A Phase 1, Open-Label, Multicenter Study to Assess the Safety and Tolerability of MK-1484 as a Monotherapy and in Combination with Pembrolizumab in Participants with Advanced or Metastatic Solid Tumors
- Conditions
- Advanced or Metastatic Solid Tumors / Terminal cancer10027655
- Registration Number
- NL-OMON51516
- Lead Sponsor
- Merck Sharp & Dohme (MSD)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
# The participant has provided documented informed consent for this study.
# Male or female of at least 18 years at the time of signing the informed
consent form.
# Histologically- or cytologically-confirmed advanced/metastatic solid tumor by
pathology report and received, or intolerant to, all treatment known to confer
clinical benefit.
# Measurable disease by RECIST 1.1.
# Performance status of 0 or 1 on the ECOG Performance Scale (within 7 days
before the start of study intervention).
# Normal cardiac function based on TTE or MUGA.
# Presence of an evaluable archival or newly obtained tumor tissue sample for
biomarker analysis.
# Adequate organ function (within 7 days before the start of study
intervention).
# A male participant must agree to use contraception as detailed in the
protocol.
# A female participant is eligible to participate if not pregnant or
breastfeeding, agrees to follow the contraceptive guidance as detailed in the
protocol, or is not of child-bearing potential.
# Chemotherapy, definitive radiation or biological cancer therapy within 4
weeks (2 weeks for palliative radiation) before the first dose of study
intervention.
# Not recovered to CTCAE Grade 1 or better from any AEs that were due to cancer
therapeutics administered more than 4 weeks earlier.
# Currently participating and receiving study intervention in a study of an
investigational agent, or participated and received study intervention in a
study of an investigational agent, or used an investigational device within 28
days of administration of MK-1484.
# Received any prior IL-2 based therapy.
# Allogeneic tissue/solid organ transplant in the last 5 years or evidence of
graft-versus-host disease.
# History of a second malignancy, unless potentially curative treatment has
been completed with no evidence of malignancy for 2 years.
# Clinically active CNS metastases and/or carcinomatous meningitis (exceptions
per protocol).
# History of severe hypersensitivity reaction to treatment with a monoclonal
antibody and/or components of the study intervention(s).
# Active infection requiring therapy.
# Active autoimmune disease that required systemic treatment in the past 2
years (details per protocol).
# History of interstitial lung disease, history of (noninfectious) pneumonitis
that required steroids, or current pneumonitis.
# Known HIV and/or hepatitis B or C infections, or known to be positive for
HBsAg/HBV DNA or hepatitis C Antibody or RNA.
# History or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the study, interfere with the
participant*s participation for the full duration of the study, make
administration of the study drugs hazardous, or make it difficult to monitor
adverse effects such that it is not in the best interest of the participant to
participate, in the opinion of the treating investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Occurrence of Dose-Limiting Toxicity (DLT), Adverse Events (AE), and<br /><br>discontinuation of study intervention due to an AE.</p><br>
- Secondary Outcome Measures
Name Time Method <p>PK parameters of MK-1484, including area under the curve (AUC), minimum<br /><br>concentration (Cmin), and maximum concentration (Cmax).</p><br>