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NeoplasmsPhase 1NCT06178614

A Study of JNJ-87890387 for Advanced Solid Tumors

A Phase 1 study testing JNJ-87890387 in people with Neoplasms and Advanced Solid Tumors, run by Janssen Research & Development, LLC at 6 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to determine safety and recommended phase 2 dose(s) (RP2Ds) of JNJ-87890387 and to determine the safety of JNJ-87890387 at the RP2D(s). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Advanced Solid Tumors
What is being tested?
JNJ-87890387
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
6 sitesin 3 countries
Study dates
14 Dec 2023to 7 Feb 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have histologically or cytologically confirmed, metastatic, or unresectable solid tumor of one of the following types: a) Renal cell cancer (RCC)-clear cell or papillary carcinoma; b) Endometrioid ovarian cancer c) Endometrioid uterine carcinoma; d) Colorectal adenocarcinoma (CRC); e) Lung adenocarcinoma
  • Have measurable or evaluable disease: Part 1- Either measurable or evaluable disease; Part 2- At least 1 measurable lesion per RECIST v1.1. Participants with ovarian cancer without a measurable lesion must have disease evaluable per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or have cancer antigen (CA) 125 greater than (>) 2*upper limit of normal (ULN) during screening
  • All participants in Part 1 and Part 2 must consent to provide an archived tumor tissue sample at screening
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening
  • Be willing and able to adhere to the lifestyle restrictions specified in this protocol.

Who cannot join

  • Active Central Nervous System (CNS) involvement with the exception of locally treated brain metastases that are clinically stable and asymptomatic for > 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to [<=]10 milligrams [mg] prednisone or equivalent) for at least 2 weeks prior to start of study treatment
  • Toxicity from prior anticancer therapy that has not resolved to Grade <=1 (except alopecia, vitiligo, Grade <=2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement)
  • History of Grade greater than or equal to (>=) 2 immune-related AE(s) with prior immunotherapy that led to discontinuation of previous immunotherapy with the exception of Grade 2 and Grade 3 immune-related AEs that responded to treatment and that did not recur following rechallenge. Endocrinopathies that are stable on hormone replacement therapy or that have resolved are allowed.
  • History of solid organ or hematologic stem cell transplantation
  • Any episode of partial or complete bowel obstruction requiring hospitalization within 30 days prior to first dose of study treatment

Trial locations and contacts

6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

6 sites in 3 countries

United States2 sites, 2 recruiting

  • Start Midwest

    Grand Rapids, Michigan, 49546

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

    Recruiting

Other trials in United States

France2 sites, 2 recruiting

  • Centre Leon Berard

    Lyon, 69008

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Recruiting

Other trials in France

Spain2 sites, 2 recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

Other trials in Spain

About this study

Official title: A Phase 1 Study of JNJ-87890387, an Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3 (ENPP3) x CD3 Bispecific Antibody, for Advanced Solid Tumors

The purpose of this study is to determine safety and recommended phase 2 dose(s) (RP2Ds) of JNJ-87890387 and to determine the safety of JNJ-87890387 at the RP2D(s).

Being tested
JNJ-87890387
Medical subject headings
Neoplasms

What participants receive

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

  • JNJ-87890387Drug

    JNJ-87890387 will be administered.

Study groups in NCT06178614
Study groupRoleWhat they receive
JNJ-87890387ExperimentalIn Part 1 (Dose escalation) participants will receive JNJ-87890387. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified. In Part 2 (Dose expansion), participants will receive JNJ-87890387 at the RP2D regimen(s) determined in Part 1.
Receives: Drug: JNJ-87890387

What is being measured

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

  1. Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)

    Number of participants with DLTs will be reported. The DLTs are adverse events including certain high grade non-hematologic or hematologic toxicities, or toxicities meeting other specific criteria.

    Measured: Up to first 21 days after administration of the first full treatment dose

  2. Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity

    An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. 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) and immune effector cell-associated neurotoxicity syndrome events (ICANS), which will be graded by 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 years 9 months

Secondary outcomes (10)

  1. Part 1 and Part 2: Serum Concentration of JNJ-87890387

    Serum concentration of JNJ-87890387 will be reported.

    Measured: Up to 2 years 9 months

  2. Part 1 and Part 2: Maximum Observed Serum Concentration (Cmax) of JNJ-87890387

    Cmax is defined as maximum observed serum concentration of JNJ-87890387.

    Measured: Up to 2 years 9 months

  3. Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-87890387

    Tmax is defined as the time to reach maximum observed serum concentration of JNJ-87890387.

    Measured: Up to 2 years 9 months

  4. Part 1 and Part 2: Area Under the Curve from Time t1 to Time t2 (AUC[t1-t2]) of JNJ-87890387

    AUC(t1-t2) is defined as area under the serum concentration versus time curve from time t1 to time t2 of JNJ-87890387.

    Measured: Up to 2 years 9 months

  5. Part 1 and Part 2: Area Under the Curve from Time Zero to Time tau (AUC[0-tau]) of JNJ-87890387

    AUC(0-tau) is defined as area under the serum concentration versus time curve from time 0 to time tau of JNJ-87890387.

    Measured: Up to 2 years 9 months

  6. Part 1 and Part 2: Minimum Observed Serum Concentration (Cmin) of JNJ-87890387

    Cmin is defined as the minimum observed serum concentration of JNJ-87890387.

    Measured: Up to 2 years 9 months

  7. Part 1 and Part 2: Accumulation Ratio of JNJ-87890387

    Accumulation ratio of JNJ-87890387 will be reported. The AR is the accumulation ratio calculated as Cmax or AUC after multiple doses divided by Cmax or AUC after the first dose, respectively.

    Measured: Up to 2 years 9 months

  8. Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-87890387 Antibodies

    Number of participants with presence of anti-JNJ-87890387 antibodies will be reported.

    Measured: Up to 2 years 9 months

  9. Part 1 and Part 2: Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with a best response of complete response or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) maintained for at least 4 weeks.

    Measured: Up to 2 years 9 months

  10. Part 1 and Part 2: Duration of Response (DOR)

    DOR is defined as the duration from the date of initial documentation of a response to the date of first documented evidence of disease progression according to RECIST v. 1.1, or death due to any cause, whichever occurs first.

    Measured: Up to 2 years 9 months

Timeline

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

  1. First posted21 Dec 2023
  2. Study start14 Dec 2023
  3. Primary completion16 Mar 2027 (estimated)
  4. Study completion7 Feb 2029 (estimated)

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
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06178614
Sponsor's protocol ID
CR109339
Other IDs
87890387STM1001, 2023-505358-16-00, 2023
Status last verified
Nov 2026
First submitted
12 Dec 2023
Last updated
4 Nov 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 Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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-87890387 in people with Neoplasms and Advanced Solid Tumors, run by Janssen Research & Development, LLC at 6 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, France, Spain. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) (time frame: Up to first 21 days after administration of the first full treatment dose). The study lists 2 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 NCT06178614.

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 4 Nov 2026.

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