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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

NCT05005403

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT05005403

Trial Eligibility

Document

Title

  • 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 Pembrolizumab or 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 Pembrolizumab or Budigalimab

Clinical Trial IDs

  • ORG STUDY ID: M21-410
  • SECONDARY ID: 2021-002715-65
  • NCT ID: NCT05005403

Conditions

  • Non-Small Cell Lung Cancer
  • Head and Neck Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
ABBV-514Part 1 Dose Escalation: ABBV-514
PembrolizumabKeytrudaPart 1 Dose Escalation: ABBV-514 + Pembrolizumab
BudigalimabABBV-181Part 2 Dose Expansion: ABBV-514 + Budigalimab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Part 1 Dose Escalation: ABBV-514ExperimentalParticipants will receive ABBV-514.
  • ABBV-514
Part 1 Dose Escalation: ABBV-514 + PembrolizumabExperimentalParticipants will receive ABBV-514 in combination with pembrolizumab.
  • ABBV-514
  • Pembrolizumab
Part 2 Dose Expansion: ABBV-514ExperimentalParticipants will receive ABBV-514 at recommended dose determined in Dose Escalation portion.
  • ABBV-514
Part 2 Dose Expansion: ABBV-514 + PembrolizumabExperimentalParticipants will receive ABBV-514 at recommended dose determined in Dose Escalation portion in combination with pembrolizumab
  • ABBV-514
  • Pembrolizumab
Part 2 Dose Expansion: ABBV-514 + BudigalimabExperimentalParticipants will receive ABBV-514 at recommended dose determined in Dose Escalation portion in combination with budigalimab.
  • ABBV-514
  • Budigalimab

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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Adverse Events (AE)
Time Frame:Up to 2 Years
Safety Issue:
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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Head and Neck Squamous Cell Carcinoma
  • HNSCC
  • Solid Tumors
  • Budigalimab
  • ABBV-181
  • ABBV-514
  • KEYTRUDA
  • Pembrolizumab

Last Updated

August 13, 2021