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A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Subjects With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02099058
Recruitment Status : Recruiting
First Posted : March 28, 2014
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 as monotherapy and in combination with osimertinib, erlotinib, and nivolumab in subjects with advanced solid tumors likely to express c-Met. Enrollment is closed for the monotherapy arms, Arm A, and Arm D.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Cancer Drug: Osimertinib Drug: Nivolumab Drug: ABBV-399 Drug: Erlotinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
Actual Study Start Date : January 15, 2014
Estimated Primary Completion Date : December 10, 2020
Estimated Study Completion Date : April 20, 2021

Arm Intervention/treatment
Experimental: Arm E (ABBV-399 plus Osimertinib)
ABBV-399 to be evaluated with Osimertinib.
Drug: Osimertinib
It is administered orally everyday.

Drug: ABBV-399
It is administered by infusion in 28-day dosing cycles.

Experimental: Arm D (ABBV-399 plus Nivolumab)
ABBV-399 to be evaluated with Nivolumab.
Drug: Nivolumab
It is an intravenous infusion administered every 14 days.

Drug: ABBV-399
It is administered by infusion in 28-day dosing cycles.

Experimental: Monotherapy ABBV-399 (21-day dosing cycles)
ABBV-399 will be administered at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate ABBV-399.
Drug: ABBV-399
It is administered by infusion in 21-day dosing cycles.

Experimental: Arm A (ABBV-399 plus Erlotinib)
ABBV-399 to be evaluated with Erlotinib.
Drug: ABBV-399
It is administered by infusion in 21-day dosing cycles.

Drug: Erlotinib
It is administered orally everyday.

Experimental: Monotherapy ABBV-399 (28-day dosing cycles)
ABBV-399 will be administered at escalating dose levels in 28-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate ABBV-399.
Drug: ABBV-399
It is administered by infusion in 28-day dosing cycles.




Primary Outcome Measures :
  1. Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) [ Time Frame: Up to 24 months ]
    AUC (0-t) = Area under the serum concentration versus time curve from time zero (pre-dose) to the time of the last measurable concentration.

  2. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 24 months ]
    Maximum observed plasma concentration (Cmax)

  3. Time to Cmax (Tmax) [ Time Frame: Up to 24 months ]
    Time to Cmax (Tmax)

  4. Terminal elimination half life [ Time Frame: Up to 24 months ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to 24 months ]
    ORR is defined as the proportion of the subjects who have a complete response (CR) or partial response (PR).

  2. Progression free survival (PFS) [ Time Frame: Up to 24 months ]
    PFS is defined as the time from the first dose date of ABBV-399 to either disease progression or death, whichever occurs first.

  3. Duration of overall response (DOR) [ Time Frame: Up to 24 months ]
    DOR is defined as the time from the subject's initial CR or PR to the time of disease progression.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must have advanced Non-Small Cell Lung Cancer (NSCLC) that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  • Participant must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
  • Participant has fresh and/or archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue confirmed available for analyses.
  • Participant has adequate bone marrow, renal, and hepatic function.
  • Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment.
  • Participants in the combination therapy arms A and D must be eligible to receive erlotinib, or nivolumab per most current prescribing information, or at the discretion of the Investigator.
  • Participants in the combination therapy Arm E must satisfy following criteria.

    • Participant must have metastatic NSCLC with documented Epidermal Growth Factor Receptor (EGFR) mutation(s) known to be sensitive to osimertinib, including del19, L858R, G719X or L861Q.
    • Participant must have discontinued osimertinib due to disease progression.
    • Participant must have available post-progression tumor tissue for central c-Met immunohistochemistry (IHC) testing.

Exclusion Criteria:

  • Participant has received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days or herbal therapy within 7 days prior to the first dose of ABBV-399.
  • Participant has uncontrolled metastases to the central nervous system (CNS) based on head CT or MRI. Subjects with brain metastases may be eligible 2 weeks after definitive therapy to all known sites of CNS disease provided they are asymptomatic and either off or on a non-increasing dose (in last 2 weeks) of systemic steroids and not on anticonvulsants for seizure activity directly related to progressive CNS metastases.
  • Participant has history of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis.
  • Participant has unresolved clinically significant adverse events >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
  • Participant has had major surgery within 21 days prior to the first dose of ABBV-399.
  • Participant has a clinically significant condition(s) described in the protocol.
  • Participant has history of major immunologic reaction to any Immunoglobulin G (IgG) containing agent.
  • Participants enrolled on the combination therapy phase must satisfy the above exclusion criteria and also the following:
  • Participants may not receive ABBV-399 in combination with osimertinib, erlotinib or nivolumab if they have any medical condition which in the opinion of the Investigator places the participant at an unacceptably high risk for toxicities from the combination.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099058


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02099058     History of Changes
Other Study ID Numbers: M14-237
2014-003154-14 ( EudraCT Number )
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Cancer
Advanced Solid Tumor
Neoplasm
Additional relevant MeSH terms:
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Neoplasms
Nivolumab
Erlotinib Hydrochloride
Osimertinib
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs