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Advanced Solid Tumors CancerPhase 1NCT03234712

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)

A Phase 1 study testing ABBV-321 in people with Advanced Solid Tumors Cancer, run by AbbVie at 18 sites in 3 countries.

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 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors Cancer
What is being tested?
ABBV-321
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
18 sitesin 3 countries
Study dates
10 Oct 2017to 14 Apr 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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)

Trial locations and contacts

18 sites in 3 countries.

18 sites in 3 countries

United States14 sites

  • Dana-Farber Cancer Institute /ID# 212920

    Boston, Massachusetts, 02215

  • Northwestern University Feinberg School of Medicine /ID# 165191

    Chicago, Illinois, 60611-2927

  • University of Chicago /ID# 166064

    Chicago, Illinois, 60637

  • Duke University Medical Center /ID# 166135

    Durham, North Carolina, 27710-3000

  • University of Kentucky Markey Cancer Center /ID# 217665

    Lexington, Kentucky, 40536-7001

  • The Angeles Clinic and Researc /ID# 166133

    Los Angeles, California, 90025

  • Columbia Univ Medical Center /ID# 167184

    New York, New York, 10032-3725

  • Lifespan Cancer Institute at Rhode Island Hospital /ID# 168600

    Providence, Rhode Island, 02903-4923

  • University of California, Davis Comprehensive Cancer Center /ID# 215012

    Sacramento, California, 95817

  • South Texas Accelerated Research Therapeutics /ID# 166134

    San Antonio, Texas, 78229

  • Northshore University Health System Dermatology Clinical Trials Unit /ID# 201095

    Skokie, Illinois, 60077

  • Highlands Oncology Group /ID# 166132

    Springdale, Arkansas, 72762

  • Washington University-School of Medicine /ID# 214955

    St Louis, Missouri, 63110

  • Stony Brook University Hospital /ID# 216976

    Stony Brook, New York, 11794-8183

Other trials in United States

Australia3 sites

  • Monash Health /ID# 217435

    Clayton, Victoria, 3168

  • Austin Hospital /ID# 166137

    Heidelberg, Victoria, 3084

  • Northern Cancer Institute /ID# 166138

    St Leonards, New South Wales, 2065

Other trials in Australia

Israel1 site

  • Sheba Medical Center /ID# 166398

    Ramat Gan, 5239424

Other trials in Israel

About this study

Official title: 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)

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.

Being tested
ABBV-321
Keywords
Advanced Solid Tumors, Epidermal Growth Factor Receptor (EGFR), Squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), Glioblastoma (GBM), Cancer, overexpression of Epidermal Growth Factor Receptor (EGFR)
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Glioblastoma, Neoplasms

What participants receive

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

  • ABBV-321Drug

    Also called Serclutamab Talirine

    Intravenous infusion

Study groups in NCT03234712
Study groupRoleWhat they receive
ABBV-321ExperimentalABBV-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.
Receives: Drug: ABBV-321

What is being measured

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

  1. AUCt for ABBV-321

    Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCt) for ABBV-321

    Measured: Up to 78 days post dose

  2. AUC∞ for ABBV-321

    AUC∞ is the area under the plasma concentration-time curve from Time 0 to infinite time.

    Measured: Up to 78 days post dose

  3. Tmax of ABBV-321

    Time to Cmax (Tmax) of ABBV-321

    Measured: Up to 78 days post dose

  4. Terminal phase elimination rate constant (β) for ABBV-321

    Terminal phase elimination rate constant (β)

    Measured: Up to 78 days post dose

  5. Cmax of ABBV-321

    Maximum observed plasma concentration (Cmax) of ABBV-321

    Measured: Up to 78 days post dose

  6. Dose Escalation Phase: Recommended Phase 2 dose (RPTD) for ABBV-321

    The RPTD will be determined using available safety and pharmacokinetics data upon completion of the Dose Escalation Phase

    Measured: Minimum first cycle of dosing (up to 28 days)

  7. t1/2 for ABBV-321

    Terminal elimination half-life (t1/2)

    Measured: Up to 78 days post dose

  8. Dose Escalation Phase: Maximum tolerated dose (MTD) of ABBV-321

    The MTD of ABBV-321 will be determined during the dose escalation phase of the study.

    Measured: Minimum first cycle of dosing (up to 28 days)

Secondary outcomes (7)

  1. Progression-Free Survival (PFS)

    PFS is defined as the number of days from the first dose date to the earliest date of disease progression per RECIST 1.1 or RANO criteria or death, whichever occurred first.

    Measured: Up to approximately 5 years

  2. Duration of Response (DOR)

    DOR for a given participant is defined as the number of days from the day CR or PR (whichever is recorded first) occurred to the earliest date of disease progression per RECIST 1.1 or RANO criteria or death, whichever occurred first.

    Measured: Up to approximately 5 years

  3. Disease Control Rate (DCR)

    DCR is defined as the proportion of participants with objective evidence of complete response (CR), partial response (PR) or stable disease (SD); a participants best overall response assignment of SD must be maintained for at least 6 weeks since the first dose date of study drug.

    Measured: Up to 5 years

  4. Time to progression (TTP)

    TTP is defined as the number of days from the first dose date to the earliest date of disease progression per RECIST version 1.1 or RANO criteria.

    Measured: Up to approximately 5 years

  5. Change from Baseline in QTcF

    QT interval measurement corrected by Fridericia's formula (QTcF) change from baseline

    Measured: Up to 61 days post dose

  6. Overall Survival (OS)

    OS is defined as number of days from the date of the first dose to the date of death for all dosed participants. For participants who are not deceased, the data will be censored at the last known date to be alive.

    Measured: Up to approximately 5 years

  7. Objective response rate (ORR)

    ORR is defined as the proportion of participants with a response of partial response (PR) or better; Response Assessment in Neuro-Oncology (RANO) criteria will be used for glioblastoma (GBM) participants, and Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria will be used for all other participants.

    Measured: Up to 5 years

Timeline

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

  1. First posted31 Jul 2017
  2. Study start10 Oct 2017
  3. Primary completion14 Apr 2021
  4. Study completion14 Apr 2021

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03234712
Sponsor's protocol ID
M16-438
Status last verified
May 2021
First submitted
27 Jul 2017
Last updated
6 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Carneiro BA, Papadopoulos KP, Strickler JH, Lassman AB, Waqar SN, Chae YK, Patel JD, Shacham-Shmueli E, Kelly K, Khasraw M, Bestvina CM, Merrell R, Huang K, Atluri H, Ansell P, Li R, Jin J, Anderson MG, Reilly EB, Morrison-Thiele G, Patel K, Robinson RR, Aristide MRN, Gan HK. Phase I study of anti-epidermal growth factor receptor antibody-drug conjugate serclutamab talirine: Safety, pharmacokinetics, and antitumor activity in advanced glioblastoma. Neurooncol Adv. 2022 Dec 21;5(1):vdac183. doi: 10.1093/noajnl/vdac183. eCollection 2023 Jan-Dec.

    PubMed 36814898

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-321 in people with Advanced Solid Tumors Cancer, run by AbbVie at 18 sites in 3 countries.

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 16 inclusion and 14 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 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Australia, Israel. 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?

AUCt for ABBV-321 (time frame: Up to 78 days post dose). 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 NCT03234712, 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 6 May 2021.

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