Phase 1 First-In-Human (Fih) Study Of Leukocyte Immunoglobulin-Like Receptor B2 (Lilrb2) Inhibitor Monoclonal Antibody (Mab) Jtx-8064, As Monotherapy And In Combination With A Programmed Cell Death Receptor-1 (Pd-1) Inhibitor, In Adult Subjects With Advan
Posted Date: Oct 21, 2021
- Investigator: Amanda Jackson
- Specialties: Cancer, Oncology
- Type of Study: Drug
JTX-8064-101 is a Phase 1, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose of JTX-8064 alone and in combination with a PD-1 inhibitor (PD-1i). Efficacy will be determined by the incidence and severity of dose-limiting toxicities, treatment-emergent adverse events, serious treatment-emergent adverse events, discontinuation due to adverse events, and by the determination of a RP2D for JTX-8064 monotherapy in combination with JTX-8064 or pembrolizumab.
Histologically Or Cytologically Confirmed Advanced/Metastatic Extracranial Solid Tumor Malignancy. Measurable Disease, According To The Recist Version 1.1, That Has Objectively Progressed Since (Or On) Previous Treatment As Assessed By The Investigator. Eastern Cooperative Oncology Group Performance Status 0 Or 1. Predicted Life Expectancy Of = 3 Months. Have Specified Laboratory Values (Obtained = 28 Days Prior To First Dose) In Accordance With The Study Protocol. For Women Of Childbearing Potential (Wocbp): Negative Serum Pregnancy Test During The Screening Period And A Negative Urine Pregnancy Test Up To 24 Hours In Advance Of C1d1. Wocbp And Males Whose Partners Are Wocbp Must Agree To Use A Highly Effective Method Of Birth Control Throughout Their Participation And For 5 Months Following The Last Study Drug Administration. No Concurrent Anticancer Treatment, Either Fda Approved Or Investigational, For The Cancer Being Evaluated In This Study Or For Prior Malignancies. No Prior Infusion Of Jtx-8064, Lilrb2, Or Ilt4-Directed Therapy. No Immunotherapy Or Biologic Therapy < 28 Days Prior To Planned C1d1 Or 5 Half-Lives, Whichever Is Shorter. No Chemotherapy < 21 Days Prior To Planned C1d1, Or < 42 Days For Mitomycin Or Nitrosoureas Or 5 Half-Lives, Whichever Is Shorter. No Targeted Small Molecule Therapy < 14 Days Or 5 Half-Lives, Whichever Is Shorter, Prior To Planned C1d1. No Radiation Therapy < 21 Days Prior To Planned C1d1. No Symptomatic Or Uncontrolled Brain Metastases, Leptomeningeal Disease, Or Spinal Cord Compression Not Definitively Treated With Surgery Or Radiation. No Women Who Are Pregnant Or Breastfeeding Or Who Plan To Become Pregnant/Breastfeed While On Study; Men Who Plan To Father Children During The Study. No Live Vaccines = 30 Days Of C1d1.
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Uc Cancer Center