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| ID | Type | Description | Link |
|---|---|---|---|
| 87890387STM1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2023-505358-16-00 | Registry Identifier | EUCT number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-87890387 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-87890387 | Drug | JNJ-87890387 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 2 years 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and Part 2: Serum Concentration of JNJ-87890387 | Serum concentration of JNJ-87890387 will be reported. | Up to 2 years 9 months |
| Part 1 and Part 2: Maximum Observed Serum Concentration (Cmax) of JNJ-87890387 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years 9 months |
| Part 1 and Part 2: Cancer Antigen (CA) 125 Response Rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Start Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States | |
| Sarah Cannon Research Institute |
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.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Cmax is defined as maximum observed serum concentration of JNJ-87890387.
| Up to 2 years 9 months |
| 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. | 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 | AUC(t1-t2) is defined as area under the serum concentration versus time curve from time t1 to time t2 of JNJ-87890387. | 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 | AUC(0-tau) is defined as area under the serum concentration versus time curve from time 0 to time tau of JNJ-87890387. | Up to 2 years 9 months |
| 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. | Up to 2 years 9 months |
| 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. | Up to 2 years 9 months |
| 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. | Up to 2 years 9 months |
| 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. | Up to 2 years 9 months |
| 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. | 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. |
| Up to 2 years 9 months |
| Recruiting |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| Centre Leon Berard | Recruiting | Lyon | 69008 | France |
| Institut Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| Hosp Univ Vall D Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hosp. Univ. 12 de Octubre | Recruiting | Madrid | 28041 | Spain |