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

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

Sponsors

Lead Sponsor: AbbVie

Source 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.

Overall Status Recruiting
Start Date January 15, 2014
Completion Date February 9, 2022
Primary Completion Date February 9, 2022
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) Up to 24 months
Maximum observed plasma concentration (Cmax) Up to 24 months
Time to Cmax (Tmax) Up to 24 months
Terminal elimination half life Up to 24 months
Secondary Outcome
Measure Time Frame
Objective response rate (ORR) Up to 24 months
Progression free survival (PFS) Up to 24 months
Duration of overall response (DOR) Up to 24 months
Enrollment 225
Condition
Intervention

Intervention Type: Drug

Intervention Name: Osimertinib

Description: It is administered orally everyday.

Arm Group Label: Arm E (Telisotuzumab vedotin plus Osimertinib)

Intervention Type: Drug

Intervention Name: Nivolumab

Description: It is an intravenous infusion administered every 14 days.

Arm Group Label: Arm D (Telisotuzumab vedotin plus Nivolumab)

Intervention Type: Drug

Intervention Name: Telisotuzumab vedotin

Description: It is administered by infusion in 21-day dosing cycles.

Other Name: ABBV-399

Intervention Type: Drug

Intervention Name: Telisotuzumab vedotin

Description: It is administered by infusion in 28-day dosing cycles.

Other Name: ABBV-399

Intervention Type: Drug

Intervention Name: Erlotinib

Description: It is administered orally everyday.

Arm Group Label: Arm A (Telisotuzumab vedotin plus Erlotinib)

Eligibility

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
AbbVie Inc. Study Director AbbVie
Overall Contact

Last Name: ABBVIE CALL CENTER

Phone: 847.283.8955

Email: [email protected]

Location
Facility: Status:
Scottsdale Healthcare /ID# 123761 | Scottsdale, Arizona, 85258-4566, United States Completed
Cedars-Sinai Medical Center /ID# 216836 | Beverly Hills, California, 90211, United States Not yet recruiting
City of Hope /ID# 153759 | Duarte, California, 91010, United States Recruiting
University of California, Los Angeles /ID# 148295 | Los Angeles, California, 90095, United States Recruiting
UC Irvine /ID# 165107 | Orange, California, 92868, United States Recruiting
UC Davis Comprehensive Cancer Center - Main /ID# 129805 | Sacramento, California, 95817, United States Recruiting
Univ of Colorado Cancer Center /ID# 123759 | Aurora, Colorado, 80045, United States Recruiting
University of Chicago /ID# 136995 | Chicago, Illinois, 60637-1443, United States Recruiting
Ingalls Memorial Hosp /ID# 165876 | Harvey, Illinois, 60426, United States Completed
Massachusetts General Hospital /ID# 129804 | Boston, Massachusetts, 02114, United States Recruiting
Dana-Farber Cancer Institute /ID# 168782 | Boston, Massachusetts, 02215, United States Completed
Henry Ford Health System /ID# 149857 | Detroit, Michigan, 48202, United States Recruiting
Herbert Herman Cancer Center /ID# 149858 | Lansing, Michigan, 48912, United States Completed
Virginia Piper Cancer Institut /ID# 217418 | Minneapolis, Minnesota, United States Not yet recruiting
Washington University-School of Medicine /ID# 143798 | Saint Louis, Missouri, 63110, United States Completed
Duke University Medical Center /ID# 123763 | Durham, North Carolina, 27710-3000, United States Recruiting
Tennessee Oncology, PLLC /ID# 129802 | Nashville, Tennessee, 37203, United States Recruiting
Mary Crowley Cancer Research /ID# 123760 | Dallas, Texas, 75230, United States Recruiting
University of Texas MD Anderson Cancer Center /ID# 154648 | Houston, Texas, 77030, United States Recruiting
Virginia Cancer Specialists /ID# 165708 | Fairfax, Virginia, 22031, United States Recruiting
UZ Antwerpen /ID# 170118 | Edegem, 2650, Belgium Completed
Tays Keskussairaala /ID# 165065 | Tampere, 33520, Finland Completed
Gustave Roussy /ID# 132747 | Villejuif, Ile-de-France, 94805, France Recruiting
Hopital de la Timone /ID# 151570 | Marseille CEDEX 05, Provence-Alpes-Cote-d Azur, 13385, France Recruiting
IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 164077 | Meldola, Emilia-Romagna, 47014, Italy Completed
National Cancer Center Hospital East /ID# 217570 | Kashiwa-shi, Chiba, 277-8577, Japan Not yet recruiting
National Cancer Center Hospital /ID# 217571 | Chuo-ku, Tokyo, 104-0045, Japan Not yet recruiting
Severance Hospital /ID# 217333 | Seoul, 03722, Korea, Republic of Not yet recruiting
Asan Medical Center /ID# 217334 | Seoul, 05505, Korea, Republic of Not yet recruiting
China Medical University Hosp /ID# 217494 | Taichung City, Taichung, 40447, Taiwan Not yet recruiting
National Cheng Kung University Hospital /ID# 167175 | Tainan City, Tainan, 70403, Taiwan Recruiting
National Taiwan University Hospital /ID# 167173 | Taipei City, Taipei, 100, Taiwan Recruiting
Taipei Veterans General Hosp /ID# 217392 | Taipei City, 11217, Taiwan Not yet recruiting
Location Countries

Belgium

Finland

France

Italy

Japan

Korea, Republic of

Taiwan

United States

Verification Date

February 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: Arm E (Telisotuzumab vedotin plus Osimertinib)

Type: Experimental

Description: Telisotuzumab vedotin to be evaluated with Osimertinib.

Label: Arm D (Telisotuzumab vedotin plus Nivolumab)

Type: Experimental

Description: Telisotuzumab vedotin to be evaluated with Nivolumab.

Label: Monotherapy Telisotuzumab vedotin (21-day dosing cycles)

Type: Experimental

Description: Telisotuzumab vedotin 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 Telisotuzumab vedotin.

Label: Arm A (Telisotuzumab vedotin plus Erlotinib)

Type: Experimental

Description: Telisotuzumab vedotin to be evaluated with Erlotinib.

Label: Monotherapy Telisotuzumab vedotin (28-day dosing cycles)

Type: Experimental

Description: Telisotuzumab vedotin 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 Telisotuzumab vedotin.

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov