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ABBV-514 + Budigalimab for Lung & Head and Neck Cancers
Phase 1
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
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.
Must not have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two experimental drugs, ABBV-514 and Budigalimab, on adults with specific types of cancer. The goal is to find out if these drugs can help treat lung and head/neck cancers by monitoring their effects and side effects.
Who is the study for?
Adults with advanced or metastatic NSCLC or HNSCC that have relapsed after platinum-based chemotherapy and PD-1/PD-L1 therapy can join. They must have measurable disease, meet certain lab criteria, and be in good physical condition (ECOG ≤ 1). Those with specific genetic mutations (EGFR, ALK) in NSCLC are excluded.
What is being tested?
The trial is testing ABBV-514 alone or combined with Budigalimab on patients with NSCLC and HNSCC. It aims to find the highest dose patients can tolerate without severe side effects. Participants will receive IV infusions of these drugs for up to two years at hospitals or clinics worldwide.
What are the potential side effects?
Potential side effects include reactions related to the infusion process, changes in blood tests indicating organ function issues, fatigue, and other symptoms as a result of how the drugs affect cancer cells and healthy tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced cancer has not responded to or I cannot tolerate any known treatments.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My lung cancer has returned but does not have EGFR mutations or ALK rearrangements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Antidrug Antibody (ADA)
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-514
Maximum Observed Serum Concentration (Cmax) of ABBV-514
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Part 2 Dose Expansion: ABBV-514 + BudigalimabExperimental Treatment2 Interventions
Participants will receive ABBV-514 at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Group II: Part 2 Dose Expansion: ABBV-514Experimental Treatment1 Intervention
Participants will receive ABBV-514 at recommended dose determined in Dose Escalation portion.
Group III: Part 1 Dose Escalation: ABBV-514 + BudigalimabExperimental Treatment2 Interventions
Participants will receive ABBV-514 in combination with budigalimab.
Group IV: Part 1 Dose Escalation: ABBV-514Experimental Treatment1 Intervention
Participants will receive ABBV-514.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budigalimab
2021
Completed Phase 1
~170
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and immunotherapies. Targeted therapies, such as tyrosine kinase inhibitors (TKIs), work by blocking specific molecules and pathways that are essential for cancer cell growth and survival.
Immunotherapies, like PD-1/PD-L1 inhibitors, enhance the body's immune response against cancer cells by preventing the cancer from evading immune detection. These mechanisms are important for NSCLC patients as they allow for more personalized and effective treatment options, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.
Emerging therapeutic agents for lung cancer.Clinical trials of tyrosine kinase inhibitors for lung cancer in China: a review.A tabulated summary of targeted and biologic therapies for non-small-cell lung cancer.
Emerging therapeutic agents for lung cancer.Clinical trials of tyrosine kinase inhibitors for lung cancer in China: a review.A tabulated summary of targeted and biologic therapies for non-small-cell lung cancer.
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,019 Previous Clinical Trials
519,615 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
441 Previous Clinical Trials
160,064 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My advanced cancer has not responded to or I cannot tolerate any known treatments.My lung cancer has returned but does not have EGFR mutations or ALK rearrangements.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 Dose Escalation: ABBV-514
- Group 2: Part 1 Dose Escalation: ABBV-514 + Budigalimab
- Group 3: Part 2 Dose Expansion: ABBV-514
- Group 4: Part 2 Dose Expansion: ABBV-514 + Budigalimab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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