Principal Investigator:
Study sponsor: Inhibrx, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: 1/2
Purpose of study: The purpose of the study is to determine the safety and tolerability of the study drug INBRX-106. INBRX-106 works by activating OX40, which is a stimulant for the immune system. If INBRX-106 works, it should stimulate your immune system, which in turn can help your body fight the tumor. This mechanism is similar to CTLA-4, PD-1 or PD-L1 blocking antibodies (called immune checkpoint inhibitors), which have been approved by the FDA for the treatment of certain tumors.
Inclusion Criteria:
– Must be age 18 or older at time of signing informed consent.
– Tumor types included:
Part 4 (study drug in combination with Pembrolizumab) – Cohort F3: non-small cell lung cancer that has had no more than 2 lines of standard therapy including at least 1 anti-PD1/L1 drug. Cohort F4: Checkpoint inhibitor naïve with confirmed Head and neck squamous cell carcinoma, or confirmed nasopharyngeal carcinoma. Must have been treated with 0-1 prior lines and HNSCC patients, minimum of 4 must provide fresh biopsies. Cohort F7 – NSCLC.
– Must have PD-L1 tests available or provide tissue for PD-L1 testing at screening to be eligible. At least 50% TPS score for Cohorts C3 and F3. At least 1% for cohort F4, and 0% + is acceptable for Cohort F7.
– Must have measurable disease by RECIST 1.1
– Adequate organ function as determined by local lab tests.
– ECOG of 0-1.
– Patients must agree to highly effective methods of contraception or abstinence during and 4 months after the last dose of study drug.
Additional criteria may apply and will be discussed with the physician and study team.
Exclusion Criteria:
– Prior exposure to OX40 agonists.
– For part 4 cohort F4 only: prior exposure to anti-PD-1/PD-L1 checkpoint inhibitors in the relapsed or metastatic setting.
– received any investigational or approved anticancer drug within 4 weeks prior to first dose of study drug. (Hormone replacement therapy is allowed).
– Radiotherapy within 2 weeks prior to first dose. 1-week washout is permitted for palliative radiation to non-CNS disease.
– Allergy to INBRX-106 or known allergies to antibodies produced from Chinese Hamster ovary cells which could suggest increased potential for hypersensitivity to study drug.
– Hypersensitivity to pembrolizumab or any of its excipients, to chemo agents, or to folic acid or vitamin B12.
– Hematologic malignancies
– For patients with NSCLC:
- cohorts F3 and F7: Received radiation therapy to lung >30Gy within 6 months prior to first dose
- F3 + F7: patients with non-squamous NSCLC with EGFR mutations or ALK gene rearrangements
- Cohort F7: unable to take folic acid or vitamin B12 supplements. Squamous histology is excluded. Mixed is allowed is the predominant type is non-squamous. Also excluded if small cell elements are present.
– Has known active CNS metastases or carcinomatous meningitis. Patients with previously treated brain mets are able to participate provided they are radiologically stable and without evidence of progression for 4 weeks, and also do not require corticosteroids for at least 14 days prior to first dose of study drug.
– Prior or concurrent malignancies. Some exclusions are allowed after discussion between physician and study medical monitor.
– Grade 3 or higher immune-related adverse event that resulted in discontinuation of prior therapy.
– Active or documented autoimmune disease that requires systemic steroids or immunosuppressive medications. (hormone replacement therapy is an exception and is allowed).
– immunodeficiency or treatment with systemic immunosuppressive medication within 7 days prior to first dose of study drug.
– Patients that received granulocyte colony-stimulating factor or erythropoietin within 14 days prior to first dose.
– history of Hepatitis B or C, or HIV.
– HIV patients must be on anti-retroviral therapy, and have controlled HIV disease at time of screening.
– Subjects with past or ongoing HCV infection are eligible if completed treatment 1 month prior to starting study drug and have negative HCV RNA test at screening.
– Clinically significant cardiac condition.
– Active interstitial lung disease, pneumonitis, or history of, requiring treatment with immunosuppressive meds or steroids.
– Pulmonary embolism within 12 weeks prior to first dose.
– Major surgery within 4 weeks prior to first dose.
– Active infection requiring systemic therapy within 4 weeks prior to first dose.
– Pregnant or nursing.
– Prior allogenic organ transplant or stem cell/bone marrow transplant.
– Live vaccine within 4 weeks prior to first dose of study drug.
– Any known documented or suspected history of substance abuse that in the opinion of the physician would interfere with the patient’s ability to adhere to study required visits and requirements.
Additional criteria may apply and will be discussed with the physician and study team.
Additional criteria may apply and will be discussed with the physician and study team.
Study Contact:
Alissa Gavenda, RN
(952) 992-5705
Alissa.Gavenda@ParkNicollet.com
