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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-10

Study Completion Date

2025-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) and maximum tolerated dose (MTD) of JNJ-70218902 in Part 1, and to determine the safety of JNJ-70218902 RP2D(s) in Part 2.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors

NCT03926013

Neoplasms

COMPLETED PHASE1

A Study of JNJ-79032421 Targeting Mesothelin for Advanced Stage Solid Tumors

NCT06255665

Advanced Stage Solid Tumors

COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 in Participants With Selected Advanced Solid Tumors

NCT04972981

Advanced Solid Tumors

COMPLETED PHASE1

Study of RP2 Monotherapy and RP2 in Combination With Nivolumab in Patients With Solid Tumors

NCT04336241

Cancer

RECRUITING PHASE1

An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors

NCT00280397

Cancer: Solid Tumors

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

JNJ-70218902, the investigational drug, has been shown in pre-clinical studies to work by attaching to cancer cells and activating immune cells to kill these cancer cells. This study will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2) and will enroll adult men with Metastatic Castration-Resistant Prostate Cancer (MCRPC). Study evaluations will include preliminary clinical efficacy, safety, pharmacokinetics, biomarkers and immunogenicity evaluations. This study is divided into 3 periods: screening, treatment and post-treatment. The total duration of the study will be 2.5 years approximately.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part 1: Dose Escalation

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.

Group Type EXPERIMENTAL

JNJ-70218902

Intervention Type DRUG

JNJ-70218902 will be administered.

Part 2: Dose Expansion

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

Group Type EXPERIMENTAL

JNJ-70218902

Intervention Type DRUG

JNJ-70218902 will be administered.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

JNJ-70218902

JNJ-70218902 will be administered.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histology: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed
* Measurable or evaluable disease
* Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy
* If the participant is receiving treatment with gonadotropin-releasing hormone agonists or antagonist analogs (GnRH), this therapy must have been initiated prior to first dose of study drug and must be continued throughout the study
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
* Adequate organs functions

Exclusion Criteria

* Known brain metastases
* Concurrent use of any other anticancer treatment or investigational agent for the treatment of advanced disease
* Toxicities related to prior anticancer treatments have not returned to Grade less than or equal to (\<=) 1 or baseline, except for alopecia and vitiligo
* Solid organ or bone marrow transplantation
* Known allergies, hypersensitivity, or intolerance to JNJ-70218902 or its excipients
* Certain comorbidities

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No