A Phase 1 interventional study of JNJ-78306358 in Neoplasms, sponsored by Janssen Research & Development, LLC. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-24.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
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.
Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
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Histologically or cytologically confirmed, metastatic or unresectable solid tumor of one of the following types:
a. Renal Cell Carcinoma (RCC): clear cell or papillary carcinoma, b. ovarian cancer: high grade serous epithelial ovarian; primary peritoneal or fallopian tube cancer; 1. low grade or non-serous histologies are not allowed; c. colorectal cancer (CRC); d. other tumor types (including lung adenocarcinoma, endometrial cancer, and pancreas cancer) may be enrolled with sponsor approval
Exclusion Criteria:
Participants with renal cell carcinoma (RCC), ovarian cancer, colorectal cancer (CRC), and other tumor types with sponsor approval will receive JNJ-78306358. The dose will be escalated sequentially based on the decisions of the study evaluation team until the recommended phase 2 dose (RP2D) regimen(s) have been identified.
Drug: JNJ-78306358
Participants with RCC, ovarian cancer, CRC and other types of tumors will receive JNJ-78306358 at the RP2D regimen(s) determined in Part 1.
Drug: JNJ-78306358
JNJ-78306358 will be administered.
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
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
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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