A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: JNJ-78306358

• Registration Number: NCT04991740
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

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).

Detailed Description

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 Timeline

• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-05
• Study Start: 2021-10-24
• Primary Completion: 2023-02-09
• Study Completion: 2023-02-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

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Exclusion Criteria

• Active central nervous system involvement
• Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be Grade 2)
• Clinically significant pulmonary compromise
• Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug
• Solid organ or bone marrow transplantation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 2: Dose Expansion	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.
Part 1: Dose Escalation	JNJ-78306358	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Incidence of Adverse Events (AEs)	Up to 2 years and 4 months	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.
Number of Participants with AEs by Severity	Up to 2 years and 4 months	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.
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)	Up to 21 days	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.

Secondary Outcome Measures

Name	Time	Method
Area Under the Serum Concentration-time Curve From Time t1 to t2 (AUC[t1-t2]) of JNJ-78306358	Up to 2 years and 4 months	AUC(t1-t2) is defined as the area under the serum concentration-time curve from time t1 to t2.
Accumulation Ratio (RA) of JNJ-78306358	Up to 2 years and 4 months	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.
Number of Participants with Anti-JNJ-78306358 Antibodies	Up to 2 years and 4 months	Number of participants with anti-JNJ-78306358 antibodies will be reported.
Overall Response Rate (ORR)	Up to 2 years and 4 months	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).
Duration of Response (DOR)	Up to 2 years and 4 months	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.
Maximum Serum Concentration (Cmax) of JNJ-78306358	Up to 2 years and 4 months	Cmax is defined as maximum serum concentration of JNJ-78306358.
Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-78306358	Up to 2 years and 4 months	Tmax is defined as time to reach maximum observed serum concentration of JNJ-78306358.

Trial Locations

Locations (5)

Rambam Medical Center; 🇮🇱 Haifa, Israel

Hosp. Univ. Vall D Hebron; 🇪🇸 Barcelona, Spain

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Hosp. Univ. Fund. Jimenez Diaz; 🇪🇸 Madrid, Spain

Hosp. Univ. Hm Sanchinarro; 🇪🇸 Madrid, Spain