CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
PAN-301-1biological
Likely dose
Not stated in record
Key inclusion· 7
  • Men aged 21–85 years with histologically confirmed prostate cancer and biochemical relapse after definitive local therapy (surgery or radiation).
  • Biochemically relapsed disease defined as PSA >2 ng/mL 1 year post-treatment, or PSA doubling time <12 months, or PSA velocity >2 ng/mL/year.
  • Positive HAAH expression in archived tumor tissue or fresh serum.
  • No clinical or radiologic evidence of distant metastatic disease on pelvic MRI/CT or bone scan (within 56±7 days of study start).
Key exclusion· 8
  • PSA doubling time <3 months.
  • Prior major surgery or radiation therapy within 4 weeks of enrollment.
  • Prior cytotoxic chemotherapy for current cancer.
  • Active autoimmune disease (requiring immune suppressive or cytoreductive therapy currently or within 1 year).

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03120832
NCT03120832Phase 1Completed

Phase 1, Open Label Trial to Evaluate the Safety and Immunogenicity of PAN-301-1 in Cancer Patients

Sensei Biotherapeutics, Inc.·interventional·Posted Apr 19, 2017·Updated Nov 12, 2021

In Brief

A Phase 1 clinical trial evaluating PAN-301-1 for Prostate Cancer. Completed, enrolled 12 participants across 4 sites.

Detailed Summary

This is a Phase I, open-label, parallel design study of PAN-301-1 (SNS-301), a HAAH directed nanoparticle vaccine, given intradermally in cohorts of patients with biochemically relapsed prostate cancer, using a fixed dose escalation schema every 21 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsAccelovance

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 19, 2017
Enrollment StartDec 1, 2016
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 9.2 years ago

Interventions

PAN-301-1biological