A Phase 1 Study of MK-4884 for Advanced/Metastatic Solid Tumors

A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of MK-4884 in Participants with Advanced/Metastatic Solid Tumors

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031260123

Enrollment

Registered

2026-05-11

Start date

2026-06-15

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced/metastatic solid tumors (CRC, RCC, NSCLC, BTC)

Interventions

MK-4884

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

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

Design outcomes

Primary

Measure	Time frame
DLT AE(s) Discontinuing study intervention due to an AE(s)	—

Secondary

Measure	Time frame
Plasma PK parameters of MK-4884 (AUC, Cmax, Ctrough, Tmax, t1/2)	—

Countries

Canada, Israel, Japan, Switzerland, United States

Contacts

Public ContactMSDJRCT inquiry mailbox

MSD K.K.

msdjrct@msd.com+81-3-6272-1957

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026