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Advanced Solid TumorsPhase 1NCT01946074

A Study of ABT-165 in Subjects With Solid Tumors

A Phase 1 study testing paclitaxel, FOLFIRI and ABT-165 in people with Advanced Solid Tumors, run by AbbVie at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
paclitaxel, FOLFIRI and ABT-165
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
10 sitesUnited States
Study dates
8 Aug 2013to 28 Sep 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Mary Crowley Cancer Research /ID# 123757

    Dallas, Texas, 75230

  • Duke Cancer Center /ID# 105679

    Durham, North Carolina, 27710-3000

  • Horizon Oncology Research Center /ID# 138022

    Lafayette, Indiana, 47905

  • University of California, Los Angeles /ID# 141389

    Los Angeles, California, 90095

  • Tennessee Oncology-Nashville Centennial /ID# 143280

    Nashville, Tennessee, 37203-1632

  • Illinois Cancer Care, PC /ID# 151970

    Peoria, Illinois, 61615

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

    Sacramento, California, 95817

  • HonorHealth Research Institute - Pima /ID# 105677

    Scottsdale, Arizona, 85258-2345

  • Scottsdale Healthcare /ID# 105678

    Scottsdale, Arizona, 85258-4566

  • Stanford University School of Med /ID# 123758

    Stanford, California, 94305-2200

Other trials in United States

About this study

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

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.

Being tested
paclitaxel, FOLFIRI, ABT-165, ABBV-181
Keywords
ABBV-181, ABT-165, cancer, neoplasm, advanced solid tumor, colorectal cancer
Medical subject headings
Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • paclitaxelDrug

    Paclitaxel will be administered by intravenous infusion.

  • FOLFIRIDrug

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

  • ABT-165Drug

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

  • ABBV-181Drug

    ABBV-181 will be administered by intravenous infusion.

Study groups in NCT01946074
Study groupRoleWhat they receive
MonotherapyExperimentalABT-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
Receives: Drug: ABT-165
Cohort AExperimentalABT-165 plus paclitaxel
Receives: Drug: paclitaxel; Drug: ABT-165
Cohort BExperimentalABT-165 plus FOLFIRI
Receives: Drug: FOLFIRI; Drug: ABT-165
Cohort CExperimentalABT-165 plus ABBV-181
Receives: Drug: ABT-165; Drug: ABBV-181
Cohort DExperimentalABT-165 plus ABBV-181 plus paclitaxel
Receives: Drug: paclitaxel; Drug: ABT-165; Drug: ABBV-181

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical lab testing

    Hematology, Chemistry, and Urinalysis

    Measured: Up to 30 days after a 24-month treatment period

  2. Maximum observed serum concentration (Cmax) of ABT-165

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

  3. The terminal elimination half life of ABT-165

    Measured: Up to 90 days after a 24-month treatment period

  4. Cardiac assessment

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

    Measured: Up to 30 days after a 24-month treatment period

  5. 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

    Measured: Up to 90 days after a 24-month treatment period

  6. Physical exam

    Assessment of normal/abnormal physical findings

    Measured: Up to 30 days after a 24-month treatment period

  7. Number of participants with Adverse Events

    Collect all adverse events at each visit

    Measured: Up to 90 days after a 24-month treatment period

  8. Vital signs

    Blood pressure, heart rate, respiratory rate and body temperature

    Measured: Up to 30 days after a 24-month treatment period

Secondary outcomes (3)

  1. 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

    Measured: Up to 30 days after a 24-month treatment period

  2. Objective response rate (ORR)

    ORR is defined as the proportion of the subjects who have a complete response (CR) or partial response (PR)

    Measured: Up to 30 days after a 24-month treatment period

  3. 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

    Measured: Up to 30 days after a 24-month treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2013 (estimated)
  2. Study start8 Aug 2013
  3. Primary completion28 Sep 2022
  4. Study completion28 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01946074
Sponsor's protocol ID
M14-006
Status last verified
Dec 2023
First submitted
17 Sep 2013
Last updated
15 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34315767

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing paclitaxel, FOLFIRI and ABT-165 in people with Advanced Solid Tumors, run by AbbVie at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical lab testing (time frame: Up to 30 days after a 24-month treatment period). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01946074, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.

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