Clinical Study

Rtx-321-01 A Phase 1 Study Of Rtx-321 For The Treatment Of Patients With Advanced Malignancies Associated With Human Papillomavirus-16 Infection

Posted Date: Jul 6, 2021

  • Investigator: Amanda Jackson
  • Specialties: Cancer, Oncology
  • Type of Study: Drug

The primary purpose of this study is to determine the safety and tolerability, recommended phase 2 dose and pharmacology, and antitumor activity of RTX-321 in adult patients with persistent, recurrent, or metastatic, unresectable cervical cancer. Efficacy will be measured by Safety Assessment by rate of Adverse Events and Dose limiting toxicities of RTX-321. The study will include a monotherapy dose escalation phase followed by an expansion phase.


Histologically Confirmed Diagnosis By The Local Laboratory Of Persistent, Recurrent, Or Metastatic, Unresectable Cervical Cancer. All Patients With Programmed Death-Ligand 1 (Pd-L1) Positive Cervical Cancer And Those With Hnscc Must Have Received Or Have Been Determined To Be Ineligible For Immunotherapy With A Pd-1 Or Pd-L1 Inhibitor. All Patients With Cervical Cancer Will Have Received Or Have Been Determined To Be Ineligible For Bevacizumab. Confirmation Of Hla-A*02:01 Positive Status By Central Testing. Serum Albumin =2.5 G/Dl. Except In Documented Cases Of Gilbert Syndrome, Total Bilirubin =1.5 × Uln. Serum Or Plasma Creatinine =1.5 × Uln And/Or Glomerular Filtration Rate =50 Ml/Min/1.73 Calculated By The Cockcroft-Gault Formula. Absolute Neutrophil Count =1 × 103/Μl, Without Myeloid Growth Factor Support For =1 Week. Platelet Count =100 × 103/Μl, Without Platelet Transfusion For =1 Week. Hemoglobin =9 G/Dl, Without Red Blood Cell Transfusion For =2 Weeks. No Central Nervous System (Cns) Involvement. No Known Hypersensitivity To Any Component Of Study Treatment Or Excipients. No Positive Antibody Screen. No Clinically Significant, Active And Uncontrolled Infection, Including Human Immunodeficiency Virus (Hiv), Hepatitis B Virus (Hbv), Or Hepatitis C Virus (Hcv).


Phase 1

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