Clinical Study of MK-4884 in Participants With Advanced or Metastatic Solid Tumors (MK-4884-001)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Malignant Neoplasm

Treatments: Drug: MK-4884

Study type: Interventional

Funder types: Industry

Identifiers

NCT07600749

4884-001

Details and patient eligibility

About

Researchers are looking for new ways to treat certain types of advanced and/or metastatic solid tumors.

The main goal of this study is to learn about the safety of different doses of MK-4884 and if participants tolerate them.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a histologically or cytologically confirmed diagnosis of 1 of the following unresectable (locally advanced) and/or advanced (metastatic) solid tumors:
• Colorectal carcinoma (CRC)
• Renal cell carcinoma (RCC) that contains a clear cell component (with or without sarcomatoid and/or rhabdoid features)
• Nonsquamous non-small cell lung cancer (NSCLC)
• Biliary tract cancer (BTC) (intra-or extrahepatic cholangiocarcinoma (CCA)) or gallbladder cancer (GBC)
• Has measurable disease by Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1)
• Has adequate organ function
• Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable antiretroviral therapy (ART) for at least 4 weeks
• Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
• Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion criteria

• Has gastrointestinal malabsorption, a surgical procedure or a condition that could affect the absorption of the study drug
• Has a history of clinically significant cardiac, cardiovascular and/or cerebrovascular disease
• Has a serious nonhealing wound, ulcer, or bone fracture
• Has an active infection(s) requiring systemic therapy
• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• 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
• Has a history of stem cell/solid organ transplant
• Has not adequately recovered from major surgery

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

MK-4884 Dose Escalation Schedule A

Experimental group

Description:

Participants will receive MK-4884 at varying dose levels until any of the criteria for discontinuation of the study intervention are met.

Treatment:

Drug: MK-4884

MK-4884 Dose Escalation Schedule B

Experimental group

Description:

Participants will receive MK-4884 at varying dose levels until any of the criteria for discontinuation of the study intervention are met.

Treatment:

Drug: MK-4884