ABBV-303 + Budigalimab for Solid Tumors
Recruiting in Palo Alto (17 mi)
+19 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: AbbVie
Disqualifiers: Infections, Hypersensitivity, Low body weight, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a new drug, ABBV-303, alone or with another drug, budigalimab, to treat adults with certain types of cancer that have returned or resisted other treatments. The drugs are given through an IV and aim to target and destroy cancer cells, possibly boosting the immune system's response.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug ABBV-303 + Budigalimab for solid tumors?
Budigalimab, a part of the treatment, has shown some effectiveness in early trials for advanced solid tumors, with a few patients responding to the drug. Its safety profile is similar to other drugs that target PD-1, a protein that helps keep the immune system from attacking cancer cells.
12345What is known about the safety of Budigalimab (ABBV-181) in humans?
In a phase I trial, Budigalimab was tested in patients with advanced solid tumors, and immune-related side effects were reported in about 18.6% of patients, with only 1.7% experiencing severe side effects. The safety profile was similar to other drugs targeting the same PD-1 receptor, and no treatment-related deaths were reported.
13467What makes the drug ABBV-303 + Budigalimab unique for treating solid tumors?
The combination of ABBV-303 and Budigalimab is unique because Budigalimab is a monoclonal antibody that targets the PD-1 receptor, which plays a role in the immune system's ability to fight cancer. This drug is administered intravenously and has shown a consistent safety profile similar to other PD-1 targeting agents, with a dosing regimen informed by pharmacokinetic modeling to optimize its effectiveness.
46789Eligibility Criteria
This trial is for adults with advanced solid tumors that have not responded to previous treatments. Participants must be in good physical condition (ECOG status of 0 or 1), have certain laboratory values within normal ranges, and their tumor size can be measured by standard criteria.Inclusion Criteria
Laboratory values meeting the protocol's criteria within the screening period (-28 days) prior to the first dose of study drug
Your recent lab test results need to meet the study's requirements before you can take the study drug.
I am fully active or can carry out light work.
+5 more
Exclusion Criteria
My body weight is less than 35 kg.
I don't have lasting side effects from cancer treatment, except for hair loss.
I do not have any active infections needing antibiotics or antifungal treatment.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive ABBV-303 as monotherapy or in combination with budigalimab in escalating doses to determine the maximum tolerable dose or recommended phase 1 expansion dose
Up to 3 years
Regular visits at a hospital or clinic for medical assessments, blood tests, and scans
Follow-up
Participants are monitored for safety and effectiveness after treatment
4-8 weeks
Participant Groups
The study tests ABBV-303 alone and combined with Budigalimab in patients with relapsed/refractory solid tumors. It explores the safety, how the body processes these drugs, and their effect on cancer over a period of up to three years.
7Treatment groups
Experimental Treatment
Group I: ABBV-303 Dose Expansion: Part 5A MonotherapyExperimental Treatment1 Intervention
Tissue agnostic with R/R participants with MET amplification by any commercially available test will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.
Group II: ABBV-303 Dose Expansion: Part 4A MonotherapyExperimental Treatment1 Intervention
Participants with R/R HNSCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.
Group III: ABBV-303 Dose Expansion: Part 3A MonotherapyExperimental Treatment1 Intervention
Participants with R/R RCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.
Group IV: ABBV-303 Dose Expansion: Part 2B CombinationExperimental Treatment2 Interventions
Participants with R/R NSCLC will receive ABBV-303 at or below the MTD in combination with budigalimab as part of the 3 year study duration.
Group V: ABBV-303 Dose Expansion: Part 2A MonotherapyExperimental Treatment1 Intervention
Participants with R/R NSCLC will receive ABBV-303 at the recommended phase 1 expansion dose (RP1ED) as a monotherapy as part of the 3 year study duration.
Group VI: ABBV-303 Dose Escalation: Part 1B CombinationExperimental Treatment2 Interventions
Participants with R/R solid tumors will receive ABBV-303 in combination with budigalimab at or below the MTD as part of the 3 year study duration.
Group VII: ABBV-303 Dose Escalation: Part 1A MonotherapyExperimental Treatment1 Intervention
Participants with (R)/refractory (R) solid tumors will receive ABBV-303 in escalating doses as a monotherapy until the maximum tolerable dose (MTD) is determined as part of the 3 year study duration.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Carolina BioOncology Institute /ID# 254305Huntersville, NC
START Midwest /ID# 256945Grand Rapids, MI
NEXT Oncology /ID# 257395San Antonio, TX
University of Texas MD Anderson Cancer Center /ID# 254308Houston, TX
More Trial Locations
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Who Is Running the Clinical Trial?
AbbVieLead Sponsor
References
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.
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.
Safety and antitumour activity of cadonilimab, an anti-PD-1/CTLA-4 bispecific antibody, for patients with advanced solid tumours (COMPASSION-03): a multicentre, open-label, phase 1b/2 trial. [2023]Immune checkpoint inhibitors targeting PD-1 or CTLA-4 individually have shown substantial clinical benefits in the treatment of malignancies. We aimed to assess the safety and antitumour activity of cadonilimab monotherapy, a bispecific PD-1/CTLA-4 antibody, in patients with advanced solid tumours.
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.
Pembrolizumab May Substantially Up Cervical Cancer Survival. [2022]In the KEYNOTE-826 trial, the addition of the PD-1 inhibitor pembrolizumab to standard-of-care chemotherapy significantly prolonged progression-free survival and overall survival in patients with metastatic, recurrent, or persistent cervical cancer. These findings could define the new standard of care in these cases.
Avelumab Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With High-Expression Programmed Death-Ligand 1-Positive Metastatic NSCLC: Primary Analysis From the Phase 3 JAVELIN Lung 100 Trial. [2023]We report the primary analysis from JAVELIN Lung 100, a phase 3 trial comparing avelumab (anti-programmed death-ligand 1 [PD-L1]) versus platinum-based doublet chemotherapy as first-line treatment for PD-L1-positive (+) advanced NSCLC.
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).
A Randomized Phase II Study of MEDI0680 in Combination with Durvalumab versus Nivolumab Monotherapy in Patients with Advanced or Metastatic Clear-cell Renal Cell Carcinoma. [2023]MEDI0680 is a humanized anti-programmed cell death-1 (PD-1) antibody, and durvalumab is an anti-PD-L1 antibody. Combining treatment using these antibodies may improve efficacy versus blockade of PD-1 alone. This phase II study evaluated antitumor activity and safety of MEDI0680 plus durvalumab versus nivolumab monotherapy in immunotherapy-naïve patients with advanced clear-cell renal cell carcinoma who received at least one prior line of antiangiogenic therapy.
[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.