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Cervical CancerPhase 1NCT04672980

RTX-321 Monotherapy in Patients With HPV 16+ Tumors

A Phase 1 study testing RTX-321 in people with Cervical Cancer and Head and Neck Cancer, run by Rubius Therapeutics at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cervical Cancer, Head and Neck Cancer, Anal Cancer
What is being tested?
RTX-321
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
10 sitesUnited States
Study dates
8 Apr 2021to 30 Nov 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 17Show fewer
  • 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

Who cannot join

  • 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).

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • University of Alabama

    Birmingham, Alabama, 35249

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • The Angeles Clinic & Research Institute

    Los Angeles, California, 90025

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
RTX-321
Medical subject headings
Uterine Cervical Neoplasms, Head and Neck Neoplasms, Anus Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RTX-321Drug

    RTX-321 monotherapy

Study groups in NCT04672980
Study groupRoleWhat they receive
RTX-321 Dose EscalationExperimentalPhase 1: RTX-321 administered intravenously on Day 1 of each cycle monotherapy dose escalation
Receives: Drug: RTX-321
RTX-321 Dose ExpansionExperimentalPhase 1: RTX-321 administered intravenously on Day 1 of each cycle.
Receives: Drug: RTX-321

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Assessment by rate of Adverse Events:

    Measured by incidence of Treatment Emergent Adverse Events (TEAEs)

    Measured: up to 30 months

  2. Dose limiting toxicities (DLTs) of RTX-321:

    As determined by incidence and severity of adverse events (AEs)

    Measured: up to 30 months

Secondary outcomes (6)

  1. Pharmacodynamics (PD) of RTX-321:

    As measured by the changes in number of CD8+ T-cells in peripheral blood using flow cytometry

    Measured: up to 30 months

  2. Pharmacokinetics (PK) of RTX-321:

    As measured by the detection of the number of RTX-321 cells using flow cytometry

    Measured: up to 30 months

  3. Anti-tumor activity of RTX-321

    measured by duration of response (DoR)

    Measured: up to 30 months

  4. Anti-tumor activity of RTX-321

    Measured by overall survival (OS)

    Measured: up to 30 months

  5. Anti-tumor activity of RTX-321

    Measured by progression free survival (PFS)

    Measured: up to 30 months

  6. Anti-tumor activity of RTX-321

    Measured by overall response rate (ORR)

    Measured: up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start8 Apr 2021
  3. Primary completion30 Nov 2022
  4. Study completion30 Nov 2022

Why it stopped: The Sponsor terminated study after dosing 3 dose groups (9 pts) and closed trial on 11/30/22. RTX-321 was well-tolerated with no DLTs, no related deaths, SAEs or Gr. 3/4 AEs and cleared from circulation rapidly (w/in 10 min).

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04672980
Sponsor's protocol ID
RTX-321-01
Status last verified
Dec 2022
First submitted
8 Dec 2020
Last updated
8 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RTX-321 in people with Cervical Cancer and Head and Neck Cancer, run by Rubius Therapeutics at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The Sponsor terminated study after dosing 3 dose groups (9 pts) and closed trial on 11/30/22. RTX-321 was well-tolerated with no DLTs, no related deaths, SAEs or Gr. 3/4 AEs and cleared from circulation rapidly (w/in 10 min).). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Assessment by rate of Adverse Events: (time frame: up to 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04672980.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.

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