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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05853367
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Solid Tumors
  • Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MK-0472 — DRUG
    Oral Administration
  • Pembrolizumab — BIOLOGICAL
    IV infusion
  • MK-1084 — DRUG
    Oral Administration

Study Details

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.

Key Dates

First listed
May 10, 2023
Start date
Jul 6, 2023
Status verified
Jul 2026
Primary completion
May 26, 2028
Completion
May 26, 2028

Study Design

Enrollment
95 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MK-0472
    Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation.
  • Experimental: MK-0472 + Pembrolizumab
    Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation, plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
  • Experimental: MK-0472 + MK-1084
    Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens, plus MK-1084 via oral capsule until disease progression or withdrawal/discontinuation.

Primary Outcome Measure

Number of Participants Who Experience a Dose Limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Northwestern Memorial Hospital ( Site 0002)ChicagoIllinois60611-
The University of Louisville, James Graham Brown Cancer Center ( Site 0004)LouisvilleKentucky40202-
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)HackensackNew Jersey07601-
Rutgers Cancer Institute of New Jersey ( Site 0005)New BrunswickNew Jersey08901-

Find similar trials in Chicago, IL

By research site
Northwestern Memorial Hospital· Chicago, ILThe University of Louisville, James Graham Brown Cancer Center· Louisville, KYJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJRutgers Cancer Institute of New Jersey· New Brunswick, NJ

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