Your session is about to expire
← Back to Search
Other
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
Must not have
Concurrent use of any other anticancer treatment or investigational agent for the treatment of advanced disease
Known brain metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing JNJ-70218902, a drug that helps the immune system target and destroy cancer cells, in adult men with advanced prostate cancer that doesn't respond to usual treatments.
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.
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.
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 belowSelect...
I am fully active or can carry out light work.
Select...
My cancer can be measured or seen on tests.
Select...
I have previously received treatment targeting the androgen receptor or chemotherapy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not currently using any other cancer treatments or experimental drugs.
Select...
I have cancer that has spread to my brain.
Select...
Side effects from my previous cancer treatments have mostly gone, except for hair loss or skin color changes.
Select...
I have had a solid organ or bone marrow transplant.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for tumors include chemotherapy, immunotherapy, and targeted therapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect healthy cells, leading to side effects.
Immunotherapy, such as anti-PD-1 or anti-PD-L1 therapies, boosts the body's immune system to recognize and destroy cancer cells. Targeted therapies, like tyrosine kinase inhibitors, specifically target molecular abnormalities in cancer cells, minimizing damage to normal cells.
Understanding these mechanisms is crucial for tumor patients as it helps in selecting the most appropriate treatment based on the tumor's characteristics and the patient's overall health, potentially improving outcomes and reducing side effects.
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
1,008 Previous Clinical Trials
6,402,821 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
773 Previous Clinical Trials
3,980,848 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on GnRH therapy and started it before the study drug.I am fully active or can carry out light work.I am not currently using any other cancer treatments or experimental drugs.I have cancer that has spread to my brain.My cancer can be measured or seen on tests.Side effects from my previous cancer treatments have mostly gone, except for hair loss or skin color changes.My organs are functioning well.I have had a solid organ or bone marrow transplant.My prostate cancer has spread and is resistant to hormonal therapy.I have previously received treatment targeting the androgen receptor or chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: Dose Expansion
- Group 2: Part 1: Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.