A Study of ABT-165 in Subjects With Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABT-165, a Dual Variable Domain Immunoglobulin in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946074
• Other study ID #: M14-006
• Status: Completed
• Phase: Phase 1
• Start date: August 8, 2013
• Est. completion date: September 28, 2022

Study information

• Verified date: December 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-165 when administered as monotherapy and in combination with paclitaxel or 5-fluoruracil, folinic acid and irinotecan (FOLFIRI) or ABBV-181 with/without paclitaxel in subjects with advanced solid tumors. Enrollment to Cohorts A, B were completed and for Cohorts C and D are recruiting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 28, 2022
• Est. primary completion date: September 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Subject must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.

• Subject has adequate bone marrow, renal, hepatic and coagulation function.

• Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or disease evaluable by assessment of tumor antigens including but not limited to cancer antigen (CA-125) and prostate-specific antigen (PSA).

• Women of childbearing potential must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at baseline prior to the first dose of study drug. Female subject 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.

• Subjects in the combination therapy cohorts must meet the above inclusion criteria and be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator. Subjects in the combination therapy cohorts who are to receive ABBV-181, an anti-PD1 antibody, must also meet other criteria described in the Protocol.

Exclusion Criteria:

• Subject has received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days or anti-cancer herbal therapy within 7 days prior to Cycle 1 Day 1 of ABT-165.

• Subject has uncontrolled metastases to the central nervous system (CNS).

• Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.

• Subject has history (within previous 5 years) of clinically significant pulmonary hypertension, uncontrolled systemic hypertension or hypertensive crisis, symptomatic heart failure, cardiomyopathy, myocardial infarction, unstable/severe angina pectoris, cardiac arrhythmia requiring medication, coronary/peripheral artery bypass graft, aneurysm or aneurysm repair, angioplasty, cerebrovascular accident, transient ischemic attack or the left ventricular ejection fraction (LVEF) less than 50%.

• Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator. Subjects receiving ABBV-181 must not meet other exclusion criteria described in the Protocol.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• paclitaxel
Paclitaxel will be administered by intravenous infusion.
• FOLFIRI
5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion.
• ABT-165
ABT-165 will be administered by intravenous infusion at escalating dose levels.
• ABBV-181
ABBV-181 will be administered by intravenous infusion.

Locations

Country	Name	City	State
United States	Mary Crowley Cancer Research /ID# 123757	Dallas	Texas
United States	Duke Cancer Center /ID# 105679	Durham	North Carolina
United States	Horizon Oncology Research Center /ID# 138022	Lafayette	Indiana
United States	University of California, Los Angeles /ID# 141389	Los Angeles	California
United States	Tennessee Oncology-Nashville Centennial /ID# 143280	Nashville	Tennessee
United States	Illinois Cancer Care, PC /ID# 151970	Peoria	Illinois
United States	University of California, Davis Comprehensive Cancer Center /ID# 141164	Sacramento	California
United States	HonorHealth Research Institute - Pima /ID# 105677	Scottsdale	Arizona
United States	Scottsdale Healthcare /ID# 105678	Scottsdale	Arizona
United States	Stanford University School of Med /ID# 123758	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical lab testing	Hematology, Chemistry, and Urinalysis	Up to 30 days after a 24-month treatment period
Primary	Maximum observed serum concentration (Cmax) of ABT-165		Up to 90 days after a 24-month of treatment period
Primary	The terminal elimination half life of ABT-165		Up to 90 days after a 24-month treatment period
Primary	Cardiac assessment	Electrocardiogram (ECG), echocardiogram (ECHO), basic natriuretic peptide (BNP) and troponin I	Up to 30 days after a 24-month treatment period
Primary	Area under the curve (AUC) form time zero to the last measurable concentration AUC (0-t)	AUC (0-t) = Area under the serum concentration versus time curve form time zero (pre-dose) to the time of the last measurable concentration	Up to 90 days after a 24-month treatment period
Primary	Physical exam	Assessment of normal/abnormal physical findings	Up to 30 days after a 24-month treatment period
Primary	Number of participants with Adverse Events	Collect all adverse events at each visit	Up to 90 days after a 24-month treatment period
Primary	Vital signs	Blood pressure, heart rate, respiratory rate and body temperature	Up to 30 days after a 24-month treatment period
Secondary	Duration of overall response (DOR)	DOR is defined as the time from the subject's initial CR or PR to the time of disease progression	Up to 30 days after a 24-month treatment period
Secondary	Objective response rate (ORR)	ORR is defined as the proportion of the subjects who have a complete response (CR) or partial response (PR)	Up to 30 days after a 24-month treatment period
Secondary	Progression free survival (PFS)	PFS is defined as the time from the first dose date of ABT-165 to either disease progression or death, whichever occurs first	Up to 30 days after a 24-month treatment period