Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 63709178AML1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2016-000208-27 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to characterize the safety and tolerability of JNJ-63709178 and identify the recommended Phase 2 dose(s) (RP2D) and schedule for JNJ-63709178 in Part 1 and to characterize the safety and tolerability of JNJ-63709178 at the RP2D(s) in Part 2.
This is first-in-human (FIH) Phase 1, open-label (identity of assigned study drug will be known), multicenter, dose escalation study with dose expansion to identify the RP2D and to evaluate the safety, tolerability, and preliminary antitumor activity of JNJ-63709178 in adult participants with relapsed or refractory acute myeloid leukemia (AML) who are ineligible for or have exhausted standard therapeutic options. The study will be conducted in 2 parts: dose escalation and dose expansion. The study is divided into 3 periods: a Screening Phase (within 28 days before the first dose of study drug), a Treatment Phase (first dose of study drug until the last dose of study drug) and a Post-treatment Follow-up Phase (up to the end of study participation or end of study). Participants' safety will be monitored throughout the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants will receive JNJ-63709178 in Part 1 (in different cohorts). Each subsequent cohort will receive JNJ-63709178 at an increased dose level. Ascending doses may be given initially to minimize or prevent cytokine release syndrome. Dose escalation will continue until the maximum tolerated dose is reached or all planned doses are administered. |
|
| Part 2: Dose Expansion | Experimental | Participants will receive JNJ-63709178 at the recommended Phase 2 dose(s) (RP2D) determined in dose expansion phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-63709178 | Drug | Participants will receive JNJ-63709178 in Part 1 and Part 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of participants with dose-limiting toxicity (DLT) | Up to Day 28 | |
| Part 1: Type of dose-limiting toxicity (DLT) | Up to Day 28 | |
| Part 2: Number of participants with adverse events and serious adverse events | Up to 1.5 years | |
| Part 2: Number of participants with adverse events by severity | Up to 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Serum concentration of JNJ-63709178 | Up to 1.5 years | |
| Part 2: JNJ-63709178 Receptor occupancy | Up to 1.5 years | |
| Part 2: Number of participants with depletion of CD123 expressing cells |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Detroit | Michigan | United States | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 1.5 years |
| Part 2: Systemic cytokine concentration | Up to 1.5 years |
| Part 2: Concentration of markers of T cell activation | Up to 1.5 years |
| Part 2: Anti- JNJ-63709178 antibodies concentration | Up to 1.5 years |
| Part 2: Overall response rate (ORR) | ORR rate is defined as the rate of complete response (CR) plus CR with incomplete recovery (CRi) plus CR with partial hematologic recovery (CRh). | Up to 1.5 years |
| Part 2: Event-free survival (EFS) | EFS is defined as time from start of treatment to the date of an event, that is, first documented treatment failure, relapse from CR, CRi, or CRh, or death due to any cause. | Up to 1.5 years |
| Part 2: Relapse-free survival (RFS) | RFS is defined as time from CR, CRi, or CRh confirmed objective response to relapse from CR, CRi, or CRh or death from any cause. | Up to 1.5 years |
| New York |
| New York |
| United States |
| Charlotte | North Carolina | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |
| Barcelona | Spain |
| Madrid | Spain |
| Seville | Spain |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided