms
Pembrolizumab

Conditions: Keywords:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Src Homology-2 Domain Containing Protein Tyrosine Phosphatase-2 (SHP-2)

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: MK-0472
Description: Oral Administration
Arm group label: MK-0472
Arm group label: MK-0472 + MK-1084
Arm group label: MK-0472 + Pembrolizumab

Intervention type: Biological
Intervention name: Pembrolizumab
Description: IV infusion
Arm group label: MK-0472 + Pembrolizumab

Other name: MK-3475

Other name: Keytruda®

Intervention type: Drug
Intervention name: MK-1084
Description: Oral Administration
Arm group label: MK-0472 + MK-1084

Summary: The purpose of this study is to assess the efficacy, safety, and tolerability of MK-0472 administered as monotherapy and in combination with pembrolizumab (MK-3475) or MK-1084 in participants with histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumors.

Criteria for eligibility:
Criteria:
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: - Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report with oncogenic receptor tyrosine kinase (RTK) pathway alterations confirmed by a historical report or local testing and have received, or been intolerant to, all available treatment known to confer clinical benefit - Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to study enrollment - Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening - Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable (>4 weeks) antiretroviral therapy (ART) - For Arm 3 Only: Has histologically OR blood-based confirmation of KRAS G12C mutation Exclusion Criteria: The main exclusion criteria include but are not limited to the following: - Has not recovered to common terminology criteria for adverse events (CTCAE) Grade 1 or better from any adverse events that were due to cancer therapeutics administered more than 4 weeks earlier. Participants receiving ongoing replacement hormone therapy for endocrine immune-related AEs will not be excluded from participation in this study - Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years - History of hyperparathyroidism or hypercalcemia - Has one or more of the following ophthalmological findings/conditions: a) Intraocular pressure >21 mm Hg and/or any diagnosis of glaucoma b) Diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and c) Diagnosis of retinal degenerative disease - Has clinically significant cardiovascular disease - Bullous exfoliative skin disorders of any grade - Known hypersensitivity to MK-0472, MK-1084, or pembrolizumab, or any of their excipients - Received therapy with a proton-pump inhibitor or an H2 histamine blocker receptor antagonist within 7 days before the first scheduled day of study dosing - Has discontinued prior therapy with an anti-programmed cell death-1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor due to an adverse event - Received prior systemic anticancer therapy including investigational agents within 4 weeks before first dose - Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention - Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration - Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication - Has known additional malignancy that is progressing or has required active treatment within the past 2 years - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention - Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy - Has history of pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - Has active infection requiring systemic therapy - Has history of allogeneic tissue/solid organ transplant - Have not adequately recovered from major surgery or have ongoing surgical complications

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Northwestern Memorial Hospital ( Site 0002)

Address:
City: Chicago
Zip: 60611
Country: United States

Status: Recruiting