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

Study Overview
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Brief Summary
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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 maximum-tolerated dose (MTD)/maximum administered dose (MAD) of ABBV-514 will be explored. Each treatment arm receives a different dose of ABBV-514 in monotherapy and in combination with Budigalimab. Approximately 215 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.

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

Conditions
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Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: ABBV-514
* Drug: Budigalimab


Participation Criteria
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Eligibility Criteria
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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: - 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1 Dose Escalation: ABBV-514<br>Participants will receive ABBV-514. | Drug: ABBV-514<br>* Intravenous (IV) Infusion<br>|
| Experimental: Part 1 Dose Escalation: ABBV-514 + Budigalimab<br>Participants will receive ABBV-514 in combination with budigalimab. | Drug: ABBV-514<br>* Intravenous (IV) Infusion<br>Drug: Budigalimab<br>* IV Infusion<br>* Other names: ABBV-181;|
| Experimental: Part 2 Dose Expansion: ABBV-514<br>Participants will receive ABBV-514 at recommended dose determined in Dose Escalation portion. | Drug: ABBV-514<br>* Intravenous (IV) Infusion<br>|
| Experimental: Part 2 Dose Expansion: ABBV-514 + Budigalimab<br>Participants will receive ABBV-514 at recommended dose determined in Dose Escalation portion in combination with budigalimab. | Drug: ABBV-514<br>* Intravenous (IV) Infusion<br>Drug: Budigalimab<br>* IV Infusion<br>* Other names: ABBV-181;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 2 Years | 
| Maximum Observed Serum Concentration (Cmax) of ABBV-514 | Maximum Observed Serum Concentration (Cmax) of of ABBV-514. | Up to 2 Years | 
| Time to Maximum Observed Serum Concentration (Tmax) of ABBV-514 | Time to maximum Observed Serum Concentration (Tmax) of of ABBV-514. | Up to 2 Years | 
| Terminal Elimination Half-Life (t1/2) of ABBV-514 | Terminal elimination half-life (t1/2) of ABBV-514. | Up to 2 Years | 
| Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-514 | Area under the serum concentration versus time curve (AUC) of ABBV-514. | Up to 2 Years | 
| Antidrug Antibody (ADA) | Incidence and concentration of anti-drug antibodies. | Up to 2 Years | 
| Neutralizing Antidrug Antibody (nADA) | Incidence and concentration of neutralizing anti-drug antibodies. | Up to 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Small Cell Lung Cancer, NSCLC, Head and Neck Squamous Cell Carcinoma, HNSCC, Solid Tumors, Budigalimab, ABBV-181, ABBV-514