臨床研究等提出・公開システム

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

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

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Recruiting

June. 15, 2026

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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

- 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

Both

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

MK-4884

DLT
AE(s)
Discontinuing study intervention due to an AE(s)

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

+81-3-3542-2511

June. 12, 2026

Yes

https://engagezone.msd.com/

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