RTX-321 Monotherapy in Patients With HPV 16+ Tumors

  • End date
    Sep 15, 2023
  • participants needed
  • sponsor
    Rubius Therapeutics
Updated on 19 January 2022
platelet count
growth factor
neutrophil count
mitomycin c
growth factors
human papilloma virus vaccine


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.


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.

Condition Cervical Cancer, Head and Neck Cancer, Anal Cancer
Treatment RTX-321
Clinical Study IdentifierNCT04672980
SponsorRubius Therapeutics
Last Modified on19 January 2022


Yes No Not Sure

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-A02:01 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)
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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