The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-79032421 and to determine the safety and tolerability of JNJ-79032421 at the RP2D(s).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
JNJ-79032421 will be administered.
JNJ-79032421 will be administered at RP2D regimen.
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp Univ Fund Jimenez Diaz
Madrid, Spain
Hosp Univ Hm Sanchinarro
Madrid, Spain
Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
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 first 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 3 years
Part 1 and Part 2: Serum Concentration of JNJ-79032421
Serum concentration of JNJ-79032421 will be reported.
Time frame: Up to 3 years
Part 1 and Part 2: Maximum Observed Analyte Concentration (Cmax) of JNJ-79032421
Cmax is defined as maximum observed analyte concentration of JNJ-79032421.
Time frame: Up to 3 years
Part 1 and Part 2: Time to Reach Maximum Observed Analyte Concentration (Tmax) of JNJ-79032421
Tmax is defined as the time to reach maximum observed analyte concentration of JNJ-79032421.
Time frame: Up to 3 years
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Part 1 and Part 2: Area Under the Curve from Time t1 to Time t2 (AUC[t1-t2]) of JNJ-79032421
AUC(t1-t2) is defined as area under the analyte concentration for a specific time interval defined by t1 and t2 (AUC\[t1-t2\]) of JNJ-79032421.
Time frame: Up to 3 years
Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-79032421 Antibodies
The maximum titers of antibodies to JNJ-79032421 will be summarized for participants positive with antibodies to JNJ-79032421.
Time frame: Up to 3 years
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 v1.1), and revised mRECIST for assessment of malignant pleural mesothelioma.
Time frame: Up to 3 years
Part 1 and Part 2: Duration of Response (DOR)
DOR is defined as the duration from the date of initial documentation of a response (PR or CR) to the date of first documented evidence of relapse or death according to RECIST v. 1.1, and revised mRECIST for malignant pleural mesothelioma.
Time frame: Up to 3 years
Part 1 and Part 2: Cancer Antigen (CA) 125 Response Rate for Ovarian Cancer Only
CA 125 response rate is defined as the proportion of participants with ovarian cancer who achieved a partial response or complete response according to the Gynecologic Cancer Intergroup (GCIG) response criteria for CA 125. A CA 125 response is defined as at least 50 percentage (%) reduction in CA 125 levels from a pretreatment sample which must be confirmed and maintained for at least 28 days.
Time frame: Up to 3 years