Health TrialsbyHealthPanel

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

ConditionNeoplasms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohnson & Johnson Enterprise Innovation Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • JNJ-87704916

    Drug

    JNJ-87704916 will be administered as an intratumoral injection.

  • Cetrelimab

    Drug

    Cetrelimab will be administered.

  • Standard of Care PD(L)-1

    Drug

    Frontline anti-PD(L)-1 antibody therapy will be administered as standard of care treatment.

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Part 1: Dose EscalationExperimental treatment 2 interventions
Group B: Part 2: Dose ExpansionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)

The DLTs are specific adverse events with defined non-hematological toxicities or hematologic toxicities as per the study protocol.

Time frame
Up to 5 years
2

Number of Participants with Adverse Events (AEs) by Severity

An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.

Time frame
From first dose up to 100 days after last dose of study treatment (up to 5 years)

Secondary outcomes

1

Parts 1 and 2: Percentage of Participants With Objective Response (OR)

OR is defined as the percentage of participants who have best response of Complete Response (CR) or Partial Response (PR) according to response evaluation criteria in solid tumors (RECIST) v1.1.

Time frame
Up to 5 years
2

Parts 1 and 2: Percentage of Participants With Disease Control (DC)

DC is defined as the percentage of participants who have achieved complete response, partial response, and stable disease for at least 2 consecutive assessments according to RECIST v1.1.

Time frame
Up to 5 years
3

Parts 1 and 2: Duration of Response (DOR)

DOR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of relapse according to RECIST v1.1, or death due to any cause, whichever occurs first.

Time frame
Up to 5 years
4

Part 2: Progression Free Survival (PFS)

PFS is defined as the time from treatment initiation until disease progression or worsening or death due to any cause.

Time frame
From treatment initiation until disease progression or worsening or death due to any cause (up to 5 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johnson & Johnson Enterprise Innovation Inc.

Lead sponsor

Source ClinicalTrials.gov
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