Lung Cancer Clinical 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 Pembrolizumab or Budigalimab

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 Pembrolizumab or Budigalimab.

Budigalimab and ABBV-514 are investigational drugs being developed for the treatment of NSCLC, HNSCC, and other solid tumors. Pembrolizumab is a drug approved 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 Pembrolizumab or Budigalimab. Approximately 136 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 Pembrolizumab or 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.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

136

Study ID:

NCT05005403

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 14 Locations for this study

See Locations Near You

Providence Medical Foundation /ID# 247453
Fullerton California, 92835, United States
Miami Cancer Institute Baptist Health South Florida /ID# 232599
Miami Florida, 33176, United States
The University of Chicago Medical Center /ID# 248394
Chicago Illinois, 60637, United States
Fort Wayne Medical Oncology /ID# 232593
Fort Wayne Indiana, 46804, United States
Community Health Network, Inc. /ID# 243011
Indianapolis Indiana, 46250, United States
Onc/Hematology West PC dba Nebraska Cancer Specialists /ID# 247399
Omaha Nebraska, 68130, United States
Carolina BioOncology Institute /ID# 232597
Huntersville North Carolina, 28078, United States More Info
Site Coordinator
Contact
844-663-3742
NEXT Oncology Austin /ID# 243005
Austin Texas, 78705, United States
NEXT Oncology /ID# 243007
San Antonio Texas, 78229, United States
Virginia Cancer Specialists - Fairfax /ID# 232592
Fairfax Virginia, 22031, United States
The Chaim Sheba Medical Center /ID# 238332
Ramat Gan Tel-Aviv, 52656, Israel
Rambam Health Care Campus /ID# 238333
Haifa , 31096, Israel
National Cancer Center Hospital East /ID# 238840
Kashiwa-shi Chiba, 277-8, Japan
National Cancer Center Hospital /ID# 238372
Chuo-ku Tokyo, 104-0, Japan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

136

Study ID:

NCT05005403

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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