NCT04991740

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

A Phase 1 Study of JNJ-78306358, a T Cell Redirecting Bispecific Antibody Targeting HLA-G for Advanced Stage Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	JNJ-78306358	JNJ-78306358 will be administered.

Timeline

• Start date: 2021-10-24
• Primary completion: 2023-02-09
• Completion: 2023-02-09
• First posted: 2021-08-05
• Last updated: 2023-03-24

Locations

5 sites across 2 countries: Israel, Spain

Regulatory

• FDA-regulated drug study