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A Study of ABT-165 in Subjects With Solid Tumors

NCT ID: NCT01946074

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-08

Study Completion Date

2022-09-28

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumors

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monotherapy

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

Group Type EXPERIMENTAL

ABT-165

Intervention Type DRUG

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

Cohort A

ABT-165 plus paclitaxel

Group Type EXPERIMENTAL

paclitaxel

Intervention Type DRUG

Paclitaxel will be administered by intravenous infusion.

ABT-165

Intervention Type DRUG

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

Cohort B

ABT-165 plus FOLFIRI

Group Type EXPERIMENTAL

FOLFIRI

Intervention Type DRUG

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

ABT-165

Intervention Type DRUG

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

Cohort C

ABT-165 plus ABBV-181

Group Type EXPERIMENTAL

ABT-165

Intervention Type DRUG

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

ABBV-181

Intervention Type DRUG

ABBV-181 will be administered by intravenous infusion.

Cohort D

ABT-165 plus ABBV-181 plus paclitaxel

Group Type EXPERIMENTAL

paclitaxel

Intervention Type DRUG

Paclitaxel will be administered by intravenous infusion.

ABT-165

Intervention Type DRUG

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

ABBV-181

Intervention Type DRUG

ABBV-181 will be administered by intravenous infusion.

Interventions

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paclitaxel

Paclitaxel will be administered by intravenous infusion.

Intervention Type DRUG

FOLFIRI

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

Intervention Type DRUG

ABT-165

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

Intervention Type DRUG

ABBV-181

ABBV-181 will be administered by intravenous infusion.

Intervention Type DRUG

Eligibility Criteria

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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.

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%.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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HonorHealth Research Institute - Pima /ID# 105677

Scottsdale, Arizona, United States

Site Status

Scottsdale Healthcare /ID# 105678

Scottsdale, Arizona, United States

Site Status

University of California, Los Angeles /ID# 141389

Los Angeles, California, United States

Site Status

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

Sacramento, California, United States

Site Status

Stanford University School of Med /ID# 123758

Stanford, California, United States

Site Status

Illinois Cancer Care, PC /ID# 151970

Peoria, Illinois, United States

Site Status

Horizon Oncology Research Center /ID# 138022

Lafayette, Indiana, United States

Site Status

Duke Cancer Center /ID# 105679

Durham, North Carolina, United States

Site Status

Tennessee Oncology-Nashville Centennial /ID# 143280

Nashville, Tennessee, United States

Site Status

Mary Crowley Cancer Research /ID# 123757

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34315767 (View on PubMed)

Other Identifiers

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M14-006

Identifier Type: -

Identifier Source: org_study_id