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NCT Number: NCT06178614

A Study of JNJ-87890387 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).

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Key information

Conditions

Neoplasms Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre Leon Berard, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

JNJ-87890387

Drug

JNJ-87890387 will be administered.

Primary outcomes

  1. 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

    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.

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

    Time frame: Up to 2 years 9 months

    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.

Secondary outcomes

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

    Time frame: Up to 2 years 9 months

    Serum concentration of JNJ-87890387 will be reported.

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

    Time frame: Up to 2 years 9 months

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

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

    Time frame: Up to 2 years 9 months

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

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

    Time frame: Up to 2 years 9 months

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

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

    Time frame: Up to 2 years 9 months

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

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

    Time frame: Up to 2 years 9 months

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

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

    Time frame: Up to 2 years 9 months

    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.

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

    Time frame: Up to 2 years 9 months

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

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

    Time frame: Up to 2 years 9 months

    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.

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

    Time frame: Up to 2 years 9 months

    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.

Other outcomes

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

    Time frame: Up to 2 years 9 months

    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.

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

    Time frame: Up to 2 years 9 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Dec 21, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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