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NeoplasmsPhase 1NCT04397276

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

A Phase 1 study testing JNJ-70218902 in people with Neoplasms, run by Janssen Research & Development, LLC at 7 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Neoplasms
What is being tested?
JNJ-70218902
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
7 sitesin 3 countries
Study dates
10 Jul 2020to 16 Sep 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 3 countries.

7 sites in 3 countries

Spain3 sites

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050

Other trials in Spain

Canada2 sites

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BC Cancer Agency - Vancouver BC

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Israel2 sites

  • Rambam Medical Center

    Haifa, 31096

  • Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

About this study

Official title: A Phase 1 Study of JNJ-70218902, a T Cell Redirecting Agent, in Advanced Stage Solid Tumors

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.

Read the detailed description

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
Neoplasms
Being tested
JNJ-70218902
Keywords
metastatic Castration-Resistant Prostate Cancer (mCRPC), Prostate Cancer
Medical subject headings
Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-70218902Drug

    JNJ-70218902 will be administered.

Study groups in NCT04397276
Study groupRoleWhat they receive
Part 1: Dose EscalationExperimentalParticipants 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.
Receives: Drug: JNJ-70218902
Part 2: Dose ExpansionExperimentalParticipants with mCRPC will receive JNJ-70218902 at the RP2D determined in Part 1.
Receives: Drug: JNJ-70218902

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

    Measured: Up to 2.5 years

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

    Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

    Measured: Up to 21 days

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

    Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS), which will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

    Measured: Up to 2.5 years

Secondary outcomes (11)

  1. Maximum Observed Serum Concentration (Cmax) of JNJ-70218902

    Cmax is the maximum observed serum concentration of JNJ-70218902.

    Measured: Up to 2.5 years

  2. Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-70218902

    Tmax is defined as time to reach maximum observed serum concentration.

    Measured: Up to 2.5 years

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

    AUC(t1-t2) is defined as the area under the serum concentration-time curve from time t1 to t2.

    Measured: Up to 2.5 years

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

    AUCtau is the measure of the serum drug concentration from time zero to end of dosing interval.

    Measured: Up to 2.5 years

  5. Minimum Observed Serum Concentration (Cmin) of JNJ-70218902

    Cmin is the minimum observed serum concentration of JNJ-70218902.

    Measured: Up to 2.5 years

  6. Accumulation Ratio (RA) of JNJ-70218902

    Accumulation Ratio (RA) is calculated as area under the plasma concentration-time curve from time zero to 24 hours (AUC [0-24]) value at steady state divided by AUC (0-24) value after first dose.

    Measured: Up to 2.5 years

  7. Systemic Cytokine Concentrations

    Cytokines concentration will be measured for biomarker assessment.

    Measured: Up to 2.5 years

  8. Serum Prostate Specific Antigen (PSA) Concentration

    Serum prostate specific antigen (PSA) concentration will be measured.

    Measured: Up to 2.5 years

  9. Number of Participants With Anti-JNJ-70218902 Antibodies

    Number of participants with anti-JNJ-70218902 antibodies will be assessed.

    Measured: Up to 2.5 years

  10. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants who have a Partial Response (PR) or better according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3).

    Measured: Up to 2.5 years

  11. Duration of Response (DOR)

    Duration of response (DOR) will be calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3 or RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first.

    Measured: Up to 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2020
  2. Study start10 Jul 2020
  3. Primary completion16 Sep 2025
  4. Study completion16 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04397276
Sponsor's protocol ID
CR108765
Other IDs
70218902EDI1001, 2019-004885-16, 2024-516351-40-00, 2019
Status last verified
Feb 2026
First submitted
18 May 2020
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-70218902 in people with Neoplasms, run by Janssen Research & Development, LLC at 7 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Spain, Canada, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (time frame: Up to 2.5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04397276.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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