A Study of ABT-165 in Subjects With Solid Tumors

NCT01946074 | Completed Phase 1 FDA Drug

• 1 other identifier: M14-006
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Advanced Solid Tumors

Keywords

ABBV-181; ABT-165; cancer; neoplasm; advanced solid tumor; colorectal cancer

Outcome Measures

Primary Outcomes (8)

• Clinical lab testing

  Hematology, Chemistry, and Urinalysis

  Up to 30 days after a 24-month treatment period

• Maximum observed serum concentration (Cmax) of ABT-165

  Up to 90 days after a 24-month of treatment period

• The terminal elimination half life of ABT-165

  Up to 90 days after a 24-month treatment period

• Cardiac assessment

  Electrocardiogram (ECG), echocardiogram (ECHO), basic natriuretic peptide (BNP) and troponin I

  Up to 30 days after a 24-month treatment period

• 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

• Physical exam

  Assessment of normal/abnormal physical findings

  Up to 30 days after a 24-month treatment period

• Number of participants with Adverse Events

  Collect all adverse events at each visit

  Up to 90 days after a 24-month treatment period

• Vital signs

  Blood pressure, heart rate, respiratory rate and body temperature

  Up to 30 days after a 24-month treatment period

Secondary Outcomes (3)

• Duration of overall response (DOR)

  Up to 30 days after a 24-month treatment period

• Objective response rate (ORR)

  Up to 30 days after a 24-month treatment period

• Progression free survival (PFS)

  Up to 30 days after a 24-month treatment period

Study Arms (5)

Monotherapy

EXPERIMENTAL

ABT-165 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle). Additional subjects will be enrolled in an expansion cohort that will further evaluate ABT-165

Drug: ABT-165

Cohort A

EXPERIMENTAL

ABT-165 plus paclitaxel

Drug: paclitaxel; Drug: ABT-165

Cohort B

EXPERIMENTAL

ABT-165 plus FOLFIRI

Drug: FOLFIRI; Drug: ABT-165

Cohort C

EXPERIMENTAL

ABT-165 plus ABBV-181

Drug: ABT-165; Drug: ABBV-181

Cohort D

EXPERIMENTAL

ABT-165 plus ABBV-181 plus paclitaxel

Drug: paclitaxel; Drug: ABT-165; Drug: ABBV-181

Interventions

paclitaxel DRUG

Paclitaxel will be administered by intravenous infusion.

Cohort A; Cohort D

FOLFIRI DRUG

5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion.

Cohort B

ABT-165 DRUG

ABT-165 will be administered by intravenous infusion at escalating dose levels.

Cohort A; Cohort B; Cohort C; Cohort D; Monotherapy

ABBV-181 DRUG

ABBV-181 will be administered by intravenous infusion.

Cohort C; Cohort D

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (10)

HonorHealth Research Institute - Pima /ID# 105677

Scottsdale, Arizona, 85258-2345, United States

Location

Scottsdale Healthcare /ID# 105678

Scottsdale, Arizona, 85258-4566, United States

Location

University of California, Los Angeles /ID# 141389

Los Angeles, California, 90095, United States

Location

University of California, Davis Comprehensive Cancer Center /ID# 141164

Sacramento, California, 95817, United States

Location

Stanford University School of Med /ID# 123758

Stanford, California, 94305-2200, United States

Location

Illinois Cancer Care, PC /ID# 151970

Peoria, Illinois, 61615, United States

Location

Horizon Oncology Research Center /ID# 138022

Lafayette, Indiana, 47905, United States

Location

Duke Cancer Center /ID# 105679

Durham, North Carolina, 27710-3000, United States

Location

Tennessee Oncology-Nashville Centennial /ID# 143280

Nashville, Tennessee, 37203-1632, United States

Location

Mary Crowley Cancer Research /ID# 123757

Dallas, Texas, 75230, United States

Location

Related Publications (1)

• Gordon MS, Nemunaitis J, Barve M, Wainberg ZA, Hamilton EP, Ramanathan RK, Sledge GW Jr, Yue H, Morgan-Lappe SE, Blaney M, Kasichayanula S, Motwani M, Wang L, Naumovski L, Strickler JH. Phase I Open-Label Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Dilpacimab in Patients with Advanced Solid Tumors. Mol Cancer Ther. 2021 Oct;20(10):1988-1995. doi: 10.1158/1535-7163.MCT-20-0985. Epub 2021 Jul 26.

  PMID: 34315767 DERIVED

MeSH Terms

Conditions

Neoplasms; Colorectal Neoplasms

Interventions

Paclitaxel; IFL protocol; ABT-165; budigalimab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: September 19, 2013
• Study Start: August 8, 2013
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)