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
XTX202 in Patients With Advanced Solid Tumors (XTX202-01: A study of XTX202 as single drug in Patients With Advanced Solid Tumors)
Principal Investigator: Randy Hurley, MD
Study sponsor: Xilio Development, Inc.
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: I/II
Purpose of study: This is a first-in-human study that is looking to test the safety and maximum tolerated dose of experimental drug XTX202 as a single treatment. The study is composed of 2 parts; Phase 1 (dose escalation) that is focused on finding the highest tolerated dose, and Phase 2 – which is split up into Phase 2a (patients with renal cell cancer), and Phase 2b (patients with melanoma). Phase 1 is open to multiple advanced solid tumors.
Inclusion Criteria:
Phase 1:
– Confirmed locally advanced or metastatic solid tumor that failed standard therapy.
Phase 2a:
– Patients with metastatic renal cell carcinoma that have been previously treated with Anti-PD-1 or TKI. They must have progressed on anti-PD-1 mAb as single drug or in combination with other therapies.
Phase2b:
– Unresectable or metastatic melanoma previously treated with Anti-PD-1 or anti-CTLA4 checkpoint inhibitors.
– ECOG of 0-1
– Adequate organ function
Exclusion Criteria:
– Received prior treatment with IL-2 therapy
– History of clinically significant pulmonary disease
– History of clinically significant cardiovascular disease
– Has a diagnosis of immunodeficiency
– Has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs
– Has an active infection requiring systemic therapy within 4 weeks prior to study treatment
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1817
Lisa.Wahowske@parknicollet.com
