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Small Cell Lung CancerPhase 1NCT03639194

A Study of ABBV-011 Alone and in Combination With Budigalimab (ABBV-181) in Participants With Relapsed or Refractory Small Cell Lung Cancer

A Phase 1 study testing ABBV-011 and Budigalimab in people with Small Cell Lung Cancer, run by AbbVie at 32 sites in 4 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a multicenter, open-label, Phase 1 study of ABBV-011 given as a single agent and in combination with budigalimab (ABBV-181) in participants with relapsed or refractory small cell lung cancer (SCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
ABBV-011 and Budigalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
32 sitesin 4 countries
Study dates
24 Oct 2018to 25 Jan 2024
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

  • Histologically or cytologically confirmed small cell lung cancer (SCLC) that is relapsed or refractory following at least 1 prior platinum-containing chemotherapy, but no more than 3 total prior lines of therapy, and with no curative therapy available.
  • Measurable disease, defined as at least 1 tumor lesion greater than or equal to 10 mm in the longest diameter or a lymph node greater than or equal to 15 mm in short axis measurement assessed by computed tomography (CT) scan, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Minimum life expectancy of at least 12 weeks.
  • Recovery to at least Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration.
  • Adequate hematologic, hepatic, neurologic, and renal function.
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  • All participants in Part B and Part C will be required to have tumor tissue that tests positive for target expression.
  • Sponsor may elect for confirmed SCLC tumor tissue to test positive for target expression for Parts A and D participants as well.
  • Last dose of any prior anticancer therapy >= 4 weeks before the first dose of study drug.
  • Additional Inclusion Criteria for Study Part B and Part C:
  • SCLC tumor tissue that tests positive for seizure-related homolog 6 (SEZ6) by immunohistochemistry (IHC).

Who cannot join

  • History of confirmed or suspected liver cirrhosis, hepatic veno-occlusive disease (VOD), sinusoidal obstruction syndrome (SOS), alcohol dependence, or ongoing excessive alcohol use.
  • Prior history of allogeneic or autologous stem cell transplantation.
  • Documented history of stroke or clinically significant cardiac disease as described in the protocol within 6 months prior to the first dose of study drug.
  • History of cardiac conduction abnormalities as described in the protocol.
  • Recent or ongoing serious infection, as described in the protocol.
  • Active SARS-CoV-2 infection.
Show all 23Show fewer
  • Prior or concomitant malignancies with some exceptions, as described in the protocol.
  • Any significant medical or psychiatric condition, including any suggested by Screening laboratory findings, that in the opinion of the Investigator or Sponsor may place the participant at undue risk from the study treatment, interfere with interpretation of study results, or compromise ability to comply with protocol requirements.
  • Participants with a history of hypersensitivity to the active ingredients or any excipients of study drugs (ABBV-011 or budigalimab [ABBV-181]) will be excluded.
  • Additional Exclusion Criteria for Part C:
  • History of inflammatory bowel disease.
  • Peripheral neuropathy Grade 2 with pain, or Grade 3 or higher.
  • Body weight less than 35 kilograms.
  • Active pneumonitis or interstitial lung disease (ILD) or a history of pneumonitis/ILD requiring treatment with steroids.
  • Participants previously treated with an anti PD-1/PD-L1 targeting agent must meet additional criteria described in the protocol.
  • Participant is judged by the Investigator to have evidence of ongoing hemolysis.
  • Immunosuppressive use with exceptions as per protocol.
  • Participants who have received a live vaccine within 30 days of start of study treatment.
  • Active autoimmune disease with exceptions as indicated in the protocol.
  • History of primary immunodeficiency, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
  • Participants with a history of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS).
  • Additional exclusion criteria for Japanese and Korean participants:
  • Participants with a history of interstitial lung disease (pneumonitis) or current interstitial lung disease (pneumonitis).

Trial locations and contacts

32 sites in 4 countries.

32 sites in 4 countries

United States21 sites

  • University of Michigan Comprehensive Cancer Center /ID# 207177

    Ann Arbor, Michigan, 48109-5000

  • University of Alabama at Birmingham - Main /ID# 207295

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital /ID# 207549

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute /ID# 213032

    Boston, Massachusetts, 02215

  • UH Cleveland Medical Center /ID# 207561

    Cleveland, Ohio, 44106

  • The Ohio State University /ID# 207552

    Columbus, Ohio, 43210

  • Henry Ford Hospital /ID# 233539

    Detroit, Michigan, 48202

  • Duke Cancer Center /ID# 207547

    Durham, North Carolina, 27710

  • University of Iowa Hospitals and Clinics /ID# 207560

    Iowa City, Iowa, 52242

  • University of Kentucky Chandler Medical Center /ID# 208217

    Lexington, Kentucky, 40536

  • Univ of Wisconsin Hosp/Clinics /ID# 207556

    Madison, Wisconsin, 53792-0001

  • Tennessee Oncology, PLLC /ID# 207175

    Nashville, Tennessee, 37203

  • Vanderbilt Ingram Cancer Center /ID# 207551

    Nashville, Tennessee, 37232-0021

  • Yale School of Medicine /ID# 207559

    New Haven, Connecticut, 06519

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 208216

    New York, New York, 10065-6007

  • University of California, Davis Comprehensive Cancer Center /ID# 207548

    Sacramento, California, 95817

  • University of Utah /ID# 207553

    Salt Lake City, Utah, 84112-5500

  • NEXT Oncology /ID# 207167

    San Antonio, Texas, 78229

  • University of Washington /ID# 207557

    Seattle, Washington, 98109

  • Highlands Oncology Group, PA /ID# 207176

    Springdale, Arkansas, 72762

  • Washington University-School of Medicine /ID# 207168

    St Louis, Missouri, 63110

Other trials in United States

Japan5 sites

  • National Cancer Center Hospital East /ID# 230943

    Kashiwa-shi, Chiba, 277-8577

  • National Hospital Organization Shikoku Cancer Center /ID# 229737

    Matsuyama, Ehime, 791-0280

  • Hokkaido Cancer Center /ID# 229101

    Sapporo, Hokkaido, 003-0804

  • Shizuoka Cancer Center /ID# 230911

    Sunto-gun, Shizuoka, 411-8777

  • Wakayama Medical University Hospital /ID# 229111

    Wakayama, Wakayama, 641-8510

Other trials in Japan

South Korea5 sites

  • National Cancer Center /ID# 240169

    Goyang, Gyeonggido, 10408

  • Seoul National University Bundang Hospital /ID# 234274

    Seongnam, Gyeonggido, 13620

  • Yonsei University Health System Severance Hospital /ID# 239515

    Seoul, Seoul Teugbyeolsi, 03722

  • Seoul National University Hospital /ID# 234272

    Seoul, 03080

  • Asan Medical Center /ID# 234273

    Seoul, 05505

Other trials in South Korea

Taiwan1 site

  • National Cheng Kung University Hospital /ID# 234267

    Tainan, 704

Other trials in Taiwan

About this study

Official title: A Phase I Study of ABBV-011 as a Single-Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Relapsed or Refractory Small Cell Lung Cancer

This is a multicenter, open-label, Phase 1 study of ABBV-011 given as a single agent and in combination with budigalimab (ABBV-181) in participants with relapsed or refractory small cell lung cancer (SCLC). The study consists of 4 parts: Part A is a single-agent ABBV-011 dose regimen finding cohort; followed by Part B, a single-agent ABBV-011 dose expansion cohort; and then Part C, an ABBV-011 and budigalimab (ABBV-181) combination escalation and expansion cohort; Part D, single-agent ABBV-011 dose-evaluating cohort for Japan.

Being tested
ABBV-011, Budigalimab
Keywords
Cancer, Small Cell Lung Cancer, Small Cell Lung Carcinoma
Medical subject headings
Small Cell Lung Carcinoma, Neoplasms

What participants receive

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

  • ABBV-011Drug

    Also called SC-011

    Intravenous

  • BudigalimabDrug

    Also called ABBV-181

    Intravenous

Study groups in NCT03639194
Study groupRoleWhat they receive
Part A: ABBV-011 Dose EscalationExperimentalABBV-011 via intravenous administration at various doses and dosing regimens until the maximum tolerated dose and/or the recommended Part B dose(s) is declared.
Receives: Drug: ABBV-011
Part B: ABBV-011 Dose ExpansionExperimentalABBV-011 via intravenous administration at dose regimen(s) that will not exceed the maximum tolerated dose determined in Part A.
Receives: Drug: ABBV-011
Part C: ABBV-011 + Budigalimab Escalation and ExpansionExperimentalABBV-011 via intravenous administration at various doses and dosing regimens starting at least 1 dose level below the recommended single-agent dose of ABBV-011 for Part B plus Budigalimab via intravenous administration at fixed doses and various dosing regimens.
Receives: Drug: ABBV-011; Drug: Budigalimab
Part D: ABBV-011 Dose Evaluation for JapanExperimentalABBV-011 via intravenous administration will be administered every 3 weeks (Q3wk), on Day 1 of each 21-day cycle or alternate dosing regimens.
Receives: Drug: ABBV-011

What is being measured

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

  1. Number of Participants With Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  2. Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011

    The Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 will be determined during the Part A dose escalation cohort.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  3. Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 in Combination with Budigalimab

    The Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 in combination with budigalimab will be determined during the Part C dose escalation cohort.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  4. Number of Participants With Dose Limiting Toxicities (DLTs)

    DLTs are adverse events as described in the protocol.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  5. Mean Change from Baseline in Vital Signs

    Mean change from Baseline in vital signs like blood pressure will be assessed.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  6. Incidence of Laboratory Abnormaities

    Number of participants with lab abnormalities will be assessed.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  7. Mean Change from Baseline in Electrocardiogram (ECG) Parameters

    Mean change from Baseline in ECG parameters like QTc interval will be assessed.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

Secondary outcomes (16)

  1. Maximum Serum Concentration (Cmax) of ABBV-011

    Maximum Serum Concentration (Cmax) of ABBV-011.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  2. Area Under the Serum Concentration-Time Curve (AUCinf) of ABBV-011

    Area under the serum concentration-time curve within a dosing interval of ABBV-011.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  3. Area Under the Serum Concentration-Time Curve within a Dosing Interval (AUC0-t) of ABBV-011

    Area under the serum concentration-time curve within a dosing interval (AUC0-t) of ABBV-011.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  4. Time to Maximum Serum Concentration (Tmax) of ABBV-011

    Time to maximum serum concentration (Tmax) of ABBV-011.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  5. Observed Serum Concentration at Trough (Ctrough) of ABBV-011

    Observed serum concentration at trough (Ctrough) of ABBV-011.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  6. Apparent Terminal Half-Life (T1/2) of ABBV-011

    Apparent terminal half-life (T1/2) of ABBV-011.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  7. Accumulation Ratio of ABBV-011

    Accumulation ratio of ABBV-011.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  8. Serum Clearance (CL) of ABBV-011

    Serum clearance of ABBV011.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  9. Steady State Volume of Distribution (Vss) of ABBV-011

    Steady state volume of distribution (Vss) of ABBV-011.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  10. Incidence of Antidrug Antibodies (ADA) Against ABBV-011 or Budigalimab (ABBV-181)

    Number of participants with incidence of ADAs against ABBV-011 or budigalimab will be assessed.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  11. Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    ORR is defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR).

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  12. Clinical Benefit Rate (CBR)

    CBR is defined as the percentage of participants with best overall response (confirmed or unconfirmed) of CR, PR or stable disease (SD).

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  13. Duration of Response (DOR)

    DOR is defined as the time from the participant's initial objective response (CR or PR) to Progressive Disease (PD) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  14. Duration of Clinical Benefit (DOCB)

    (DOCB) is defined as the time from the participant's initial observation of clinical benefit (CR or PR or SD) to PD or death due to any cause, whichever occurs first.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  15. Progression-Free Survival (PFS)

    PFS time is defined as the time from the subject's first dose of study drug (Day 1) to either the subject's disease progression (PD) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

  16. Overall Survival (OS)

    OS is defined as the time from the subject's first dose date to death due to any cause.

    Measured: Up to approximately 5 years after the first participant receives first dose of study drug

Timeline

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

  1. First posted21 Aug 2018
  2. Study start24 Oct 2018
  3. Primary completion25 Jan 2024
  4. Study completion25 Jan 2024

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
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03639194
Sponsor's protocol ID
M17-327
Status last verified
Feb 2024
First submitted
17 Aug 2018
Last updated
9 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wiedemeyer WR, Gavrilyuk J, Schammel A, Zhao X, Sarvaiya H, Pysz M, Gu C, You M, Isse K, Sullivan T, French D, Lee C, Dang AT, Zhang Z, Aujay M, Bankovich AJ, Vitorino P. ABBV-011, A Novel, Calicheamicin-Based Antibody-Drug Conjugate, Targets SEZ6 to Eradicate Small Cell Lung Cancer Tumors. Mol Cancer Ther. 2022 Jun 1;21(6):986-998. doi: 10.1158/1535-7163.MCT-21-0851.

    PubMed 35642431

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-011 and Budigalimab in people with Small Cell Lung Cancer, run by AbbVie at 32 sites in 4 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 11 inclusion and 23 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 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Japan, South Korea, Taiwan. 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?

Number of Participants With Adverse Events (time frame: Up to approximately 5 years after the first participant receives first dose of study drug). The study lists 7 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 NCT03639194, 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 9 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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