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About
The purpose of this study is to evaluate the safety and preliminary efficacy of MK-1697. There are 2 parts in this study: dose escalation to determine the recommended phase 2 dose (RP2D) and confirm the RP2D (Part A) and cohort expansion to determine preliminary efficacy in participants with colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC) (Part B). No formal hypothesis testing will be done in this study.
Enrollment
Sex
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Inclusion criteria
For Part A; has a histologically- or cytologically-confirmed advanced/metastatic solid tumor and has received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit
For Part B: has 1 of the following histologically or cytologically confirmed tumor types that are anti-programmed cell death protein 1 (anti PD-1)/anti-programmed death-ligand 1 (anti PD-L1) treatment naive:
Has measurable disease by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Has an evaluable baseline tumor sample (either a recent or archival) for analysis
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Has central venous access (eg, portacath, Hickman line, or peripherally inserted central catheter [PICC] line) currently inserted or be considered medically fit for and willing to undergo the insertion of such a device
Is not pregnant or breastfeeding
Female participants of childbearing potential must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment
Male participants must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
22 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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