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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.
Verified November 2017 by AbbVie
Sponsor:
ClinicalTrials.gov Identifier:
NCT03082209
First Posted: March 17, 2017
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie
March 14, 2017
March 17, 2017
December 4, 2017
March 29, 2017
November 16, 2018   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT03082209 on ClinicalTrials.gov Archive Site
  • 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 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
  • 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
Not Provided
Not Provided
 
A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously Treated Solid Tumors and Hematologic Malignancies
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
This is an open-label, Phase I, dose-escalation study to 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).
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Solid Tumors
  • Hematologic Malignancies
Drug: ABBV-621
Intravenous
  • Experimental: Escalating Arm 1
    ABBV-621 via intravenous administration at escalating dose levels in participants with solid tumors.
    Intervention: Drug: ABBV-621
  • Experimental: Escalating Arm 2
    ABBV-621 via intravenous administration at escalating dose levels in participants with acute myeloid leukemia (AML).
    Intervention: Drug: ABBV-621
  • Experimental: Expansion Arm 1
    Additional participants with solid tumors will be enrolled in a dose expansion cohort that will further evaluate ABBV-621.
    Intervention: Drug: ABBV-621
  • Experimental: Expansion Arm 2
    Additional participants with colorectal cancer (CRC) will be enrolled in a dose expansion cohort that will further evaluate ABBV-621.
    Intervention: Drug: ABBV-621
  • Experimental: Expansion Arm 3
    Additional participants with AML will be enrolled in a dose expansion cohort that will further evaluate ABBV-621.
    Intervention: Drug: ABBV-621
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
92
April 29, 2020
November 16, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must have a diagnosis of a solid tumor, AML or non-Hodgkin lymphoma (NHL).
  • Must have received at least one prior systemic therapy, and must have relapsed or progressed after, or failed to respond to any/all available effective therapy or therapies.
  • Must have measurable disease (by RECIST 1.1 for those with solid tumors; by Lugano classification for those with NHL), except those with AML, who must have histologically confirmed relapsed or refractory disease.
  • 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 including primary hepatobiliary malignancy (cholangiocarcinoma or hepatocellular carcinoma).
  • Participant with a positive diagnosis of hepatitis A, B, or C.
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Senior)
No
Contact: AbbVie_Call Center 847.283.8955 abbvieclinicaltrials@abbvie.com
Japan,   Netherlands,   Spain,   United States
 
 
NCT03082209
M15-913
2016-003887-37 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
AbbVie
AbbVie
Not Provided
Study Director: AbbVie Inc AbbVie
AbbVie
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP