Back to resultsStudy to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of ABBV-514 Alone or in Combination With Budigalimab
Primary Purpose
Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABBV-514
Budigalimab
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer, NSCLC, Head and Neck Squamous Cell Carcinoma, HNSCC, Solid Tumors, Budigalimab, ABBV-181, ABBV-514
Eligibility Criteria
Inclusion Criteria:
Dose-escalation cohorts only:
-- Must have an advanced solid tumor who are considered refractory to or intolerant of all existing therapies known to provide a clinical benefit for their condition.
Relapsed Non-Small Cell Lung Cancer (NSCLC) Head and Neck Squamous Cell Carcinoma (HNSCC) dose-expansion cohorts only:
- Must have histologically or cytologically confirmed advanced or metastatic NSCLC or HNSCC that has been treated with platinum-based chemotherapy and a programmed cell death (PD)-1 or PD ligand 1 (PD-L1) targeting agent (separately or in combination therapy).
- Must have failed (or refused) treatment with available therapies known to be active for treatment of their disease.
- Participants enrolled in dose escalation must have disease that is evaluable or measurable per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1).
- Participants enrolled in dose expansion must have measurable disease per RECIST, version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
- Laboratory values meeting the criteria outlined in the protocol.
Exclusion Criteria:
- Relapsed Non-Small Cell Lung Cancer (NSCLC) Head and Neck Squamous Cell Carcinoma (HNSCC) dose-expansion cohorts only:
-- Non-Small Cell Lung Cancer (NSCLC) participants with known EGFR mutations or ALK gene rearrangements are ineligible.
Sites / Locations
- Providence Medical Foundation /ID# 247453
- Fort Wayne Medical Oncology /ID# 232593Recruiting
- Community Health Network, Inc. /ID# 243011Recruiting
- Onc/Hematology West PC dba Nebraska Cancer Specialists /ID# 247399Recruiting
- Carolina BioOncology Institute /ID# 232597Recruiting
- NEXT Oncology Austin /ID# 243005Recruiting
- NEXT Oncology /ID# 243007Recruiting
- Virginia Cancer Specialists - Fairfax /ID# 232592Recruiting
- The Chaim Sheba Medical Center /ID# 238332Recruiting
- Rambam Health Care Campus /ID# 238333Recruiting
- Aichi Cancer Center Hospital /ID# 250405Recruiting
- National Cancer Center Hospital East /ID# 238840Recruiting
- Kobe University Hospital /ID# 250409Recruiting
- Shizuoka Cancer Center /ID# 250408Recruiting
- National Cancer Center Hospital /ID# 238372Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Part 1 Dose Escalation: ABBV-514
Part 1 Dose Escalation: ABBV-514 + Budigalimab
Part 2 Dose Expansion: ABBV-514
Part 2 Dose Expansion: ABBV-514 + Budigalimab
Arm Description
Participants will receive ABBV-514.
Participants will receive ABBV-514 in combination with budigalimab.
Participants will receive ABBV-514 at recommended dose determined in Dose Escalation portion.
Participants will receive ABBV-514 at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events (AE)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Maximum Observed Serum Concentration (Cmax) of ABBV-514
Maximum Observed Serum Concentration (Cmax) of of ABBV-154.
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-514
Time to maximum Observed Serum Concentration (Tmax) of of ABBV-154.
Terminal Elimination Half-Life (t1/2) of ABBV-514
Terminal elimination half-life (t1/2) of ABBV-514.
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-514
Area under the serum concentration versus time curve (AUC) of ABBV-514.
Antidrug Antibody (ADA)
Incidence and concentration of anti-drug antibodies.
Neutralizing Antidrug Antibody (nADA)
Incidence and concentration of neutralizing anti-drug antibodies.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05005403
Brief Title
Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of ABBV-514 Alone or in Combination With Budigalimab
Official Title
A Global First-in-Human Study in NSCLC, HNSCC and Solid Tumors With ABBV-514 as a Single Agent and in Combination With Budigalimab
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
May 4, 2026 (Anticipated)
Study Completion Date
May 4, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. Head and Neck Squamous Cell Carcinoma (HNSCC) is a solid tumor, a disease in which cancer cells form in the tissues of the head and neck. The purpose of this study is to assess adverse events and pharmacokinetics of ABBV-514 as a monotherapy and in combination with Budigalimab.
Budigalimab and ABBV-514 are investigational drugs being developed for the treatment of NSCLC, HNSCC, and other solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) of ABBV-514 will be explored. Each treatment arm receives a different doses of ABBV-514 in monotherapy and in combination with Budigalimab. Approximately 176 adult participants will be enrolled in the study across approximately 80 sites worldwide.
Participants will receive ABBV-514 as a monotherapy or in combination with Budigalimab as an Intravenous (IV) Infusion for an estimated treatment period of up to 2 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Keywords
Non-Small Cell Lung Cancer, NSCLC, Head and Neck Squamous Cell Carcinoma, HNSCC, Solid Tumors, Budigalimab, ABBV-181, ABBV-514
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
176 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Part 1 Dose Escalation: ABBV-514
Arm Type
Experimental
Arm Description
Participants will receive ABBV-514.
Arm Title
Part 1 Dose Escalation: ABBV-514 + Budigalimab
Arm Type
Experimental
Arm Description
Participants will receive ABBV-514 in combination with budigalimab.
Arm Title
Part 2 Dose Expansion: ABBV-514
Arm Type
Experimental
Arm Description
Participants will receive ABBV-514 at recommended dose determined in Dose Escalation portion.
Arm Title
Part 2 Dose Expansion: ABBV-514 + Budigalimab
Arm Type
Experimental
Arm Description
Participants will receive ABBV-514 at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Intervention Type
Drug
Intervention Name(s)
ABBV-514
Intervention Description
Intravenous (IV) Infusion
Intervention Type
Drug
Intervention Name(s)
Budigalimab
Other Intervention Name(s)
ABBV-181
Intervention Description
IV Infusion
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AE)
Description
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time Frame
Up to 2 Years
Title
Maximum Observed Serum Concentration (Cmax) of ABBV-514
Description
Maximum Observed Serum Concentration (Cmax) of of ABBV-154.
Time Frame
Up to 2 Years
Title
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-514
Description
Time to maximum Observed Serum Concentration (Tmax) of of ABBV-154.
Time Frame
Up to 2 Years
Title
Terminal Elimination Half-Life (t1/2) of ABBV-514
Description
Terminal elimination half-life (t1/2) of ABBV-514.
Time Frame
Up to 2 Years
Title
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-514
Description
Area under the serum concentration versus time curve (AUC) of ABBV-514.
Time Frame
Up to 2 Years
Title
Antidrug Antibody (ADA)
Description
Incidence and concentration of anti-drug antibodies.
Time Frame
Up to 2 Years
Title
Neutralizing Antidrug Antibody (nADA)
Description
Incidence and concentration of neutralizing anti-drug antibodies.
Time Frame
Up to 2 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Dose-escalation cohorts only:
-- Must have an advanced solid tumor who are considered refractory to or intolerant of all existing therapies known to provide a clinical benefit for their condition.
Relapsed Non-Small Cell Lung Cancer (NSCLC) Head and Neck Squamous Cell Carcinoma (HNSCC) dose-expansion cohorts only:
Must have histologically or cytologically confirmed advanced or metastatic NSCLC or HNSCC that has been treated with platinum-based chemotherapy and a programmed cell death (PD)-1 or PD ligand 1 (PD-L1) targeting agent (separately or in combination therapy).
Must have failed (or refused) treatment with available therapies known to be active for treatment of their disease.
Participants enrolled in dose escalation must have disease that is evaluable or measurable per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1).
Participants enrolled in dose expansion must have measurable disease per RECIST, version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
Laboratory values meeting the criteria outlined in the protocol.
Exclusion Criteria:
- Relapsed Non-Small Cell Lung Cancer (NSCLC) Head and Neck Squamous Cell Carcinoma (HNSCC) dose-expansion cohorts only:
-- Non-Small Cell Lung Cancer (NSCLC) participants with known EGFR mutations or ALK gene rearrangements are ineligible.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Providence Medical Foundation /ID# 247453
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Fort Wayne Medical Oncology /ID# 232593
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Name
Community Health Network, Inc. /ID# 243011
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250-2042
Country
United States
Individual Site Status
Recruiting
Facility Name
Onc/Hematology West PC dba Nebraska Cancer Specialists /ID# 247399
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina BioOncology Institute /ID# 232597
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Individual Site Status
Recruiting
Facility Name
NEXT Oncology Austin /ID# 243005
City
Austin
State/Province
Texas
ZIP/Postal Code
78705-1171
Country
United States
Individual Site Status
Recruiting
Facility Name
NEXT Oncology /ID# 243007
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Cancer Specialists - Fairfax /ID# 232592
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
The Chaim Sheba Medical Center /ID# 238332
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus /ID# 238333
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Aichi Cancer Center Hospital /ID# 250405
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East /ID# 238840
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe University Hospital /ID# 250409
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shizuoka Cancer Center /ID# 250408
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital /ID# 238372
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of ABBV-514 Alone or in Combination With Budigalimab
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