RTX-321 Monotherapy in Patients With HPV 16+ Tumors

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Brief Title

RTX-321 Monotherapy in Patients With HPV 16+ Tumors

Official Title

A Phase 1 Study of RTX-321 for the Treatment of Patients With Advanced Malignancies Associated With Human Papillomavirus-16 Infection

Brief Summary

      This is an open-label, multicenter, multiple-ascending dose, FIH, Phase 1 study of RTX-321
      for the treatment of patients that are HLA-A*02:01 positive with persistent, recurrent, or
      metastatic, unresectable, HPV 16+ cancers.

Detailed Description

      This is a Phase 1, open label, multicenter, multidose, first-in-human (FIH) dose escalation
      and expansion 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 (squamous, adeno, or adenosquamous histology),
      HNSCC, or squamous cell cancer of the anal canal that is not amenable to curative therapy.
      Prior to study screening, all patients must be confirmed to be HLA-A*02:01 positive.
      Documentation of an HPV 16+ tumor is required at prescreening for patients with cervical
      cancer and HNSCC. RTX-321 is a cellular therapy that expresses 4-1BBL, IL-12, and HPV-16
      Antigen with the goal of harnessing the innate and adaptive immune systems for the treatment
      of cancer. The study will include a monotherapy dose escalation phase followed by an
      expansion phase.

Study Phase

Phase 1

Study Type


Primary Outcome

Safety Assessment by rate of Adverse Events:

Secondary Outcome

 Pharmacodynamics (PD) of RTX-321:


Cervical Cancer



Study Arms / Comparison Groups

 RTX-321 Dose Escalation
Description:  Phase 1: RTX-321 administered intravenously on Day 1 of each cycle monotherapy dose escalation


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

April 8, 2021

Completion Date

September 15, 2023

Primary Completion Date

August 15, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Signed written informed consent obtained prior to study procedures Patients ≥18 years
             with an ECOG 0 or 1

          -  Histologically confirmed diagnosis by the local laboratory of persistent, recurrent,
             or metastatic, unresectable cervical cancer (squamous, adeno, or adenosquamous
             histology), HNSCC, or squamous cell cancer of the anal canal that is not amenable to
             curative therapy.

          -  All patients must have experienced disease progression following platinum-based or
             mitomycin C-based chemotherapy administered in the persistent, recurrent, or
             metastatic setting.

          -  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.

          -  In patients with cervical cancer or HNSCC, confirmation of HPV 16 within the tumor
             either from historical pathology result (using an FDA-approved HPV testing method,
             patients with cervical cancer only) or based on central laboratory analysis of a tumor
             sample. Patients with anal cancer will not be required to have prospective
             determination of HPV 16 positive status prior to enrollment.

          -  Disease must be measurable per Response Evaluation Criteria

          -  The shorter of 28 days or 5 half-lives must have elapsed since the completion of prior
             therapy, before initiation of study treatment.

          -  Adequate Organ Function as Defined by the protocol:

               -  AST and ALT ≤3 × the upper limit of normal (ULN)

               -  Except in documented cases of Gilbert syndrome, total bilirubin ≤1.5 × ULN

               -  Serum albumin ≥2.5 g/dL

               -  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

        Exclusion Criteria:

          -  Patient has central nervous system (CNS) involvement. If the patient fulfills the
             following 3 criteria, she/he is eligible for the trial after consultation with the
             Sponsor Medical Monitor.

               -  Completed prior therapy for CNS metastases (radiation and/or surgery)

               -  CNS tumor(s) is clinically stable at the time of enrollment

               -  Patient does not require corticosteroid or antiepileptic therapy for management
                  of CNS metastases

          -  Known hypersensitivity to any component of study treatment or excipients.

          -  Positive antibody screen using institution's standard type and screen test.

          -  Clinically significant, active and uncontrolled infection, including human
             immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).




18 Years - N/A

Accepts Healthy Volunteers



, 617-679-9600, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Rubius Therapeutics

Study Sponsor

, , 

Verification Date

December 2020