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Monoclonal Antibodies

Livmoniplimab + Budigalimab for Cancer

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
Participants with histologically or cytologically confirmed advanced or metastatic NSCLC who have received 1 prior line of chemotherapy and 1 prior anti-PD-(L)1 antibody, administered either concurrently or sequentially in the metastatic setting.
HNSCC (arising from the oral cavity, oropharynx, hypopharynx, or larynx) and must have progressed following treatment with platinum-based regimen (administered in any line of therapy) and a PD1/PDL1 antagonist administered in the recurrent or metastatic setting (progression following a PD1/PDL1 antagonist is defined as unequivocal progression on or within 3 months of the last dose of anti-PD1 or anti-PDL1 therapy).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days after the first dose of livmoniplimab monotherapy
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new drug, ABBV-151, either alone or in combination with another drug, budigalimab. The study will help to determine the best dose of ABBV-151 to use.

Who is the study for?
This trial is for adults with certain advanced solid tumors, including specific cancers of the bladder, urinary tract, pancreas, liver, and head/neck. Participants must have tried some treatments like platinum-based regimens or PD1/PDL1 antagonists without success. They should be in good physical condition (ECOG 0-1) and have proper organ function.Check my eligibility
What is being tested?
The study tests Livmoniplimab alone and combined with Budigalimab to find a safe dose level and check their effects on cancer. It has two parts: first finding the right doses (dose escalation), then giving those doses to more people to learn more about safety and effectiveness (dose expansion).See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea, immune-related conditions such as inflammation of organs or skin rashes. The severity can range from mild to serious but will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced NSCLC and have had one chemotherapy and one anti-PD-(L)1 treatment.
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My head or neck cancer worsened after platinum and PD1/PDL1 treatments.
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I am fully active or can carry out light work.
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My liver cancer has worsened despite one previous treatment.
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My colorectal cancer is stable and I've had 1-2 chemotherapy treatments.
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My bladder or urinary tract cancer worsened after platinum and PD1/PDL1 treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days after the first dose of livmoniplimab and budigalimab combination therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days after the first dose of livmoniplimab and budigalimab combination therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Escalation: RP2D Livmoniplimab + Budigalimab Combination Therapy
Dose Escalation: Recommended Phase 2 Dose (RP2D) Livmoniplimab Monotherapy
Dose Expansion: Objective Response Rate (ORR)
Secondary outcome measures
Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of Budigalimab
Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of Livmoniplimab
Change in Electrocardiogram (ECG)
+15 more

Trial Design

15Treatment groups
Experimental Treatment
Group I: Dose Expansion: Cohort 8 Livmoniplimab + BudigalimabExperimental Treatment2 Interventions
Participants with non-small cell lung cancer (NSCLC) [programmed death ligand 1 (PDL1) relapsed/refractory (R/R)] will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
Group II: Dose Expansion: Cohort 7 Livmoniplimab + BudigalimabExperimental Treatment2 Interventions
Participants with PD-1-naïve microsatellite stable colorectal cancer (MSS-CRC) [unselected] will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
Group III: Dose Expansion: Cohort 6 Livmoniplimab + BudigalimabExperimental Treatment2 Interventions
Participants with PD-1-ref head and neck squamous cell carcinoma (HNSCC) will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
Group IV: Dose Expansion: Cohort 5 Livmoniplimab + BudigalimabExperimental Treatment2 Interventions
Participants with PD-1-naïve hepatocellular carcinoma (HCC) will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
Group V: Dose Expansion: Cohort 4 Livmoniplimab + BudigalimabExperimental Treatment2 Interventions
Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
Group VI: Dose Expansion: Cohort 3 Livmoniplimab + BudigalimabExperimental Treatment2 Interventions
Participants with programmed cell death protein 1 (PD-1)-naïve pancreatic adenocarcinoma will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
Group VII: Dose Expansion: Cohort 12B Livmoniplimab + BudigalimabExperimental Treatment2 Interventions
Participants with PD-1-naïve ovarian granulosa (OG) cell tumors will receive livmoniplimab at the Dose C Q3W plus budigalimab Dose B administered Q3W.
Group VIII: Dose Expansion: Cohort 12A Livmoniplimab + BudigalimabExperimental Treatment2 Interventions
Participants with PD-1-naïve ovarian granulosa (OG) cell tumors will receive livmoniplimab at the Dose B Q3W plus budigalimab Dose B administered Q3W.
Group IX: Dose Expansion: Cohort 11C BudigalimabExperimental Treatment1 Intervention
Participants with PD-1-ref urothelial cancer will receive budigalimab Dose B administered Q3W.
Group X: Dose Expansion: Cohort 11B Livmoniplimab + BudigalimabExperimental Treatment2 Interventions
Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the Dose C Q3W plus budigalimab Dose B administered Q3W.
Group XI: Dose Expansion: Cohort 11A Livmoniplimab + BudigalimabExperimental Treatment2 Interventions
Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the Dose B Q3W plus budigalimab Dose B administered Q3W.
Group XII: Dose Expansion: Cohort 10B Livmoniplimab + BudigalimabExperimental Treatment2 Interventions
Participants with MSS-CRC (CMS4 enriched) will receive livmoniplimab at the dose C Q3W plus budigalimab Dose B administered Q3W.
Group XIII: Dose Expansion: Cohort 10A Livmoniplimab + BudigalimabExperimental Treatment2 Interventions
Participants with microsatellite stable colorectal cancer (MSS-CRC) [consensus molecular subtype 4 (CMS4) enriched] will receive livmoniplimab at the dose B Q3W plus budigalimab Dose B administered Q3W.
Group XIV: Dose Escalation: Cohort 2 Livmoniplimab + BudigalimabExperimental Treatment2 Interventions
Various doses of Livmoniplimab + Budigalimab administered during dose escalation to determine the Recommended Phase 2 Dose (RP2D).
Group XV: Dose Escalation: Cohort 1 LivmoniplimabExperimental Treatment1 Intervention
Various doses of Livmoniplimab administered during dose escalation to determine the Recommended Phase 2 Dose (RP2D).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budigalimab
2021
Completed Phase 1
~170

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,022 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,736 Total Patients Enrolled

Frequently Asked Questions

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

What is the population size of this research trial?

"To satisfy the predetermined inclusion criteria, 260 participants are needed to partake in this trial. These test subjects can join from AdventHealth Celebration /ID# 224860 in Kissimmee, Florida and Yale University /ID# 208356 near New Haven, Connecticut."

Answered by AI

Are there any prior investigations involving ABBV-151?

"ABBV-151 was initially trialled in 2018 at the Highlands Oncology Group, PA /ID# 207176 and has been followed by 5 completed studies. At present, 6 investigations are actively recruiting participants with many of them situated near Kissimmee, Florida."

Answered by AI

Is this clinical trial pioneering a new approach?

"Presently, 6 clinical studies are underway for the drug ABBV-151. These trials span 81 cities and 13 countries, with Phase 1 approval being first achieved in 2018 by AbbVie's sponsored trial that recruited 233 participants. Since then, 5 further trails have been conducted."

Answered by AI

Has the Food and Drug Administration sanctioned ABBV-151 for public use?

"ABBV-151's safety was only given a score of 1 due to the limited clinical evidence in regards to both effectiveness and security."

Answered by AI

What are the goals of this research endeavor?

"The purpose of this research is to understand the optimal dose and combination therapy for ABBV-151 over a 28 day period. Secondary objectives include measuring Maximum Observed Serum Concentration (Cmax) of ABBV-151, Dose Expansion: Progression-free Survival (PFS), and Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of ABBV-151."

Answered by AI

Are participants still being enrolled for this experimentation?

"Affirmative. According to clinicaltrials.gov, this experiment is in the process of recruiting volunteers; it was first posted on February 21st 2019 and has been recently updated as of September 26th 2022. 260 participants need to be recruited from 9 distinct medical sites."

Answered by AI

How many health care facilities are presently hosting this experiment?

"Nine medical facilities are currently recruiting for this project, such as AdventHealth Celebration (ID# 224860) in Kissimmee, Yale University (ID# 208356) in Celebration, and NYU Langone Medical Center (ID #209822) in New Haven. Additionally, there are 6 other locations involved."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors
2019. "Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03821935.
~138 spots leftby Jun 2027
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