Study of SQZ-AAC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
SQZ Biotechnologies
Study ID
NCT04892043
Phase
PHASE1
Status
Terminated

Conditions

  • Adult Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SQZ-AAC-HPV — BIOLOGICAL
    Activating antigen carriers (AACs) cell therapy; therapeutic vaccine engineered from red blood cells manufactured with immunogenic epitopes of HPV16
  • Ipilimumab — DRUG
    Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) blocking antibody
  • Nivolumab — DRUG
    Programmed cell death 1 (PD-1) blocking antibody

Study Details

This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-AAC-HPV as monotherapy and in combination with immune checkpoint inhibitors in HLA-A\*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (HPV16+) solid tumors. The study includes patients with anal, rectal, cervical, head and neck, penile, vulvar, or vaginal cancer.

Key Dates

Start date
Aug 19, 2021
Status verified
Feb 2024
Primary completion
Nov 2, 2023
Completion
Nov 2, 2023

Study Design

Enrollment
5 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Monotherapy Dose Escalation Phase
    In Part 1, SQZ-AAC-HPV as a monotherapy is administered every 3 weeks for up to a year. There are 3 groups ("Cohorts") in this Phase as follows: * Cohort 1a: low dose SQZ-AAC-HPV * Cohort 1b: high dose SQZ-AAC-HPV * Cohort 1c: higher or lower dose SQZ-AAC-HPV
  • Experimental: Part 2 Combination Safety Phase
    In Part 2, SQZ-AAC-HPV in combination with immune checkpoint inhibitors (1) ipilimumab, (2) nivolumab, or (3) nivolumab plus ipilimumab is administered every 3 weeks up to a year, but the immune checkpoint inhibitors may be administered up to 2 years. There are 3 groups ("Cohorts") in this Phase as follows: * Cohort 2a: SQZ-AAC-HPV RP2D (Recommended Phase 2 Dose) plus ipilimumab * Cohort 2b: SQZ-AAC-HPV RP2D plus nivolumab * Cohort 2c: SQZ-AAC-HPV RP2D plus nivolumab and ipilimumab

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0 [ Time Frame: Up to 1 year after LPFV (Last Patient, First Visit) ]

Locations (6)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Oregon Health & Science UniversityPortlandOregon97239-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CAUC San Diego Moores Cancer Center· La Jolla, CABarbara Ann Karmanos Cancer Institute· Detroit, MIRoswell Park Comprehensive Cancer Center· Buffalo, NYIcahn School of Medicine at Mount Sinai· New York, NYOregon Health & Science University· Portland, OR

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