Early phase clinical trials play an important role in evaluating new medications or a combination of medications for the first time in people. Researchers observe how a medication interacts with the human body, adjusting dosage and monitoring side effects.
The information gathered in early phase studies about a medication’s safety in relation to dosage, as well as signs of effectiveness, help determine its progression to a phase II study.
The Earle A. Chiles Research Institute, a division of Providence Cancer Institute of Oregon, has a robust early phase clinical trials portfolio that includes immunotherapies, targeted therapies and other novel agents under investigation. Some of these studies evaluate the safety and tolerability of a therapy through dose escalation, a progressive increase in the strength of the medication or therapy.
Dose escalation study of IO-108 and IO-108+pembrolizumab in patients with solid tumors
This phase I trial is currently recruiting patients with advanced solid tumors of any type that have relapsed or are unresponsive to treatment for a dose-escalation study of IO-108 as a monotherapy and in combination with pembrolizumab, an immunotherapy.
The goal of this two-arm study is to evaluate the maximum tolerated dose (MTD) or maximum administered dose (MAD), which will determine the recommended dose for a phase II trial. Additionally, the study will evaluate the safety, tolerability, effects on the body and clinical activity of IO-108 alone and with pembrolizumab.
IO-108 targets the LILRB2 (also known as ILT4), a protein that interacts with tumor microenvironment relevant ligands, suppressing an immune response. Preclinical data has shown that IO-108, a fully human IgG4 monoclonal antibody, blocks the interaction of LILRB2 with these ligands, which helps promote an immune response. Pembrolizumab may compliment this action by stimulating the immune system to help fight cancer.
Providence is one of only four locations worldwide recruiting patients for this trial. Matthew Taylor, M.D., medical director, Providence Thyroid Cancer Program, co-medical director, Providence Melanoma Program, is principal investigator of the study. Dr. Taylor also leads the Developmental Cancer Therapeutics Laboratory at the Earle A. Chiles Research Institute.
Find out more about this study here:
Providence’s ability to perform genomic sequencing make it possible to study sapanisertib in patients with two types of lung cancer
This phase II trial is currently recruiting patients with stage IV NFE2L2-mutated or wild-type squamous non-small cell lung cancer (sqNSCLC) whose disease has progressed while taking or after receiving at least two prior systemic therapies, including platinum-based chemotherapy and an immune checkpoint inhibitor. NFE2L2 is a gene that encodes the protein NRF2, and wild type refers to the non-mutated version of the disease.
To participate in the trial, patients must have the NFE2L2 mutation status identified using next generation sequencing (genomic sequencing) on archival or fresh tissue or circulating tumor DNA, which may be found in a blood sample. The genomic sequencing must be completed in a College of American Pathologists (CAP)-accredited and/or a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
Providence Genomics offers the largest molecular genomics sequencing facility on the West Coast. Through the Portland-based Providence Molecular Genomics Laboratory, a CLIA-certified laboratory, patients and providers have access to genomic sequencing technology and resources. These capabilities make it possible for Providence to conduct highly personalized clinical studies for specific genetic mutations, such as NFE2L2, that may serve as therapeutic targets.
Researchers will evaluate sapanisertib, a targeted therapy, in a study that includes 30 patients with NFE2L2 mutations in their cancer and 20 patients whose cancer does not have the NFE2L2 mutation. Each group will be randomized 1:1 to one of two doses of sapanisertib and schedules for administering the medication.
In October 2022, the Food and Drug Administration granted a fast-track designation to sapanisertib for use as a potential therapy in patients with unresected or metastatic sqNSCLC, and whose tumors have an NRF2 mutation.
Rachel E. Sanborn, M.D., medical director, Providence Thoracic Oncology Program and the Phase I Clinical Trials Program, is the principal investigator. Providence is the only site in the Pacific Northwest offering the trial. Get the full details of the study here:
To refer a patient to one of these clinical trials, contact our clinical research office:
New research studies are added frequently. To see more clinical studies, visit:
- Studies for lung cancers
- Studies for many types of cancer and advanced cancers
- All cancer studies at Providence Cancer Institute
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Providence Center of Excellence for precision immuno-oncology and cellular therapy
Since 1993, cancer research has been the primary focus of the Earle A. Chiles Research Institute, the research arm of Providence Cancer Institute of Oregon. Under the leadership of Walter J. Urba, M.D., Ph.D., our team of physicians and scientists work together to improve cancer treatment methods – seamlessly joining lab research and clinical trials with patient care.
Our main area of research is cancer immunotherapy, and with the advancements in genomic sequencing we bring together the power of immunotherapy and personalized medicine to accelerate leading-edge research and groundbreaking discoveries for patients with cancer.