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Clinical Trials List

Protocol NumberM21-410
NCT Number(ClinicalTrials.gov Identfier)NCT05005403

2023-07-07 - 2025-12-31

Phase I

Recruiting5

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Global First-in-Human Study in NSCLC, HNSCC and Solid Tumors With ABBV-514 as a Single Agent and in Combination With Budigalimab

  • Trial Applicant

    AbbVie

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2024/05/28

Investigators and Locations

Principal Investigator Chia-Chi Lin 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 戴明燊 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

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

Objectives

main purpose ‧ Evaluate ABBV-514 as monotherapy and in combination with pembrolizumab or Safety, tolerability and pharmacokinetics (PK) of budigalimab when administered, and to determine determine its recommended phase 2 dose (RP2D) secondary purpose ‧ Evaluate ABBV-514 as monotherapy and in combination with pembrolizumab or Immunogenicity of budigalimab upon administration

Test Drug

ABBV-514ABBV-181 (Budigalimab)

Active Ingredient

ABBV-514
ABBV-181 (Budigalimab)

Dosage Form

Lyophilized Powder for Concentrate for Solution for Infusion
Lyophilized Powder for Concentrate for Solution for Infusion

Dosage

200
100

Endpoints

Safety test indicators
Safety assessment includes adverse event (AE) monitoring, physical examination, vital sign measurement, cardiac
Electrographic (ECG) variables and clinical laboratory tests (hematology, chemistry and urine routine tests
check).
pharmacokinetic index
ABBV-514 serum concentrations will be measured. PK parameter values ​​will be calculated including the maximum observed
Serum concentration (C max ), time to reach C max (T max ), terminal elimination half-life (t1/2) and blood
Area under the concentration-time curve (AUC). Serum samples will be collected to calculate drug resistance
Antibody (ADA)/neutralizing antidrug antibody (nADA) concentration.

Inclution 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 is not suitable for surgical resection and / or radiation therapy and 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

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.

The Estimated Number of Participants

  • Taiwan

    18 participants

  • Global

    136 participants

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