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A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously Treated Solid Tumors and Hematologic Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT03082209
First received: March 14, 2017
Last updated: March 30, 2017
Last verified: March 2017
  Purpose
This is an open-label, Phase I, dose-escalation study to determine the determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD), and evaluate the safety, efficacy, and pharmacokinetic (PK) profile of ABBV-621 for participants with previously treated solid tumors or hematologic malignancies. The study will consist of 2 segments: Segment I (Dose Escalation) and Segment II (Dose Expansion).

Condition Intervention Phase
Solid Tumors
Hematologic Malignancies
Drug: ABBV-621
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 1, First-In-Human Study of Safety and Tolerability of TRAIL Receptor Agonist ABBV-621 in Subjects With Previously Treated Solid Tumors and Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Segment 1: Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) for ABBV-621 [ Time Frame: Up to 21 days ]
    The MTD and/or RP2D of ABBV-621 will be determined during the dose escalation phase (Segment I) of the study.

  • Segment 1: Maximum observed serum concentration (Cmax) of ABBV-621 [ Time Frame: Up to 64 days ]
    Maximum observed serum concentration (Cmax) of ABBV-621.

  • Segment 1: Area under the serum concentration time curve (AUC) of ABBV-621 [ Time Frame: Up to 64 days ]
    Area under the serum concentration time curve (AUC) of ABBV-621.

  • Segment 2: Objective response rate (ORR) [ Time Frame: Approximately 6 months ]
    ORR is defined as the proportion of participants with a response of partial response (PR) or better per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for colorectal cancer (CRC) and other solid tumor participants, or per the International Working Group (IWG) criteria for Acute Myeloid Leukemia (AML) participants, or per the Lugano response criteria for Non-Hodgkin Lymphoma (NHL) participants.

  • Segment 1: Terminal phase elimination rate constant (β) [ Time Frame: Up to 64 days ]
    Terminal phase elimination rate constant (β).

  • Segment 1: Time to Cmax (Tmax) of ABBV-621 [ Time Frame: Up to 64 days ]
    Time to Cmax (Tmax) of ABBV-621.


Secondary Outcome Measures:
  • Segment 2: Dose limiting toxicity (DLT) [ Time Frame: Up to 21 days after first day of study drug administration ]
    A drug-related toxicity is an adverse event or laboratory value outside of the reference range that is judged by the Investigator and/or the AbbVie as a "reasonable possibility" of being related to the study drug.

  • QTcF Change from Baseline [ Time Frame: Up to 64 days ]
    QT interval measurement corrected by Fridericia's formula (QTcF) mean change from baseline by dose level


Estimated Enrollment: 92
Actual Study Start Date: March 29, 2017
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Escalating Arm 1
ABBV-621 via intravenous administration at escalating dose levels in participants with solid tumors.
Drug: ABBV-621
Intravenous
Experimental: Escalating Arm 2
ABBV-621 via intravenous administration at escalating dose levels in participants with acute myeloid leukemia (AML).
Drug: ABBV-621
Intravenous
Experimental: Expansion Arm 1
Additional participants with solid tumors will be enrolled in a dose expansion cohort that will further evaluate ABBV-621.
Drug: ABBV-621
Intravenous
Experimental: Expansion Arm 2
Additional participants with colorectal cancer (CRC) will be enrolled in a dose expansion cohort that will further evaluate ABBV-621.
Drug: ABBV-621
Intravenous
Experimental: Expansion Arm 3
Additional participants with AML will be enrolled in a dose expansion cohort that will further evaluate ABBV-621.
Drug: ABBV-621
Intravenous

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have a diagnosis of a solid tumor, AML or non-Hodgkin lymphoma (NHL) that has relapsed, progressed, or failed to respond after at least one systemic therapy.
  • Must have measurable disease, as defined by RECIST 1.1, by computed tomography (CT) or magnetic resonance imaging (MRI), except those with AML, who must have histologically confirmed relapsed or refractory disease at the local institution.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 - 2.
  • Must have adequate hematologic, renal and hepatic function.

Exclusion Criteria:

  • Participants with history of brain metastases who have not shown clinical and radiographic stable disease for at least 28 days after definitive therapy.
  • Receipt of any systemic anti-cancer agent, including investigational anti-cancer products, within 21 days prior to study drug administration or 5 half-lives, whichever is longer.
  • Participant with a history of cirrhosis or other indication of significant hepatic function compromise.
  • Participant with a positive diagnosis of hepatitis A, B, or C.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03082209

Contacts
Contact: AbbVie_Call Center 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
United States, Connecticut
Yale Cancer Center /ID# 158029 Not yet recruiting
New Haven, Connecticut, United States, 06520
United States, Texas
South Texas Accelerated Research Therapeutics, LLC /ID# 160574 Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03082209     History of Changes
Other Study ID Numbers: M15-913
2016-003887-37 ( EudraCT Number )
Study First Received: March 14, 2017
Last Updated: March 30, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AbbVie:
non-Hodgkin lymphoma
Solid Tumors
acute myeloid leukemia (AML)
Cancer
Hematologic Malignancies
colorectal cancer (CRC)

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 28, 2017