18-BI-1206-03: Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody CD32b (FcƴRIIB) in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors Previously Treated with Anti-PD-1 or Anti-PD-L1 Antibodies
Principal Investigator: Yan Ji, MD
Study Sponsor: BioInvent International AB
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase 1
Purpose of study: The purpose of the study is to see if a medicine not yet approved by the FDA, named BI-1206, will help in the treatment of advanced solid tumors and also how safe it is for people to use in combination with pembrolizumab, which is an approved drug under the trade name of Keytruda.
There are 2 parts to this study: Part 1 (dose escalation) Part 2 (dose expansion). When enrollment is completed to Part 1 then Part 2 (dose expansion) will open.
Inclusion Criteria:
– At least 18 years of age on day of signing informed consent.
– Has a histologically confirmed advanced solid tumor.
– Must have received at least 2 doses of an approved anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies, and have documented progression on or within 12 weeks from the last dose of anti-PD-1/L1 mAb.
– Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.
– Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1206 (on non-previously irradiated lesions only). The biopsy must be performed at least 4 weeks following the last dose of tumor-directed therapy.
– Has an ECOG performance status of 0-1.
– Has adequate organ function as confirmed by laboratory values.
– Has a life expectancy of at least 12 weeks.
Exclusion Criteria:
– Needs doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.
– Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated CNS metastases may participate provided they are radiologically stable.
– Has cardiac or renal amyloid light-chain amyloidosis.
– Has received chemotherapy or small molecule products within 4 weeks of first dose of BI-1206.
– Has received radiotherapy within 2 weeks of first dose of BI-1206.
– Has received immunotherapy within 4 weeks prior to the first dose of BI-1206.
– Has an active, known or suspected autoimmune disease.
– Has had an allogenic tissue/solid organ transplant.
– Has uncontrolled or significant cardiovascular disease.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
Piqray CGM IIT: Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib (CBYL719A0US16T)
Principal Investigator: Dylan Zylla, MD, Richard Bergenstal, MD
Study sponsor: HealthPartners Institute
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: II
Purpose of study: The purpose of the study is to characterize and understand the impact of alpelisib on glucose control in patients with breast cancer using Continuous Glucose Monitoring (CGM) and following a hyperglycemia prevention and management regimen.
Inclusion Criteria:
– Adults age 18+ with diagnosis of metastatic Breast cancer that are initiating treatment with Alpelisib.
– Must be willing to and comply with study visits and procedures.
– Must meet standard clinical criteria for utilizing Alpelisib, including Hormone-receptor positive/HER2 negative cancer with presence of PIK3CA mutation.
– Treating oncologist must plan to use Alpelisib until disease progression or unacceptable toxicity.
– Patient must receive cancer care with a HealthPartners Oncologist during Alpelisib treatment phase and must be willing to see IDC/HealthPartners Diabetes Education for diabetes management.
– Must have compatible smartphone, access to compatible smartphone, or ability to digitally upload information from Continuous Glucose Monitor (CGM), or to bring the reader in to the medical visit at least once a month for uploading data.
– Must have life expectancy of at least 3 months.
Exclusion Criteria:
– Has known history or allergy to skin-adhesive material, or previous cutaneous reaction to a continuous glucose monitor.
– Known currently uncontrolled diabetes, defined as most recent HbA1c over 10%, or history of DKA within 6 months prior to enrollment.
– Concurrent use of high-dose vitamin C, defined as more than 1g of oral vitamin C daily, or IV vitamin C infusions.
– Any concurrent severe, or uncontrolled condition that, in the opinion of the investigator, would cause safety risk, compromise protocol compliance, or contraindicate patient’s participation in the study.
Study Contact:
Alissa Gavenda, RN
(952) 992-5705
Alissa.Gavenda@ParkNicollet.com
Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss (EPIK-B3)
Principal Investigator: Dylan Zylla, MD
Study sponsor: Novartis
Location: HealthPartners Frauenshuh Cancer Center, HealthPartners Cancer Center at Regions Hospital
Phase of Study: III
Purpose of study: The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel (Abraxene) is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2).
Inclusion Criteria:
– Participant is ≥ 18 years old at the time of informed consent
– Participant has confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy, or metastatic (stage IV)) TNBC and meets the following criteria;
a. HER2 negative in situ hybridization (ISH) test or an immunohistochemistry (IHC) status of 0 or 1+, and
b. ER and PR expression is <1 percent as determined by IHC
– Participant has either:
a. Measurable disease, i.e., at least one measurable lesion per RECIST 1.1 criteria (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation) OR
b. If no measurable disease is present, then at least one predominantly lytic bone lesion or mixed lytic-blastic bone lesion with identifiable soft tissue component (that can be evaluated by Computerized Tomography (CT) /Magnetic Resonance Imaging (MRI)) must be present. Subjects with no measurable disease and only one predominantly lytic bone lesion that has been previously irradiated are eligible if there is documented evidence of disease progression of the bone lesion after irradiation.
– Participant has adequate tumor tissue for analysis of PIK3CA mutation and PTEN loss status by a Novartis designated lab. A formalin embedded (FFPE) tumor block from a new OR archival biopsy OR unstained FFPE glass slides must be provided. If archival tumor sample is not available, then a new or recent biopsy is required;
a. if PIK3CA mutation is detected, then subject may be eligible for Part A, if all other criteria met
b. If PTEN loss w/out PIK3CA mutation detected, then patient may be eligible for Part B1 or B2 if all other criteria are met
c. If PTEN loss detected, and PIK3CA status is unknown, then participant may be eligible for Part B1 if all other criteria is met
– Participant has ECOG status of 0 – 1.
– Participant has received no more than one line of therapy for metastatic disease.(Participants with de novo metastatic disease are eligible.)
a. Participant may have received prior taxane-based chemotherapy in the neoadjuvant or adjuvant setting, provided that it has been completed at least 12 months prior to Day 1 of Cycle 1.
b. Participant may have received prior taxane-based chemotherapy for metastatic disease as long as best response has not been progressive disease, and has been completed at least 12 months prior to Day 1 of Cycle 1.
– Participant has adequate bone marrow and organ function based on appropriate lab values
**These inclusion criteria will be discussed in further detail with the provider
Exclusion Criteria:
Participant with the following;
– received prior treatment with any PI3K, mTOR, or AKT Inhibitor
– has known hypersensitivity to Alpelisib, nab-paclitaxel, or any of their excipients
– Participant with inflammatory breast cancer at screening.
– concurrently using other anti-cancer therapy.
– has not recovered from all toxicities related to prior anti-cancer therapies back to a grade 1 based on NCI CTCAE guidelines. (Exception to this criteria is: patients with any grade alopecia are allowed to enter study)
– with Child Pugh score B or C.
– has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to randomization, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia).
– has a concurrent malignancy or malignancy within 3 years prior to start of study treatment, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer, or curatively resected cervical cancer.
– has central nervous system that was not previously treated or newly detected at screening
– has established diagnosis of Diabetes Mellitus type 1 or uncontrolled type 2.
– has impaired GI function or GI disease that may affect the absorption of study drug.
– has history of pancreatitis within 1 year
– concurrent severe or uncontrolled medical condition that would contraindicate the patient’s participation in the study (in the investigator’s judgement)
– currently documented pneumonitis/interstitial lung disease
– clinically significant heart disease or recent cardiac events, including the following; history of angina pectoris, coronary artery bypass graft (CABG), symptomatic pericarditis, myocardial infarct within 6 months prior to start of study treatment, documented congestive heart failure (CHF), LVEF <50% at screening as determined by MUGA or ECHO, clinically significant cardiac arrhythmia, Long QT or family history of Long QT or Fridericia’s QTcF > 470ms at screening, Uncontrolled hypertension.
– has history of cutaneous reactions
– unresolved osteonecrosis of the jaw
– participant is receiving CYP3A3 or BCRP inhibitors and cannot discontinue 7 days prior to initiating study treatment
– currently receiving systemic corticosteroids within 2 weeks of starting study drug.
– has had prior investigational drug within 30 days prior to study start
– if participant is unable to understand or comply w/ study instructions or requirements
– participant is woman of child-bearing potential that is capable of becoming pregnant unles using highly effective contraception during study treatment and for 6 months after last dose.
– Sexually active male unwilling to use contraceptives during intercourse and for 6 months after last dose
– is a nursing (lactating) or pregnant woman as confirmed by positive serum (hCG) test prior to starting study treatment
Study Contact:
Alissa Gavenda
(952) 993-6705
Alissa.Gavenda@ParkNicollet.com