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
Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
Principal Investigator: Dylan Zylla, MD
Study Sponsor: Celgene
Location: HealthPartners Frauenshuh Cancer Center, HealthPartners Cancer Center at Regions Hospital
Purpose of Study: This is an observational (non-interventional) study, meaning there is no drug or treatment being provided as part of the study. As the patient, you will receive standard of care and routine clinical practice, with the purpose of the study being to capture patient characteristics, practice patterns, and different treatment strategies when treating the following types of lymphoma; Relapsed/refractory (R/R), diffuse large B-cell lymphoma (DLBCL), R/R Follicular lymphoma (FL), and primary mediastinal b-cell lymphoma (PMBCL). Additionally, patient-reported health-related quality of life (HRQoL) outcomes will be collected from patients.
Inclusion Criteria:
- Must be ≥18 years of age at the time of consent
- Must have 1 of the following histologically confirmed Non-Hodgkin Lymphoma (NHL) subtypes: Diffuse Large B-cell lymphoma (DLBCL), NOS; or DLBCL High-grade lymphoma, NOS, or DLBCL high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma)
(Epstien-Barr virus-positive or composite DLBCL are allowed)
Follicular lymphoma (FL)
Primary mediastinal B-cell lymphoma (PMBCL) - Must have been previously treated with at least 1 or more prior systemic therapy (i.e. chemotherapy, immunotherapy, chemoimmunotherapy)
- For first relapsed/refractory (R/R) DLBCL, participant must have confirmed second R/R disease during or after 2L systemic treatment and must have started 3L systemic treatment within 60 days prior to enrolling.
- For second R/R DLBCL cohort, participant must have confirmed second R/R disease or after 2L systemic treatment and must have started 3L treatment within 60 days of enrollment
- For first R/R FL cohort, participant must have confirmed R/R disease (grade 1 to 3B or transformed) and must have initiated 2L systemic treatment ≤ 60 days prior to enrollment
- For first R/R PMBCL cohort, participant must have confirmed first R/R disease during or after 1L systemic treatment and must have initiated 2L systemic treatment ≤ 60 days prior to enrollment
- Participant must be willing and able to complete enrollment and follow-up health-related quality of life (HRQoL) and social support instruments
- Participants volunteering for the Tissue Sub-Study must consent for use of their blood/tumor biopsies, which were collected as per standard of care, for exploratory analyses.
- These criteria can further be discussed with the physician or study team.
Exclusion Criteria:
- Participant whose prior start and end date of DLBCL, FL, or PMBCL treatment, and prior treatment received, including chemotherapy, radiation, surgery (not including excisional biopsies), and other anticancer therapy, are unknown
- Participant who has any other active malignancy (non-DLBCL, non-PMBCL, or non-FL) for which the participant is receiving treatment at the time of enrollment or any other former malignancy that was diagnosed within 6 months prior to Registry enrollment (with the exception of non-melanoma skin cancer)
- Currently enrolled in any interventional clinical trial where the participant is being treated with an investigational product that cannot be identified.
Study Contact:
Jordan Cowger
(952) 993-6071
Jordan.Cowger@parknicollet.com
