A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors

Johnson & Johnson (J&J)

Status and phase: Enrolling; Phase 1

Conditions: Neoplasms

Treatments: Drug: JNJ-87704916; Drug: Cetrelimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06311578

2023-506495-27-00 (Registry Identifier)

87704916LUC1001

Details and patient eligibility

About

The purpose of this study is to determine the safety, feasibility, recommended dose(s) and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• For Part 1: Individuals with a diagnosis of advanced or metastatic solid tumor exhausting all available standard of care therapy; Part 2: Individuals with histologically or cytologically confirmed metastatic or locally advanced NSCLC
• Have at least 1 injectable tumor
• Eastern cooperative oncology group (ECOG) performance status of grade 0 or 1
• A participant who can have children must have a negative pregnancy test before the first dose of study treatment and during the study
• Thyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy

Exclusion criteria

• Active disease involvement of the CNS (example, primary central nervous system tumors, metastases, leptomeningeal disease). Some exceptions are allowed
• Prior history of, or active, significant herpetic infections (example, herpetic keratitis or encephalitis) or active herpetic infections that require ongoing systemic anti-viral therapy
• Active infection or condition that requires treatment with systemic anti-infective agents (example, antibiotics, antifungals, or antivirals) within 7 days prior to the first dose of study treatment or chronic use of anti-infective agents
• History of solid organ or hematologic stem cell transplantation
• Known positive test result for human immunodeficiency virus (HIV) or other immunodeficiency syndrome
• History of allergy to protein-based therapies or history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Part 1: Dose Escalation

Experimental group

Description:

Participants with advanced solid tumors will receive JNJ-87704916 alone and in combination with cetrelimab. Ascending dose levels will be sequentially tested.

Treatment:

Drug: Cetrelimab

Drug: JNJ-87704916

Part 2: Dose Expansion

Experimental group

Description:

Part 2 will consist of two cohorts: Cohort A and Cohort B. Participants in both Cohorts with metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1.

Treatment:

Drug: Cetrelimab

Drug: JNJ-87704916