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JNJ-87704916

Phase 1

Neoplasms | Small molecule | Oncology |Johnson & Johnson|Last Updated: Aug 28, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment126

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-87704916 · 1 trial · 1 indication

Phase 1 1
NCT06311578A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid TumorsNeoplasms
RECRUITING126 Analytics
PHASE1RECRUITING
A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
Up to 5 years

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

Number of Participants with Adverse Events (AEs) by Severity
From first dose up to 100 days after last dose of study treatment (up to 5 years)

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.

Secondary Endpoints

Parts 1 and 2: Percentage of Participants With Objective Response (OR)
Up to 5 years
Parts 1 and 2: Percentage of Participants With Disease Control (DC)
Up to 5 years
Parts 1 and 2: Duration of Response (DOR)
Up to 5 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Dose EscalationEXPERIMENTALParticipants with advanced solid tumors will receive JNJ-87704916 alone and in combination with cetrelimab. Ascending dose levels will be sequentially tested.
Part 2: Dose ExpansionEXPERIMENTALPart 2 will consist of three cohorts: Cohort A, B and C. Participants in cohort A\&B with metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1. Cohort C will evaluate JNJ-87704916 treatment in combination with ongoing Standard of care (SoC) PD(L)-1 antibody therapy in frontline treatment of NSCLC.

Interventions

NameTypeDescription
JNJ-87704916DRUGJNJ-87704916 will be administered as an intratumoral injection.
CetrelimabDRUGCetrelimab will be administered.
Standard of Care PD(L)-1DRUGFrontline anti-PD(L)-1 antibody therapy will be administered as standard of care treatment.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

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 * Easter...

Countries:United StatesCanadaFranceSpain
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Recent Changes (Last 90 Days)

LOWAug 28, 2026NCT06311578lastUpdatePostDate: changed
LOWAug 28, 2026NCT06311578lastUpdatePostDate: changed
MEDIUMJul 6, 2026NCT06311578Completion: 2032-08-26 → 2033-02-14
MEDIUMJul 6, 2026NCT06311578Completion: 2032-08-26 → 2033-02-14

Frequently asked questions about JNJ-87704916

What is JNJ-87704916 used for?

JNJ-87704916 is an investigational small molecule being developed for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is currently being studied in patients with advanced solid tumors as a potential oncology therapy.

Who makes JNJ-87704916?

JNJ-87704916 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating advanced solid tumors.

What phase is JNJ-87704916 in?

JNJ-87704916 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to assess its safety, tolerability, and potential efficacy in patients with advanced solid tumors.

What clinical trials is JNJ-87704916 in?

JNJ-87704916 is being evaluated in a Phase 1 clinical trial with the identifier NCT06311578. This study is investigating the drug as a monotherapy and in combination for the treatment of advanced solid tumors. The trial is currently recruiting participants and is being conducted in the United States, Canada, France, and Spain.

How does JNJ-87704916 work?

JNJ-87704916 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied for its potential to treat advanced solid tumors, and its mechanism of action is under investigation in clinical trials.