The purpose of this study is to find out the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) of JNJ-101684362 (HLD-0117), to evaluate the safety of JNJ-101684362 (HLD-0117) , and how well the participants can tolerate it in Part 1 (dose escalation) of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
170
A treatment cycle consists of 28 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)
Yale University School Of Medicine
New Haven, Connecticut, United States
RECRUITINGFlorida Cancer Specialists
Sarasota, Florida, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
Dose Limiting Toxicities (DLTs)
Frequency of dose-limiting toxicities (DLTs)
Time frame: 28 days
AEs, ECGs, Labs and Clinical Changes
Frequency and severity of adverse events (AEs) and abnormal electrocardiogram (ECG), laboratory and clinical changes from baseline
Time frame: 28 days
Objective response rate (ORR)
Objective response rate (ORR) per RECIST in evaluable patients
Time frame: 56 Days
Duration of response (DOR)
DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first.
Time frame: 28 days
Progression-free survival (rPFS)
Radiographic progression-free survival (rPFS)
Time frame: 56 days
Disease Control Rate (DCR)
Disease Control Rate (DCR)
Time frame: 24 weeks
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of patients who achieve partial response (PR) or complete response (CR), or stable disease (SD) lasting at least 24 weeks, as assessed according to RECIST v1.1.
Time frame: 24 weeks
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SCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITINGSouth Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, United States
RECRUITINGNext Virginia
Fairfax, Virginia, United States
RECRUITING