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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

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ClinicalTrials.gov Identifier: NCT05005403
Recruitment Status : Recruiting
First Posted : August 13, 2021
Last Update Posted : November 11, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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 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.


Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma Drug: ABBV-514 Drug: Pembrolizumab Drug: Budigalimab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Pembrolizumab or Budigalimab
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : May 4, 2026
Estimated Study Completion Date : May 4, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1 Dose Escalation: ABBV-514
Participants will receive ABBV-514.
 Drug: ABBV-514
Intravenous (IV) Infusion
Experimental: Part 1 Dose Escalation: ABBV-514 + Pembrolizumab
Participants will receive ABBV-514 in combination with pembrolizumab.
 Drug: ABBV-514
Intravenous (IV) Infusion

Drug: Pembrolizumab
IV Infusion
Other Name: Keytruda
Experimental: Part 2 Dose Expansion: ABBV-514
Participants will receive ABBV-514 at recommended dose determined in Dose Escalation portion.
 Drug: ABBV-514
Intravenous (IV) Infusion
Experimental: Part 2 Dose Expansion: ABBV-514 + Pembrolizumab
Participants will receive ABBV-514 at recommended dose determined in Dose Escalation portion in combination with pembrolizumab
 Drug: ABBV-514
Intravenous (IV) Infusion

Drug: Pembrolizumab
IV Infusion
Other Name: Keytruda
Experimental: Part 2 Dose Expansion: ABBV-514 + Budigalimab
Participants will receive ABBV-514 at recommended dose determined in Dose Escalation portion in combination with budigalimab.
 Drug: ABBV-514
Intravenous (IV) Infusion

Drug: Budigalimab
IV Infusion
Other Name: ABBV-181


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AE) [ Time Frame: Up to 2 Years ]
    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.

  2. Maximum Observed Serum Concentration (Cmax) of ABBV-514 [ Time Frame: Up to 2 Years ]
    Maximum Observed Serum Concentration (Cmax) of of ABBV-154.

  3. Time to Maximum Observed Serum Concentration (Tmax) of ABBV-514 [ Time Frame: Up to 2 Years ]
    Time to maximum Observed Serum Concentration (Tmax) of of ABBV-154.

  4. Terminal Elimination Half-Life (t1/2) of ABBV-514 [ Time Frame: Up to 2 Years ]
    Terminal elimination half-life (t1/2) of ABBV-514.

  5. Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-514 [ Time Frame: Up to 2 Years ]
    Area under the serum concentration versus time curve (AUC) of ABBV-514.

  6. Antidrug Antibody (ADA) [ Time Frame: Up to 2 Years ]
    Incidence and concentration of anti-drug antibodies.

  7. Neutralizing Antidrug Antibody (ADA) [ Time Frame: Up to 2 Years ]
    Incidence and concentration of neutralizing anti-drug antibodies.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05005403


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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United States, North Carolina
Carolina BioOncology Institute /ID# 232597 Not yet recruiting
Huntersville, North Carolina, United States, 28078
Israel
The Chaim Sheba Medical Center /ID# 238332 Not yet recruiting
Ramat Gan, Tel-Aviv, Israel, 5265601
Rambam Health Care Campus /ID# 238333 Not yet recruiting
Haifa, Israel, 3109601
Japan
National Cancer Center Hospital East /ID# 238840 Not yet recruiting
Kashiwa-shi, Chiba, Japan, 277-8577
National Cancer Center Hospital /ID# 238372 Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT05005403    
Other Study ID Numbers: M21-410
2021-002715-65 ( EudraCT Number )
First Posted: August 13, 2021    Key Record Dates
Last Update Posted: November 11, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by AbbVie:
Non-Small Cell Lung Cancer
NSCLC
Head and Neck Squamous Cell Carcinoma
HNSCC
Solid Tumors
 Budigalimab
ABBV-181
ABBV-514
KEYTRUDA
Pembrolizumab
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents