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JNJ-70218902 for Advanced Stage Cancer

Phase 1

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

Measurable or evaluable disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.5 years

Awards & highlights

Study Summary

This trial is testing a new drug to see what the best dose is and how well it works.

Who is the study for?

This trial is for adults with advanced solid tumors, specifically metastatic castration-resistant prostate cancer. Participants must have a good performance status (able to carry out daily activities), proper organ function, and if applicable, ongoing hormone therapy. They should have tried at least one prior cancer treatment but can't join if they still have significant side effects from past treatments or certain serious health conditions.Check my eligibility

What is being tested?

The study is testing JNJ-70218902 to find the safest and most effective dose for Phase 2 trials. Part 1 of the study will determine the maximum tolerated dose and Part 2 will assess safety at this recommended dose in participants with advanced stage solid tumors.See study design

What are the potential side effects?

While specific side effects of JNJ-70218902 are not listed here, common ones may include reactions at the injection site, fatigue, nausea, changes in blood counts affecting immunity or clotting risk, liver or kidney function changes. Allergic reactions could occur in those sensitive to the drug's components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer can be measured or seen on tests.

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I have previously received treatment targeting the androgen receptor or chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 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

Part 1 and Part 2: Number of Participants with AEs by Severity

Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

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

Secondary outcome measures

Accumulation Ratio (RA) of JNJ-70218902

Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-70218902

Area Under the Serum Concentration-time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-70218902

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose ExpansionExperimental Treatment1 Intervention

Participants with mCRPC will receive JNJ-70218902 at the RP2D determined in Part 1.

Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention

Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-70218902. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,226 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,823 Total Patients Enrolled

Media Library

JNJ-70218902 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04397276 — Phase 1

Tumors Research Study Groups: Part 2: Dose Expansion, Part 1: Dose Escalation

Tumors Clinical Trial 2023: JNJ-70218902 Highlights & Side Effects. Trial Name: NCT04397276 — Phase 1

JNJ-70218902 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04397276 — Phase 1

Frequently Asked Questions

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

Does JNJ-70218902 possess the necessary regulatory approval to be marketed?

"There is only limited information about JNJ-70218902's safety and efficacy, so its rating on the scale of 1 to 3 was a 1."

Answered by AI

Is there still capacity for individuals to join this research study?

"Indications from clinicaltrials.gov suggest that this particular study, which was posted on July 10th 2020 and last updated November 3rd 2022, is not currently in the process of sourcing participants. Despite this setback, there are still 2379 trials actively searching for enrollees at present."

Answered by AI

How many medical sites are offering this trial to participants?

"This clinical study is being conducted in the Memorial Sloan Kettering Cancer Center of New york City, Princess Margaret Hospital located in Toronto Canada and Massachusetts General based out of Boston USA alongside 6 other medical centres."

Answered by AI

What are the core goals of this clinical experiment?

"The primary outcome of this 2.5-year long study is the amount of participants that experience Dose-Limiting Toxicity (DLT). Secondary endpoints include Number of Participants With Anti-JNJ-70218902 Antibodies, Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) and Maximum Observed Serum Concentration (Cmax)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors

2020. "A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04397276.

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