Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

Summary

To evaluate safety, immunogenicity and anti-tumor responses of intradermally delivered SNS-301 added to ongoing checkpoint inhibitor therapy in ASPH+ locally advanced unresectable or metastatic/recurrent squamous cell carcinoma of the head and neck (SCCHN) patients.

Official Title

An Open-Label, Multi-Center Trial of SNS-301 Added to Pembrolizumab in Patients With ASPH+ Locally Advanced Unresectable or Metastatic/Recurrent Squamous Cell Carcinoma of the Head and Neck

Details

This is a Phase 1/2, open-label, multi-center trial to evaluate the safety, immunogenicity and preliminary clinical efficacy of SNS-301 delivered intradermally in addition to pembrolizumab in patients with ASPH+ locally advanced unresectable or metastatic/recurrent SCCHN. The trial population consists of patients with ASPH+ locally advanced unresectable or metastatic/recurrent SCCHN who are currently receiving pembrolizumab or nivolumab therapy. Patients must have a best response of stable disease (SD) or first evidence of unconfirmed progressive disease (PD) after a minimum of 12 weeks of pembrolizumab or nivolumab therapy. Prior chemotherapy is allowed but not required. Patients receiving nivolumab will be switched over to pembrolizumab at the time of entering this study.

Keywords

Squamous Cell Carcinoma of the Head and Neck Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Pembrolizumab SNS-301 SNS-301 added to pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Signed informed consent.
  2. Be 18 years of age or older.
  3. Have histologically or cytologically documented locally advanced unresectable or metastatic/recurrent ASPH+ SCCHN and currently receiving pembrolizumab or nivolumab for a minimum of 12 weeks with best response of stable disease (SD) or first evidence of progressive disease (PD) based on RECIST 1.1.
  4. Patients receiving first-line pembrolizumab monotherapy prior to this study must be PD-L1 positive.
  5. Patients on nivolumab therapy must be willing to switch over to pembrolizumab therapy.
  6. Have demonstrated intra-tumoral ASPH expression by IHC.
  7. Have measurable disease by RECIST 1.1.
  8. Eastern Cooperative Oncology Group (ECOG) Performance Scale 0-1.
  9. Have a life expectancy of ≥ 3 months.
  10. Be willing to provide a pre-treatment tissue sample.
  11. Demonstrate adequate organ function: hematological, renal, hepatic, coagulation parameters.
  12. . For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two highly effective contraceptive methods during the treatment period and for at least 180 days after the last dose of study treatment. For male patients: Agree that during the period specified above, men will not father a child. Male patients must remain abstinent, must be surgically sterile during the treatment period and for at least 180 days after the last dose of study treatment.

You CAN'T join if...

  1. Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to trial Day 0.
  2. Participated on a clinical trial of an investigational agent and/or investigational device within 28 days prior to Day 0.
  3. Uncontrolled tumor-related pain.
  4. Malignancies other than indications open for enrollment within 3 years prior to Day 0.
  5. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  6. Known hypersensitivity allergy or contraindication to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the PD-1/PD-L1 inhibitor formulation.
  7. Active or history of autoimmune disease or immune deficiency.
  8. History or any evidence of interstitial lung disease.
  9. History of HIV. HIV antibody testing recommended per investigator's clinical suspicion.
  10. . Active hepatitis B (hepatitis B surface antigen reactive) or active hepatitis C (HCV qualitative RNA detected); testing recommended per investigator's clinical suspicion.
  11. . Severe infections within 4 weeks prior to enrollment.
  12. . Received therapeutic oral or IV antibiotics within 2 weeks prior to Day 0.
  13. . History or current evidence of any condition, therapy or laboratory abnormality that in the opinion of the treating investigator might confound the results of the trial.
  14. . Prior allogeneic stem cell or solid organ transplant.
  15. . Known previous or ongoing, active psychiatric or substance abuse disorders that would interfere with the requirements of the trial.
  16. . Treatment with systemic immunomodulating agents (including but not limited to IFNs, IL-2, ipilimumab) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to first dose.
  17. . Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study.

Locations

  • University of California - San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • Washington University accepting new patients
    Saint Louis Missouri 63310 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sensei Biotherapeutics, Inc.
ID
NCT04034225
Phase
Phase 1/2
Study Type
Interventional
Last Updated