NCT02715011

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2016

Longer than P75 for phase_1

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

4.8 years

First QC Date

March 16, 2016

Last Update Submit

August 30, 2021

Conditions

Leukemia, Myeloid, Acute

Keywords

Leukemia, Myeloid, AcuteJNJ-63709178

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (9)

  • 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

    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

  • +4 more secondary outcomes

Study Arms (2)

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.

Drug: JNJ-63709178

Part 2: Dose Expansion

EXPERIMENTAL

Participants will receive JNJ-63709178 at the recommended Phase 2 dose(s) (RP2D) determined in dose expansion phase.

Drug: JNJ-63709178

Interventions

JNJ-63709178DRUG

Participants will receive JNJ-63709178 in Part 1 and Part 2.

Part 1: Dose EscalationPart 2: Dose Expansion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of acute myeloid leukemia (AML) according to the World Health Organization 2008 criteria with relapsed or refractory disease and ineligible for or have exhausted standard therapeutic options
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Hematology laboratory parameters within the Protocol specified range
  • Chemistry laboratory parameters within the Protocol specified range
  • A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin \[b-hCG\]) or urine test prior to the first dose of study drug

You may not qualify if:

  • Acute promyelocytic leukemia
  • Active central nervous system involvement
  • Prior solid organ transplantation
  • Prior hematopoietic stem cell transplant within 6 months of enrollment. If the participant had an allogenic transplant there must be no apparent signs of graft versus host disease and participants must have discontinued all immunosuppressive therapies for at least 4 weeks
  • Prior treatment with a CD123xCD3 bispecific agent, T cells expressing CD123 specific chimeric antigen receptor, or toxin-conjugated to CD123 antibodies; prior treatment with naked anti-CD123 monoclonal antibody is permitted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Seville, Spain

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2016

First Posted

March 22, 2016

Study Start

June 1, 2016

Primary Completion

March 26, 2021

Study Completion

March 26, 2021

Last Updated

August 31, 2021

Record last verified: 2021-08

Locations

ES(3)US(7)