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

Non-Small Cell Lung Cancer Clinical Trial

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 Budigalimab

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05005403
• Other study ID #: M21-410
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2021
• Est. completion date: May 4, 2026

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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 268 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: May 4, 2026
• Est. primary completion date: May 4, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• ABBV-514
Intravenous (IV) Infusion
• Budigalimab
IV Infusion

Locations

Country	Name	City	State
Israel	Rabin Medical Center /ID# 250497	Haifa
Israel	Rambam Health Care Campus /ID# 238333	Haifa	H_efa
Israel	Hadassah Medical Center-Hebrew University /ID# 252287	Jerusalem
Israel	The Chaim Sheba Medical Center /ID# 238332	Ramat Gan	Tel-Aviv
Japan	National Cancer Center Hospital /ID# 238372	Chuo-ku	Tokyo
Japan	National Cancer Center Hospital East /ID# 238840	Kashiwa-shi	Chiba
Japan	Kobe University Hospital /ID# 250409	Kobe	Hyogo
Japan	Aichi Cancer Center Hospital /ID# 250405	Nagoya-shi	Aichi
Japan	Shizuoka Cancer Center /ID# 250408	Sunto-gun	Shizuoka
Korea, Republic of	National Cancer Center /ID# 252290	Goyang-si	Gyeonggido
Korea, Republic of	CHA Bundang Medical Center /ID# 252291	Seongnam	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 252289	Seoul	Seoul Teugbyeolsi
Korea, Republic of	The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 252288	Seoul
United States	NEXT Oncology Austin /ID# 243005	Austin	Texas
United States	University of Illinois at Chicago /ID# 251750	Chicago	Illinois
United States	Virginia Cancer Specialists - Fairfax /ID# 232592	Fairfax	Virginia
United States	Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593	Fort Wayne	Indiana
United States	Carolina BioOncology Institute /ID# 232597	Huntersville	North Carolina
United States	Community Health Network, Inc. /ID# 243011	Indianapolis	Indiana
United States	Norton Cancer Institute /ID# 248903	Louisville	Kentucky
United States	Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399	Omaha	Nebraska
United States	NEXT Oncology /ID# 243007	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Israel,  Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum Observed Serum Concentration (Cmax) of ABBV-514	Maximum Observed Serum Concentration (Cmax) of of ABBV-514.	Up to 2 Years
Primary	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
Primary	Terminal Elimination Half-Life (t1/2) of ABBV-514	Terminal elimination half-life (t1/2) of ABBV-514.	Up to 2 Years
Primary	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
Primary	Antidrug Antibody (ADA)	Incidence and concentration of anti-drug antibodies.	Up to 2 Years
Primary	Neutralizing Antidrug Antibody (nADA)	Incidence and concentration of neutralizing anti-drug antibodies.	Up to 2 Years