RTX-321 Monotherapy in Patients With HPV 16+ Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04672980|
Recruitment Status : Terminated (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).)
First Posted : December 17, 2020
Last Update Posted : December 8, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Head and Neck Cancer Anal Cancer||Drug: RTX-321||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of RTX-321 for the Treatment of Patients With Advanced Malignancies Associated With Human Papillomavirus-16 Infection|
|Actual Study Start Date :||April 8, 2021|
|Actual Primary Completion Date :||November 30, 2022|
|Actual Study Completion Date :||November 30, 2022|
Experimental: RTX-321 Dose Escalation
Phase 1: RTX-321 administered intravenously on Day 1 of each cycle monotherapy dose escalation
Experimental: RTX-321 Dose Expansion
Phase 1: RTX-321 administered intravenously on Day 1 of each cycle.
- Safety Assessment by rate of Adverse Events: [ Time Frame: up to 30 months ]Measured by incidence of Treatment Emergent Adverse Events (TEAEs)
- Dose limiting toxicities (DLTs) of RTX-321: [ Time Frame: up to 30 months ]As determined by incidence and severity of adverse events (AEs)
- Pharmacodynamics (PD) of RTX-321: [ Time Frame: up to 30 months ]As measured by the changes in number of CD8+ T-cells in peripheral blood using flow cytometry
- Pharmacokinetics (PK) of RTX-321: [ Time Frame: up to 30 months ]As measured by the detection of the number of RTX-321 cells using flow cytometry
- Anti-tumor activity of RTX-321 [ Time Frame: up to 30 months ]measured by duration of response (DoR)
- Anti-tumor activity of RTX-321 [ Time Frame: up to 30 months ]Measured by overall survival (OS)
- Anti-tumor activity of RTX-321 [ Time Frame: up to 30 months ]Measured by progression free survival (PFS)
- Anti-tumor activity of RTX-321 [ Time Frame: up to 30 months ]Measured by overall response rate (ORR)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04672980
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35249|
|United States, California|
|The Angeles Clinic & Research Institute|
|Los Angeles, California, United States, 90025|
|United States, Colorado|
|University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Laura & Isaac Perlmutter Cancer Center at NYU Langone Health|
|New York, New York, United States, 10016|
|United States, Oklahoma|
|OU Health Stephenson Cancer Center|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|UPMC Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|United States, Virginia|
|Virginia Cancer Specialists|
|Fairfax, Virginia, United States, 22031|
|Responsible Party:||Rubius Therapeutics|
|Other Study ID Numbers:||
|First Posted:||December 17, 2020 Key Record Dates|
|Last Update Posted:||December 8, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases