What side effects are associated with this type of intervention?

Common treatments for tumors, including chemotherapy agents like oxaliplatin, fluorouracil, and capecitabine, often cause side effects such as neuropathy, hand-foot syndrome, diarrhea, nausea, vomiting, stomatitis, fatigue, and alopecia. Investigational therapies, similar to JNJ-70218902, may also present immune-related adverse events, fatigue, and organ-specific toxicities. These side effects are typical of both traditional chemotherapeutic agents and newer targeted treatments.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of advanced-stage solid tumors, often focusing on targeted therapies and immunotherapies. For instance, pembrolizumab and nivolumab are immune checkpoint inhibitors that have been approved for various cancers, including melanoma and non-small cell lung cancer. Additionally, drugs like cabozantinib, a tyrosine kinase inhibitor, have been approved for medullary thyroid cancer and renal cell carcinoma. These treatments, while having different mechanisms of action, share a common goal of targeting specific pathways or enhancing the immune response to combat tumor growth.

What other types of research exist?

Promising novel alternatives to JNJ-70218902 for tumor patients include: 1) OSU-03012, a PDK-1 inhibitor, which has shown significant growth inhibition in schwannoma models. 2) JTP-70902, a MEK1/2 inhibitor, effective in colorectal cancer models. 3) LY2835219, a CDK4/6 inhibitor, demonstrating cell-cycle arrest and tumor growth inhibition in melanoma models. 4) SR18662, a small molecule with potent antitumor activity in colorectal cancer models. These alternatives have shown efficacy in preclinical or clinical studies and represent potential options for tumor treatment.

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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

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

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently using any other cancer treatments or experimental drugs.

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I have cancer that has spread to my brain.

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Side effects from my previous cancer treatments have mostly gone, except for hair loss or skin color changes.

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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

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

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 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 / 7Eligibility criteria met

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.