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Monoclonal Antibodies

Part 1: Dose Escalation for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Johnson & Johnson Enterprise Innovation Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial aims to find out if JNJ-87704916 is safe and effective when used alone or with cetrelimab.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors who have tried all standard treatments without success. They should be relatively active and well (ECOG grade 0 or 1) and not expecting a child, with measures taken to prevent pregnancy during the study.Check my eligibility

What is being tested?

The study is testing JNJ-87704916 both alone and combined with another drug called cetrelimab. It aims to find safe dosages and treatment schedules for patients with tough-to-treat solid tumors.See study design

What are the potential side effects?

Possible side effects of JNJ-87704916 and cetrelimab may include typical reactions like fatigue, nausea, skin issues, immune-related conditions, as well as potential injection site reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Adverse Events (AEs) by Severity

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

Secondary outcome measures

Part 2: Overall Survival (OS)

Part 2: Progression Free Survival (PFS)

Parts 1 and 2: Duration of Response (DOR)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 Cohort A: Dose ExpansionExperimental Treatment2 Interventions

Participants with relapsed/refractory metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1. Additional cohorts may be added to evaluate additional disease indications, or treatment regimens.

Group II: Part 1: Dose EscalationExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetrelimab

2022

Completed Phase 1

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Johnson & Johnson Enterprise Innovation Inc.Lead Sponsor

2 Previous Clinical Trials

151 Total Patients Enrolled

Johnson & Johnson Enterprise Innovation Inc Clinical TrialStudy DirectorJohnson & Johnson Enterprise Innovation Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the safety profile of Part 1: Dose Escalation in individuals undergoing treatment?

"Part 1: Dose Escalation is rated as a 1 on the safety scale by our team at Power. This designation reflects the early Phase 1 nature of the trial, where data supporting both safety and efficacy are still limited."

Answered by AI

Is this clinical trial currently accepting new participants?

"As per the details on clinicaltrials.gov, this medical investigation is currently seeking suitable participants. The trial was initially listed on 3/25/2024 and had its most recent update on 3/26/2024."

Answered by AI

What is the total number of participants being recruited for this research study?

"Affirmative. Information available on clinicaltrials.gov indicates that this trial is actively seeking participants. Initially posted on March 25, 2024, and last revised on March 26, 2024, the study aims to enroll a total of 66 patients from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06311578.

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