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Clinical Trials List

Protocol NumberM14-237
NCT Number(ClinicalTrials.gov Identfier)NCT02099058
Active

2018-01-05 - 2021-12-31

Phase I

Not yet recruiting1

Recruiting5

ICD-10C80

Malignant neoplasm without specification of site

A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

  • Trial Applicant

    AbbVie

  • Sponsor

    AbbVie

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Wei-Pang Chung Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Wei-Pang Chung Division of General Internal Medicine
National Cheng Kung University Hospital Dou-Liou Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Solid Tumors/NSCLC

Objectives

Primary:  to evaluate the safety and tolerability of ABBV-399 when administered as monotherapy and in combination with erlotinib, cetuximab, bevacizumab or nivolumab  to evaluate the pharmacokinetics (PK) of ABBV-399 (including Total ABT-700 and MMAE) when administered as monotherapy and in combination with erlotinib, cetuximab, bevacizumab or nivolumab  to determine the maximum tolerated and recommended Phase 2 dose (RPTD) for ABBV-399 when administered as monotherapy and in combination with erlotinib, cetuximab, bevacizumab or nivolumab Secondary:  to evaluate the preliminary efficacy of ABBV-399 when administered as monotherapy and in combination with erlotinib, cetuximab, bevacizumab or nivolumab

Test Drug

ABBV-399

Active Ingredient

ABBV-399

Dosage Form

Powder for Infusion Vial

Dosage

100

Endpoints

Efficacy: The efficacy endpoints include objective response rate (ORR) (determined using RECIST
version 1.1), progression-free survival (PFS), and duration of overall response (DOR).
Pharmacokinetic: Blood samples for assay of ABBV-399, Total ABT-700 and free MMAE drug levels
will be used to evaluate PK parameters. Values for the pharmacokinetic parameters including the
maximum observed plasma concentration (Cmax), the time to Cmax (Tmax), the area under the plasma
concentration-time curve (AUC), and terminal half-life (t1/2) will be determined using the noncompartmental methods.
Blood samples for antidrug antibody (ADA) and neutralizing ADA (nADA) will be collected at
designated time points throughout the study and ADA/nADA will be correlated with PK and safety
outcomes.
Additional parameters will be determined if deemed useful and appropriate.
Biomarkers: Exploratory research to find biomarkers that may serve as surrogates for clinical endpoints
in future ABBV-399 studies or that may be predictive of ABBV-399 activity or safety will be conducted.
Plasma, serum, and tissues samples (archived or pre- and on-treatment fresh biopsy and postprogression) will be collected during the study.
Safety: Adverse events, laboratory profiles, physical exams, and vital signs will be assessed throughout
the study. Adverse events will be graded according the National Cancer Institute Common Terminology
Criteria for Adverse Events (NCI CTCAE), version 4.03.

Inclution Criteria

 Subject must be ≥ 18 years of age
 Subject with advanced solid tumor including but not limited to non-small cell lung cancer
(NSCLC), colorectal, breast, ovarian, esophageal/gastric and head and neck cancer.
 Subject must have advanced solid tumor that is not amenable to surgical resection or other
approved therapeutic options that have demonstrated clinical benefit.
o Subjects who have refused, are considered ineligible for or are intolerant of standard
therapy are eligible.
o Based on evidence gathered in this study or from external sources, the Sponsor in
consultation with the Investigators, may decide to limit to specific tumor types.
o For dose-expansion: Subject must have tumor with c-Met overexpression, MET exon 14
mutation or MET amplification.
 Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
 Subject must have measurable disease per RECIST version 1.1 (Appendix C).
 Subject has archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue
available for analysis.
o If a subject has local or central lab data showing c-Met overexpression, MET exon 14
mutation or MET amplification and no archival tumor tissue available, the subject may be
eligible after discussion with the Medical Monitor.
 Subject has adequate bone marrow, renal, and hepatic function as follows:
o Bone marrow: Absolute neutrophil count (ANC) ≥ 1,500/mm3
, Platelets ≥ 100,000/mm3
;
Hemoglobin ≥ 9.0 g/dL.
o Renal function: Serum creatinine ≤ 1.5 × the institution's ULN range or creatinine
clearance ≥ 50 mL/min measured by 24-hour urine or estimated by the Cockcroft-Gault
formula.
o Hepatic function: Bilirubin ≤ 1.0 × ULN, aspartate aminotransferase (AST), alanine
aminotransferase (ALT) ≤ 2.5 × ULN and albumin ≥ 3.0 g/dL.
 Women of childbearing potential must have a negative serum pregnancy test within 14 days
prior to initiation of treatment. Subjects with initial positive serum pregnancy tests are eligible
if it is determined through other means that the subject is not pregnant (i.e., ultrasound in cases
where tumor is suspected of secreting β-HCG and resulting in a false-positive pregnancy test).
Female subjects considered not of childbearing potential must be documented as being
surgically sterile or post-menopausal for at least 1 year. Women of childbearing potential and
men must agree to use adequate contraception (one of the following listed below-refer to
Section 5.2.1 for complete list) prior to study entry, for the duration of study participation and
for a period of 6 months after the last dose of study drug.
o Vasectomy (a vasectomized male subject or a vasectomized partner of a female subject) for
at least 3 months prior to study drug administration.
o Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to
study drug administration.
o Barrier method of contraception (condom or occlusive cap (diaphragm or cervical/vault
caps) with spermicidal foam/gel/film/cream/suppository).
 Subject is capable of understanding and complying with parameters as outlined in the protocol
and able to sign informed consent, approved by an Institutional Review Board (IRB) prior to the
initiation of any screening or study-specific procedures.
Additional Inclusion Criteria for Subjects Enrolled on the Combination Therapy Phase
Subjects in the combination therapy arms must meet the above inclusion criteria and be eligible to
receive erlotinib, cetuximab, bevacizumab or nivolumab per most current prescribing information, or at
the discretion of the Investigator

Exclusion Criteria

For All Cohorts:
 Subject has received anticancer therapy including chemotherapy, immunotherapy, 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.
o Palliative radiation therapy for painful bone, skin or subcutaneous metastases for
10 fractions or less is not subject to a washout period; see below for central nervous system
metastases (CNS).
o For approved targeted small molecules, a washout period of 5 half-lives is adequate (no
washout period required for subjects currently on erlotinib).
 Subject has known uncontrolled metastases to the CNS. Subjects with brain metastases are
eligible after definitive therapy provided they are asymptomatic off steroids and anticonvulsants
for at least 2 weeks prior to first dose of ABBV-399.
 Subject has unresolved clinically significant adverse events ≥ Grade 2 from prior anticancer
therapy except for alopecia or anemia.
 Subject has had major surgery within 21 days prior to the first dose of ABBV-399.
Additional Exclusion Criteria for Subjects Enrolled on the Combination Therapy Phase
 Subject has a clinically significant uncontrolled condition(s) including but not limited to the
following:
o Grade ≥ 2 peripheral edema or lymphedema.
o Grade ≥ 2 ascites or pleural effusion.
o Grade ≥ 2 peripheral neuropathy.
o Active uncontrolled bacterial or viral infection.
o Symptomatic congestive heart failure.
o Unstable angina pectoris or cardiac arrhythmia.
o Extensive metastatic liver disease involving ≥ 50% of the liver in the judgment of the
Investigator or Medical Monitor.
o Psychiatric illness/social situation that would limit compliance with the study.
 Subject has history of major immunologic reaction to any IgG containing agent.
 Subject has any medical condition which in the opinion of the Investigator or Medical Monitor
places the subject at an unacceptably high risk for toxicities.
 Subject is a lactating or pregnant female.
 Subjects enrolled on the combination therapy phase must satisfy the above exclusion criteria
and also the following:
o Subjects may not receive ABBV-399 in combination with erlotinib, cetuximab,
bevacizumab or nivolumab if they have any medical condition which in the opinion of the
Investigator places the subject at an unacceptably high risk for toxicities from the
combination.
 Subjects may not receive cetuximab if they have K-ras mutation.
 Subjects may not receive bevacizumab if they have squamous NSCLC.
 Subjects may not receive nivolumab if they have:
o Active autoimmune disease with exceptions of vitiligo, type I diabetes mellitus,
hypothyroidism and psoriasis
o Used systemic corticosteroids (> 10 mg daily prednisone or equivalent) or other
immunosuppressive medications within 14 days of study drug administration,
with exception of inhaled or topical steroids
o Known immunosuppressive disease, for example, human immunodeficiency
virus infection or history of bone marrow transplant or chronic lymphocytic
leukemia

The Estimated Number of Participants

  • Taiwan

    10 participants

  • Global

    260 participants

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