Clinical trial · Interventional
Clinical Study of MK-4884 in Participants With Advanced or Metastatic Solid Tumors (MK-4884-001)
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
NCT07600749CI-TRIAL-00125702recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MK-4884 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MK-4884 Dose Escalation Schedule A
- description
- Participants will receive MK-4884 at varying dose levels until any of the criteria for discontinuation of the study intervention are met.
- interventionNames
- Drug: MK-4884
- type
- EXPERIMENTAL
- label
- MK-4884 Dose Escalation Schedule B
- description
- Participants will receive MK-4884 at varying dose levels until any of the criteria for discontinuation of the study intervention are met.
- interventionNames
- Drug: MK-4884
Primary outcomes (3)
- measure
- Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.