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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05005403

Collaborator

(none)

136

Enrollment

Locations

Arms

Anticipated Duration (Months)

9.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2021

Anticipated Primary Completion Date :

May 4, 2026

Anticipated Study Completion Date :

May 4, 2026

Arms and Interventions

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 Names: 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 Names: 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 Names: ABBV-181

Outcome Measures

Primary Outcome Measures

Number of Participants with Adverse Events (AE) [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.
Maximum Observed Serum Concentration (Cmax) of ABBV-514 [Up to 2 Years]
Maximum Observed Serum Concentration (Cmax) of of ABBV-154.
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-514 [Up to 2 Years]
Time to maximum Observed Serum Concentration (Tmax) of of ABBV-154.
Terminal Elimination Half-Life (t1/2) of ABBV-514 [Up to 2 Years]
Terminal elimination half-life (t1/2) of ABBV-514.
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-514 [Up to 2 Years]
Area under the serum concentration versus time curve (AUC) of ABBV-514.
Antidrug Antibody (ADA) [Up to 2 Years]
Incidence and concentration of anti-drug antibodies.
Neutralizing Antidrug Antibody (ADA) [Up to 2 Years]
Incidence and concentration of neutralizing anti-drug antibodies.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Providence Medical Foundation /ID# 247453	Fullerton	California	United States	92835
2	Miami Cancer Institute Baptist Health South Florida /ID# 232599	Miami	Florida	United States	33176
3	The University of Chicago Medical Center /ID# 248394	Chicago	Illinois	United States	60637-1443
4	Fort Wayne Medical Oncology /ID# 232593	Fort Wayne	Indiana	United States	46804
5	Community Health Network, Inc. /ID# 243011	Indianapolis	Indiana	United States	46250-2042
6	Onc/Hematology West PC dba Nebraska Cancer Specialists /ID# 247399	Omaha	Nebraska	United States	68130
7	Carolina BioOncology Institute /ID# 232597	Huntersville	North Carolina	United States	28078
8	NEXT Oncology Austin /ID# 243005	Austin	Texas	United States	78705-1171
9	NEXT Oncology /ID# 243007	San Antonio	Texas	United States	78229
10	Virginia Cancer Specialists - Fairfax /ID# 232592	Fairfax	Virginia	United States	22031
11	The Chaim Sheba Medical Center /ID# 238332	Ramat Gan	Tel-Aviv	Israel	5265601
12	Rambam Health Care Campus /ID# 238333	Haifa		Israel	3109601
13	National Cancer Center Hospital East /ID# 238840	Kashiwa-shi	Chiba	Japan	277-8577
14	National Cancer Center Hospital /ID# 238372	Chuo-ku	Tokyo	Japan	104-0045