The purpose of this study is to determine safety and recommended phase 2 dose(s) (RP2Ds) of JNJ-87890387 and to determine the safety of JNJ-87890387 at the RP2D(s).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
JNJ-87890387 will be administered.
Start Midwest
Grand Rapids, Michigan, United States
RECRUITINGSarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGCentre Leon Berard
Lyon, France
Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
Number of participants with DLTs will be reported. The DLTs are adverse events including certain high grade non-hematologic or hematologic toxicities, or toxicities meeting other specific criteria.
Time frame: Up to first 21 days after administration of the first full treatment dose
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events (ICANS), which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
Time frame: Up to 2 years 9 months
Part 1 and Part 2: Serum Concentration of JNJ-87890387
Serum concentration of JNJ-87890387 will be reported.
Time frame: Up to 2 years 9 months
Part 1 and Part 2: Maximum Observed Serum Concentration (Cmax) of JNJ-87890387
Cmax is defined as maximum observed serum concentration of JNJ-87890387.
Time frame: Up to 2 years 9 months
Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-87890387
Tmax is defined as the time to reach maximum observed serum concentration of JNJ-87890387.
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Institut Gustave Roussy
Villejuif, France
RECRUITINGHosp Univ Vall D Hebron
Barcelona, Spain
RECRUITINGHosp. Univ. 12 de Octubre
Madrid, Spain
RECRUITINGTime frame: Up to 2 years 9 months
Part 1 and Part 2: Area Under the Curve from Time t1 to Time t2 (AUC[t1-t2]) of JNJ-87890387
AUC(t1-t2) is defined as area under the serum concentration versus time curve from time t1 to time t2 of JNJ-87890387.
Time frame: Up to 2 years 9 months
Part 1 and Part 2: Area Under the Curve from Time Zero to Time tau (AUC[0-tau]) of JNJ-87890387
AUC(0-tau) is defined as area under the serum concentration versus time curve from time 0 to time tau of JNJ-87890387.
Time frame: Up to 2 years 9 months
Part 1 and Part 2: Minimum Observed Serum Concentration (Cmin) of JNJ-87890387
Cmin is defined as the minimum observed serum concentration of JNJ-87890387.
Time frame: Up to 2 years 9 months
Part 1 and Part 2: Accumulation Ratio of JNJ-87890387
Accumulation ratio of JNJ-87890387 will be reported. The AR is the accumulation ratio calculated as Cmax or AUC after multiple doses divided by Cmax or AUC after the first dose, respectively.
Time frame: Up to 2 years 9 months
Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-87890387 Antibodies
Number of participants with presence of anti-JNJ-87890387 antibodies will be reported.
Time frame: Up to 2 years 9 months
Part 1 and Part 2: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best response of complete response or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) maintained for at least 4 weeks.
Time frame: Up to 2 years 9 months
Part 1 and Part 2: Duration of Response (DOR)
DOR is defined as the duration from the date of initial documentation of a response to the date of first documented evidence of disease progression according to RECIST v. 1.1, or death due to any cause, whichever occurs first.
Time frame: Up to 2 years 9 months