The purpose of this study is to determine the recommended phase 2 dose (RP2D) regimen(s) of JNJ-78306358 in Part 1 (Dose Escalation) and to determine the safety of JNJ-78306358 at the RP2D regimen(s) in Part 2 (Dose Expansion).
JNJ-78306358 is a bispecific antibody binding to CD3 on T cells and human leukocyte antigen G (HLA-G) on cancer cells. The study consists of a screening phase, a treatment phase, and a post-treatment follow-up phase. Study evaluations include safety, pharmacokinetics, biomarkers, immunogenicity, and efficacy (disease evaluations). The total study duration will be up to 2 years 4 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
JNJ-78306358 will be administered.
Rambam Medical Center
Haifa, Israel
Sourasky Medical Center
Tel Aviv, Israel
Hosp. Univ. Vall D Hebron
Barcelona, Spain
Hosp. Univ. Fund. Jimenez Diaz
Madrid, Spain
Hosp. Univ. Hm Sanchinarro
Number of Participants with Incidence of Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: Up to 2 years and 4 months
Number of Participants with AEs by Severity
Number of participants with AEs by severity will be reported. 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 (ICANS) events, which will be graded according to the 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 and 4 months
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Time frame: Up to 21 days
Maximum Serum Concentration (Cmax) of JNJ-78306358
Cmax is defined as maximum serum concentration of JNJ-78306358.
Time frame: Up to 2 years and 4 months
Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-78306358
Tmax is defined as time to reach maximum observed serum concentration of JNJ-78306358.
Time frame: Up to 2 years and 4 months
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Madrid, Spain
Area Under the Serum Concentration-time Curve From Time t1 to t2 (AUC[t1-t2]) of JNJ-78306358
AUC(t1-t2) is defined as the area under the serum concentration-time curve from time t1 to t2.
Time frame: Up to 2 years and 4 months
Accumulation Ratio (RA) of JNJ-78306358
RA is calculated as area under the plasma concentration-time curve from time zero to 24 hours (AUC \[0-24\]) value at steady state divided by AUC (0-24) value after first dose.
Time frame: Up to 2 years and 4 months
Number of Participants with Anti-JNJ-78306358 Antibodies
Number of participants with anti-JNJ-78306358 antibodies will be reported.
Time frame: Up to 2 years and 4 months
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR), according to response evaluation criteria in solid tumors (RECIST) version 1.1 and gynecological cancer inter group (GCIG) Cancer antigen 125 (CA 125) response criteria (for ovarian cancer participants only).
Time frame: Up to 2 years and 4 months
Duration of Response (DOR)
Duration of response (DOR) will be calculated among responders (PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the RECIST version 1.1 response criteria and GCIG CA 125 response criteria (for ovarian cancer participants only) or death due to any cause, whichever occurs first.
Time frame: Up to 2 years and 4 months