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
Nimbus 1150-101: A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of NDI-101150 Administered as Monotherapy or in Combination with Pembrolizumab in Patients with Solid Tumors
Principal Investigator: Kurt Demel, MD
Study Sponsor: Nimbus Saturn Inc.
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: I
Purpose of study: The purpose of the study is to look at how effective the study drug NDI-101150 is at treating certain cancer types when it is given as a single drug, or in combination with pembrolizumab (keytruda). The drug works by blocking a protein called HPK1, and this can potentially help the immune system to better recognize and destroy cancer cells. The study is made up of a dose escalation phase, where any solid tumors are accepted, and a dose expansion phase, where only select tumor types are eligible.
Inclusion Criteria:
– Must be 18 years or older at time of signing consent.
– Must have measurable disease via RECIST 1.1.
– Must have recovered from prior therapy (be at Grade 1 or baseline).
– ECOG of 0 – 1.
– Adequate organ function as determined by screening lab tests.
– Female patients that are women of child-bearing potential (WOCBP) must agree to using highly effective contraceptive methods while on study and must have negative serum or urine pregnancy test within 48hrs prior to Cycle 1 Day 1 of study treatment.
– Must be able to swallow study medication.
– Be willing to avoid sun exposure, wear protective clothing, and/or apply sunscreen if sun exposure is unavoidable.
– For Dose Escalation portion of the study: must have advanced or metastatic solid tumors for which no standard therapies are available or must be refractory to standard therapy.
The Following inclusion criteria are for the dose expansion phase, and are in addition to the criteria listed above:
– Must be willing to consent to required tissue biopsy.
– Must have advanced or metastatic Gastric/Gastroesophageal junction, Non-small cell lung cancer, or Renal Cell Carcinoma for which there is no standard therapy available.
– Additional criteria may apply and will be discussed with the physician and study team.
Exclusion Criteria:
– Had a previous solid organ or hematopoietic stem cell transplant.
– Central Nervous System disease that is previously untreated or requires steroids or other intervention.
– Prior anti-cancer treatment that includes the following: Systemic anticancer treatment – chemotherapy, antibody or other anticancer therapy less than 4 weeks prior to first dose of study treatment. Radiation therapy, stereotactic body radiation, chemoembolization, small molecule therapy or targeted therapies.
– Significant cardiovascular disease: myocardial infarct/stroke, or unstable angina within 3 months prior to study treatment, Congestive Heart Failure, uncontrolled hypertension, or history of significant ventricular arrhythmias.
– History of severe immune-related adverse events that led to stopping of prior immunotherapy.
– History of severe hypersensitivity reaction to treatment with monoclonal antibodies.
– If patient requires corticosteroids >10mg/day prednisone or equivalent within 14 days prior to day 1. (Some exceptions may apply
– History of lung disease, pneumonitis, or pneumonia on chest scan within the last 6 months.
– Major surgery within 4 weeks prior to starting study drug, or if patient has not recovered from effects of the prior surgery.
– Uncontrolled active infection that requires IV antibiotics, antiviral, or antifungal medication within 14 days prior to study treatment.
– Known additional active malignancy that is requiring treatment (excluding basal cell, or squamous cell skin cancer, or other cancer for which patient has been disease free for more than 2 years).
– Active HIV infection, or Hepatitis B or C infection.
– Known current alcohol or drug abuse.
– unstable or uncontrolled condition, psychiatric illness, or abnormal lab finding that, in the opinion of the physician, would increase the risk to the patient.
– Prior treatment with an HPK1 inhibitor.
– Taking any contraindicated medications that cannot be discontinued prior to starting study drug.
– Additional criteria may apply and will be discussed with the physician and study team.
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
XTX301-01/02-001: A First-in-Human, Multicenter, Phase 1, Open-Label Study of XTX301 in Patients With Advanced Solid Tumors
Principal Investigator: Jayanthi Vijayakumar, MD
Study sponsor: Xilio Development Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: I
Purpose of study: The main purpose of this study is to determine if XTX301 is safe and well-tolerated in participants with advanced solid tumors. This is the first time XTX301 is going to be given to humans, so this study will also serve to determine the recommended XTX301 dose and schedule in later clinical studies.
Inclusion Criteria:
– Patient must be at least 18 years or older at time of consent.
– Must meet the following disease criteria:
a. Part 1A – any confirmed solid tumor that is locally advanced or metastatic that has failed standard treatments, or for which there is no standard therapy available.
b. Part 1B – Locally advanced or metastatic tumor that is any of the following: Melanoma, non-small cell lung cancer (NSCLC), Head and Neck Squamous cell, Triple-negative breast (TNBC), Cervical cancer, MSI-H/dMMR colorectal, or MSI-H/dMMR endometrial cancer.
– Patient must not have received prior anticancer therapy for at least 28 days prior to starting study treatment, and must have returned to baseline or grade 1 for any side effects from previous therapy.
– Must have ECOG of 0-2.
– Patient must have adequate organ function as determined by local lab tests.
– For Part 1B only: patients must be willing to undergo a tumor biopsy before starting, and while on study treatment.
– Women of Childbearing Potential (WOCBP) must be willing to abstain from sexual activity, or use highly effective contraception. Additionally, must also have a negative serum pregnancy test at the time of study enrollment and before each dose of study drug.
– Additional criteria may apply and will be discussed with the physician and study team.
Exclusion Criteria:
– Must not have had previous treatment with IL-12 therapy
– Patients with known liver metastasis are excluded, unless previous discussion between treating physician and study medical monitor approves the patient to enroll.
– Concurrent anticancer therapy, immune therapy, or cytokine therapy, or other antineoplastic therapy during the study.
– History of significant pulmonary disease, interstitial lung disease or pulmonary fibrosis.
– History of significant heart disease, uncontrolled hypertension, congestive heart failure, or myocarditis.
– Possible area of non-disease related necrosis, such as an active ulcer, a non-healing wound, or intercurrent bone disease.
– Has active central nervus metastases, or carcinomatous meningitis.
– Active autoimmune disease that required therapy in the past 2 years, including use of corticosteroids, or immunosuppressive drugs.
– Has an active infection that requires systemic therapy within 4 weeks prior to receiving study drug.
– Has a history of Grade 3 or higher immune-related toxicities from prior immunotherapy unless it resolved within 14 days.
– Has had history of severe hypersensitivity to monoclonal antibodies
– Is pregnant or breastfeeding.
– Has active hepatitis B or C infection.
– Has had prior gene therapy treatment, organ transplant, or hematopoietic stem-cell transplant.
– Is currently using or has received another investigational drug or device within 4 weeks prior to starting study drug.
– Has received a live or live-attenuated vaccine within 4 weeks prior to first dose.
– Additional exclusion criteria may apply and will be discussed with the physician and study team.
Study Contact:
Alissa Gavenda, RN
(952) 993-6705
Alissa.Gavenda@ParkNicollet.com
