The main purpose of this study is to characterize safety and to determine the recommended phase 2 dose (RP2D) for JNJ-88998377 (Part A: Dose Escalation), to further assess the safety of JNJ-88998377 at the RP2D (Part B: Dose Expansion).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
JNJ-88998377 will be administered.
Beijing Cancer Hospital
Beijing, China
Sun Yat Sen University Cancer Center
Guangzhou, China
Parts A and B: Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product.
Time frame: Upto 3 years 4 months
Part A: Number of Participants with Dose Limiting Toxicity (DLTs)
Number of participant with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematological or hematological toxicity.
Time frame: Cycle 1 (21 days)
Plasma Concentration of JNJ-88998377
Plasma concentration of oral dose of JNJ-88998377 will be assessed.
Time frame: Up to first 12 weeks
Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (τ) At Steady-State of JNJ-88998377
Area under the plasma concentration versus time curve during a dosing interval (τ) at steady-state concentration of JNJ-88998377 will be reported.
Time frame: Up to first 12 weeks
Maximum Plasma Concentration (Cmax) of JNJ-88998377
Cmax of JNJ-88998377 will be reported.
Time frame: Up to first 12 weeks
Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377
Cmin of JNJ-88998377 will be reported.
Time frame: Up to first 12 weeks
Percentage of Participants With Overall Response (OR)
OR is defined as the percentage of participants who have a best response of partial response (PR) or better per investigator assessment according to disease-specific response criteria.
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The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, China
Fudan University Shanghai Cancer Center
Shanghai, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
A O U Sant Orsola Malpighi
Bologna, Italy
National Cancer Center Hospital
Chūōku, Japan
National Cancer Center Hospital East
Kashiwa, Japan
The Cancer Institute Hospital of JFCR
Tokyo, Japan
Pratia Onkologia Katowice
Katowice, Poland
...and 9 more locations
Time frame: Up to 3 years 4 months
Time to Response (TTR)
TTR is defined for participants who achieved a response of PR or better as the time from the first dose of study treatment to the first response of PR or better per investigator assessment according to disease-specific response criteria.
Time frame: From first dose of study treatment until first response of PR or better (up to 3 years and 4 months)
Duration of Response (DOR)
DOR is defined for participants who achieved a response of PR or better as the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death.
Time frame: From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months)