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RecruitingInterventionalPhase 1

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

NCT ID: NCT06178614Sponsor: Janssen Research & Development, LLCLast updated: 2026-06-05

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).

Arms & interventions

  • DrugJNJ-87890387

    JNJ-87890387 will be administered.

Outcome measures

Primary

  • 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

  • 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

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

    Time frame: Up to 2 years 9 months

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

    Time frame: Up to 2 years 9 months

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

    Time frame: Up to 2 years 9 months

  • 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

  • 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

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

    Time frame: Up to 2 years 9 months

  • Part 1 and Part 2: Accumulation Ratio of JNJ-87890387

    Time frame: Up to 2 years 9 months

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

    Time frame: Up to 2 years 9 months

  • Part 1 and Part 2: Objective Response Rate (ORR)

    Time frame: Up to 2 years 9 months

  • Part 1 and Part 2: Duration of Response (DOR)

    Time frame: Up to 2 years 9 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (2)

Start Midwest

Grand Rapids, Michigan, 49546

Recruiting

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Recruiting