A Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR)

A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR)

Sponsors

Lead sponsor: AbbVie

Source AbbVie
Brief Summary

This is an open-label, Phase 1, dose-escalation study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-321 for participants with advanced solid tumors likely to overexpress the epidermal growth factor receptor (EGFR). The study will consist of 2 phases: Dose Escalation Phase and Expansion Phase.

Overall Status Recruiting
Start Date October 10, 2017
Completion Date September 4, 2025
Primary Completion Date March 7, 2024
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
AUCt for ABBV-321 Up to 78 days post dose
AUC∞ for ABBV-321 Up to 78 days post dose
Tmax of ABBV-321 Up to 78 days post dose
Terminal phase elimination rate constant (β) for ABBV-321 Up to 78 days post dose
Cmax of ABBV-321 Up to 78 days post dose
Dose Escalation Phase: Recommended Phase 2 dose (RPTD) for ABBV-321 Minimum first cycle of dosing (up to 28 days)
t1/2 for ABBV-321 Up to 78 days post dose
Dose Escalation Phase: Maximum tolerated dose (MTD) of ABBV-321 Minimum first cycle of dosing (up to 28 days)
Secondary Outcome
Measure Time Frame
Progression-Free Survival (PFS) Up to approximately 5 years
Duration of Response (DOR) Up to approximately 5 years
Disease Control Rate (DCR) Up to 5 years
Time to progression (TTP) Up to approximately 5 years
Change from Baseline in QTcF Up to 61 days post dose
Overall Survival (OS) Up to approximately 5 years
Objective response rate (ORR) Up to 5 years
Enrollment 120
Condition
Intervention

Intervention type: Drug

Intervention name: ABBV-321

Description: Intravenous infusion

Arm group label: ABBV-321

Other name: Serclutamab Talirine

Eligibility

Criteria:

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

- Histologically or cytologically confirmed solid tumor of one of the following types associated with overexpression of Epidermal Growth Factor Receptor (EGFR). (For Expansion Phase: Subjects must have EGFR overexpression demonstrated by central assessment or Sponsor selected test).

Dose Escalation Phase:

- Colorectal cancer (CRC), Glioblastoma (GBM), squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), bladder, cervical, esophageal, kidney or sarcoma.

- Participants must have disease that has progressed on prior treatment and is not amenable to surgical resection or other approved therapeutic options with curative intent. Participants must not be eligible for, or has refused further therapy that is likely to provide a survival benefit.

- Must have measureable disease as per RECIST Version 1.1 or RANO (for GBM).

- Minimum life expectancy of at least 12 weeks.

Expansion Phase (Solid Tumor Cohort):

- Histologically or cytologically confirmed advanced solid tumor.

- Participants must have disease that has progressed on prior treatment and is not amenable to surgical resection or other approved therapeutic options with curative intent.

- Must have measureable disease as per RECIST Version 1.1.

- Minimum life expectancy of at least 12 weeks.

Expansion Phase (GBM Cohort Only):

- Participant has recurrent primary (de novo) glioblastoma histologically confirmed at any time from initial diagnosis through latest recurrence.

- Participant has recurrent GBM per Response Evaluation in Neuro-Oncology (RANO) requirements.

- Tumor is measurable according to RANO criteria.

Exclusion Criteria:

- Active uncontrolled infection National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Grade greater than or equal to 3).

- New York Heart Association (NYHA) Class III or IV heart failure and/or ejection fraction of < 40% as measured by echocardiogram at screening.

- Unstable angina pectoris or cardiac ventricular arrhythmia.

- Myocardial infarction or cerebrovascular accident (CVA) within 6 months.

- Documented history of capillary leak syndrome within 6 months of study enrollment.

- Grade 2 or higher peripheral edema, ascites, pleural, or pericardial effusion within 4 weeks of study enrollment or any history of recurrent grade 2 or higher effusions requiring ongoing drainage.

- Active keratitis or current corneal disorder.

- Laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.

- Major surgery (including opening of the abdomen, chest) within 21 days of the first dose of study drug.

- Uncontrolled metastases from an extracranial solid tumor to the central nervous system (CNS). Participants with brain metastases from an extracranial solid tumor are eligible after definitive therapy provided they are asymptomatic for at least 2 weeks prior to first dose of ABBV-321.

- No history of medical condition resulting in nephrotic range proteinuria.

- Participants must not have been treated in anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal therapy, biologic therapy or investigational anti-cancer therapy within a period of 21 days or herbal anticancer therapy within 7 days prior to the first dose of study drug.

- For approved targeted small molecules, a washout period of 5 half-lives is adequate (no washout period required for subjects currently on erlotinib)

- Participant must not have been in more than three lines of systemic cytotoxic therapy (excluding adjuvant and neoadjuvant therapy)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

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
University of Arizona Cancer Center - Tucson /ID# 213220 | Tucson, Arizona, 85724, United States Not yet recruiting
Highlands Oncology Group /ID# 166132 | Fayetteville, Arkansas, 72703-4005, United States Recruiting
UCSD Moores Cancer Center - LaJolla /ID# 215366 | La Jolla, California, 92093, United States Not yet recruiting
The Angeles Clinic and Researc /ID# 166133 | Los Angeles, California, 90025, United States Recruiting
UC Davis Comprehensive Cancer Center - Main /ID# 215012 | Sacramento, California, 95817, United States Not yet recruiting
Cancer Specialists of North Florida - Southpoint /ID# 212940 | Jacksonville, Florida, 32256, United States Not yet recruiting
Northwestern University Feinberg School of Medicine /ID# 165191 | Chicago, Illinois, 60611-2927, United States Not yet recruiting
University of Chicago /ID# 166064 | Chicago, Illinois, 60637, United States Recruiting
Northshore University Health System-Evanston /ID# 201095 | Evanston, Illinois, 60201, United States Recruiting
Ingalls Memorial Hosp /ID# 214950 | Harvey, Illinois, 60426, United States Not yet recruiting
Massachusetts General Hospital /ID# 213173 | Boston, Massachusetts, 02114, United States Not yet recruiting
Beth Israel Deaconess Medical Center /ID# 213174 | Boston, Massachusetts, 02215-5400, United States Not yet recruiting
Dana-Farber Cancer Institute /ID# 212920 | Boston, Massachusetts, 02215, United States Not yet recruiting
Columbia Univ Med Ctr /ID# 167184 | New York, New York, 10032, United States Recruiting
Duke University Medical Center /ID# 166135 | Durham, North Carolina, 27710-3000, United States Recruiting
Lifespan Cancer Institute /ID# 168600 | Providence, Rhode Island, 02903-4923, United States Recruiting
South Texas Accelerated Research Therapeutics /ID# 166134 | San Antonio, Texas, 78229, United States Recruiting
Northern Cancer Institute /ID# 166138 | St Leonards, New South Wales, 2065, Australia Recruiting
Austin Hospital /ID# 166137 | Heidelberg, Victoria, 3084, Australia Recruiting
Sheba Medical Center /ID# 166398 | Ramat Gan, 5262100, Israel Recruiting
Location Countries

Australia

Israel

United States

Verification Date

November 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: ABBV-321

Arm group type: Experimental

Description: ABBV-321 will be administered via intravenous infusion at escalating dose levels until the maximum tolerated dose is reached and a recommended Phase 2 dose is determined.

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov