Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: AbbVie
Must not be taking: Immunosuppressants
Disqualifiers: Immunodeficiency, Transplantation, CNS metastases, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing two experimental drugs, livmoniplimab and budigalimab, to see if they can help patients who need new treatment options by boosting their immune systems. Budigalimab is an experimental drug being tested for its effectiveness.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot have received any anticancer therapy, including chemotherapy or immunotherapy, within a certain period before starting the study drug. Also, you should not use immunosuppressive medication within 14 days before the first dose.
What data supports the effectiveness of the drug Livmoniplimab + Budigalimab for cancer?
Research shows that budigalimab, a component of the treatment, has been studied in patients with certain types of cancer like non-small cell lung cancer and head and neck cancer, demonstrating safety and some effectiveness. Additionally, similar drugs that target PD-1, like cadonilimab, have been approved for treating other cancers, suggesting potential effectiveness.
12345Is the combination of Livmoniplimab and Budigalimab generally safe for humans?
Budigalimab, one of the components of the treatment, has been tested in early clinical trials and showed a safety profile consistent with other similar treatments, with some patients experiencing immune-related side effects. No severe treatment-related deaths were reported, indicating it is generally safe, but monitoring for side effects is important.
36789What makes the drug Livmoniplimab + Budigalimab unique for cancer treatment?
Livmoniplimab + Budigalimab is unique because it combines two monoclonal antibodies, one targeting PD-1 (a protein that helps cancer cells evade the immune system) and the other potentially targeting a different immune checkpoint, offering a novel approach to enhance the body's immune response against cancer.
235810Eligibility Criteria
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.Inclusion Criteria
My pancreatic cancer worsened after at least one treatment.
I have advanced NSCLC and have had one chemotherapy and one anti-PD-(L)1 treatment.
My blood, kidney, liver, and clotting tests are normal.
+8 more
Exclusion Criteria
I haven't had any cancer treatment in the last 28 days or within 5 half-lives of the treatment, whichever is shorter.
I have had a primary immunodeficiency, bone marrow or organ transplant, or tuberculosis.
I have been treated with immunotherapies before, except if I have urothelial cancer or head and neck cancer.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation
Various doses of Livmoniplimab and Budigalimab are administered to determine the Recommended Phase 2 Dose (RP2D)
Up to 28 days
Dose Expansion
Participants receive Livmoniplimab and Budigalimab at the RP2D to assess safety, tolerability, and preliminary efficacy
Up to 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 9 months
Participant Groups
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).
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).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington University-School of Medicine /ID# 259684Saint Louis, MO
Community Health Network, Inc. /ID# 257032Indianapolis, IN
AdventHealth Celebration /ID# 224860Kissimmee, FL
NEXT Oncology /ID# 208930San Antonio, TX
More Trial Locations
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Who Is Running the Clinical Trial?
AbbVieLead Sponsor
References
Nivolumab Plus Erlotinib in Patients With EGFR-Mutant Advanced NSCLC. [2019]This phase I study evaluated nivolumab combined with erlotinib in patients with advanced EGFR-mutant NSCLC.
An Anti-TIGIT Antibody with a PD-1 Inhibitor Shows Promise in Solid Tumors. [2022]Combination of vibostolimab and pembrolizumab is well tolerated and has antitumor activity.
First-in-human phase 1 study of budigalimab, an anti-PD-1 inhibitor, in patients with non-small cell lung cancer and head and neck squamous cell carcinoma. [2023]Budigalimab is a humanized, recombinant immunoglobulin G1 monoclonal antibody targeting programmed cell death protein 1 (PD-1). We present the safety, efficacy, pharmacokinetic (PK), and pharmacodynamic data from patients enrolled in the head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) expansion cohorts of the phase 1 first-in-human study of budigalimab monotherapy (NCT03000257; registered 15 December 2016).
Cadonilimab: First Approval. [2022]Cadonilimab (®), a PD-1/CTLA-4 bi-specific antibody, is being developed by Akeso, Inc. for the treatment of a range of solid tumours, including cervical cancer, lung cancer, gastric/gastroesophageal junction cancer, oesophageal squamous cell cancer, liver cancer and nasopharyngeal cancer. Cadonilimab was approved in China in June 2022 for use in patients with relapsed or metastatic cervical cancer (r/mCC) who have progressed on or after platinum-based chemotherapy. This article summarizes the milestones in the development of cadonilimab leading to this first approval for the treatment of patients with r/mCC.
COM701 Shows Antitumor Activity, +/- Nivolumab. [2021]According to results from an ongoing phase I trial, the novel immune checkpoint inhibitor COM701, which targets PVRIG, has shown early signs of efficacy, on its own and combined with nivolumab, in patients with a variety of advanced solid tumors.
Linear IgA Disease of the Gingiva Following Nivolumab Therapy. [2020]Immunotherapy has advanced the treatment of solid organ malignancies. Although generally well tolerated, treatment with immune checkpoint inhibitors can be complicated by immune-related adverse events, some of which are relatively uncommon. We report the first case of gingival linear immunoglobulin A disease related to treatment with an antiprogrammed cell death protein 1 antibody. A 73-year-old male with advanced non-small cell lung cancer achieved a durable response to nivolumab monotherapy. After 1 year of treatment, he developed gingival swelling and pain. Biopsy revealed linear immunoglobulin A disease of the gingiva which was effectively treated with systemic steroids. Ongoing vigilance for immune-mediated toxicity is paramount during and after treatment with immune checkpoint inhibitors.
Rheumatic immune-and nonimmune-related adverse events in phase 3 clinical trials assessing PD-(L)1 checkpoint inhibitors for lung cancer: A systematic review and meta-analysis. [2022]We aimed to analyze rheumatic immune-related (ir) and nonimmune-related adverse events (AEs) due to immune-checkpoint inhibitors (ICIs) targeting programmed cell death-1 or its ligand PD-(L)1 in lung cancer patients from the available literature.
Model Informed Dosing Regimen and Phase I Results of the Anti-PD-1 Antibody Budigalimab (ABBV-181). [2021]Budigalimab is a humanized, recombinant, Fc mutated IgG1 monoclonal antibody targeting programmed cell death 1 (PD-1) receptor, currently in phase I clinical trials. The safety, efficacy, pharmacokinetics (PKs), pharmacodynamics (PDs), and budigalimab dose selection from monotherapy dose escalation and multihistology expansion cohorts were evaluated in patients with previously treated advanced solid tumors who received budigalimab at 1, 3, or 10 mg/kg intravenously every 2 weeks (Q2W) in dose escalation, including Japanese patients that received 3 and 10 mg/kg Q2W. PK modeling and PK/PD assessments informed the dosing regimen in expansion phase using data from body-weight-based dosing in the escalation phase, based on which patients in the multihistology expansion cohort received flat doses of 250 mg Q2W or 500 mg every four weeks (Q4W). Immune-related adverse events (AEs) were reported in 11 of 59 patients (18.6%), of which 1 of 59 (1.7%) was considered grade ≥ 3 and the safety profile of budigalimab was consistent with other PD-1 targeting agents. No treatment-related grade 5 AEs were reported. Four responses per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 were reported in the dose escalation cohort and none in the multihistology expansion cohort. PK of budigalimab was approximately dose proportional and sustained > 99% peripheral PD-1 receptor saturation was observed by 2 hours postdosing, across doses. PK/PD and safety profiles were comparable between Japanese and Western patients, and exposure-safety analyses did not indicate any trends. Observed PK and PD-1 receptor saturation were consistent with model predictions for flat doses and less frequent regimens, validating the early application of PK modeling and PK/PD assessments to inform the recommended dose and regimen, following dose escalation.
Hepatitis B Virus Reactivation in Cancer Patients Treated With Immune Checkpoint Inhibitors. [2023]There have been unique adverse events reported with targeted blockade of programmed death-1 (PD-1), programmed death-ligand-1 (PD-L1), and cytotoxic T-lymphocyte-associated protein-4 (CTLA4), including immune mediated toxicities. Recently, there have been reports of hepatitis B reactivation (HBVr) occurring with PD-1/PD-L1 inhibitors, which may result in treatment delays, interruptions, or discontinuation. This retrospective literature review and analysis of the Food and Drug Administration's (FDA) Adverse Events Reporting System (FAERS) queried reported cases of "Hepatitis B reactivation" reported with the PD-1/PD-L1 inhibitors "Pembrolizumab," "Atezolizumab," "Nivolumab," "Durvalumab," "Avelumab," and "Ipilimumab" from initial FDA approval to June 30, 2020. Disproportionality signal analysis was determined by calculating a reporting odds ratio (ROR) and 95% confidence intervals (CI). The ROR was considered significant when the lower and upper limits of the 95% CI were >1 and confirmed by the Fisher exact test (P
[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer]. [2017]Pembrolizumab, a humanized monoclonal antibody IgG4 anti-PD-1, having offered promising results in patients suffering from non-small cell lung cancer metastatic and heavily pretreated.