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ABBV-514 + Budigalimab for Lung & Head and Neck Cancers

Q: Are there vacancies available in this clinical experiment?

Affirmative. Clinicaltrials.gov attests that this medical research is still enrolling participants, with the initial post date of November 1st 2021 and latest update dated to July 11th 2022. 136 patients are required from 14 different sites for completion of the study.

Q: How many facilities are currently carrying out this trial?

There are 14 participating sites, such as Community Health Net (ID# 243011) in Indianapolis and Next <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> (ID#243007/243005) in Austin and Dallas respectively. Additionally, there are 11 other medical centres offering this clinical trial.

Q: Has ABBV-514 been officially authorized by the Food and Drug Administration?

The safety of ABBV-514 is determined to be a score of 1 due to limited clinical evidence supporting its efficacy and safety profile. Thus, this drug trial falls under the category of Phase 1 research.

Q: What is the aggregate population involved in this research project?

Affirmative. Clinicaltrials.gov affirms that this research is actively seeking patients; the study was first published on November 1st 2021 and updated most recently on July 11th 2022. In total, 136 individuals are sought from 14 various clinical sites across the nation.

Q: For what ailment is ABBV-514 commonly employed?

ABBV-514 is prescribed to treat malignant neoplasms, as well as advanced cases of <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, microsatellite instability high, and post-chemotherapy progression.

Q: Has the efficacy of ABBV-514 been investigated in any other research endeavors?

Currently, 966 clinical trials of ABBV-514 are operational with 122 in the advanced phase 3 stage. Although a majority of these experiments are located around Houston, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a>, there is an expansive network of medical centres running studies for ABBV-514 totaling 35890 sites.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial will assess the safety and efficacy of ABBV-514 as a monotherapy and in combination with Pembrolizumab or Budigalimab in participants with NSCLC and HNSCC.

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.Check my eligibility

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.See study design

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 below

Select...

My advanced cancer has not responded to or I cannot tolerate any known treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Antidrug Antibody (ADA)

Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-514

Maximum Observed Serum Concentration (Cmax) of ABBV-514

+4 more

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,169 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

146,883 Total Patients Enrolled

Media Library

ABBV-514 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05005403 — Phase 1

Non-Small Cell Lung Cancer Research Study Groups: Part 1 Dose Escalation: ABBV-514, Part 1 Dose Escalation: ABBV-514 + Budigalimab, Part 2 Dose Expansion: ABBV-514, Part 2 Dose Expansion: ABBV-514 + Budigalimab

Non-Small Cell Lung Cancer Clinical Trial 2023: ABBV-514 Highlights & Side Effects. Trial Name: NCT05005403 — Phase 1

ABBV-514 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05005403 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available in this clinical experiment?

"Affirmative. Clinicaltrials.gov attests that this medical research is still enrolling participants, with the initial post date of November 1st 2021 and latest update dated to July 11th 2022. 136 patients are required from 14 different sites for completion of the study."

Answered by AI

How many facilities are currently carrying out this trial?

"There are 14 participating sites, such as Community Health Net (ID# 243011) in Indianapolis and Next Oncology (ID#243007/243005) in Austin and Dallas respectively. Additionally, there are 11 other medical centres offering this clinical trial."

Answered by AI

Has ABBV-514 been officially authorized by the Food and Drug Administration?

"The safety of ABBV-514 is determined to be a score of 1 due to limited clinical evidence supporting its efficacy and safety profile. Thus, this drug trial falls under the category of Phase 1 research."

Answered by AI

What is the aggregate population involved in this research project?

"Affirmative. Clinicaltrials.gov affirms that this research is actively seeking patients; the study was first published on November 1st 2021 and updated most recently on July 11th 2022. In total, 136 individuals are sought from 14 various clinical sites across the nation."

Answered by AI

For what ailment is ABBV-514 commonly employed?

"ABBV-514 is prescribed to treat malignant neoplasms, as well as advanced cases of melanoma, microsatellite instability high, and post-chemotherapy progression."

Answered by AI

Has the efficacy of ABBV-514 been investigated in any other research endeavors?

"Currently, 966 clinical trials of ABBV-514 are operational with 122 in the advanced phase 3 stage. Although a majority of these experiments are located around Houston, Texas, there is an expansive network of medical centres running studies for ABBV-514 totaling 35890 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05005403.

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