ClinicalTrials.gg
RecruitingNCT06178614Updated Nov 4, 2026

A Study of JNJ-87890387 for Advanced Solid Tumors

A Phase 1 interventional study of JNJ-87890387 in Neoplasms and Advanced Solid Tumors, sponsored by Janssen Research & Development, LLC. Recruiting at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 10 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Neoplasms
  • Advanced Solid Tumors

Browse trials for

03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 200 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.

Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have or cytologically confirmed, , 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 per 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* (ULN) during screening
  • All participants in Part 1 and Part 2 must consent to provide an archived tumor tissue sample at screening
  • Have an (ECOG) performance status of 0 to 1 at screening
  • Be willing and able to adhere to the lifestyle restrictions specified in this protocol.

Exclusion criteria

Exclusion Criteria:

  • Active Central Nervous System (CNS) involvement with the exception of locally treated that are clinically stable and asymptomatic for > 2 weeks and who are off or receiving low-dose 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
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    JNJ-87890387

    In 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.

    Drug: JNJ-87890387

Interventions

  • DrugJNJ-87890387

    JNJ-87890387 will be administered.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: Up to 2 years 9 months

Secondary outcomes

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

    Serum concentration of JNJ-87890387 will be reported.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to 2 years 9 months

Other outcomes

  1. Part 1 and Part 2: Time to Response (TTR)

    TTR is defined for the responders as the time from the date of the first dose of JNJ-87890387 to the date of the first documented response.

    Time frame: Up to 2 years 9 months

  2. Part 1 and Part 2: Cancer Antigen (CA) 125 Response Rate

    CA 125 response rate is defined as the proportion of participants with ovarian cancer who achieved a partial response or complete response according to the Gynecologic Cancer Intergroup (GCIG) response criteria for CA 125, maintained for at least 4 weeks. A CA 125 response is defined as at least 50 percentage (%) reduction in CA 125 levels from a pretreatment sample which must be confirmed and maintained for at least 28 days.

    Time frame: Up to 2 years 9 months

07

Study locations

6 of 6 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Data sharing details ↗ · innovativemedicine.jnj.com

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
2 updates, last Nov 4, 2026
Show all 2 updates
  1. Nov 4, 2026
    Minor edits only
    + 1 other change: verification date
  2. Sep 25, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06178614
Responsible party
Sponsor
First posted
Dec 21, 2023
Start date
Dec 14, 2023
Primary completion
Mar 16, 2027 (estimated)
Completion
Feb 7, 2029 (estimated)
Last update
Nov 4, 2026

Study contacts

Study Contact
Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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