Phase 1/2, Open-label, Dose-escalation Study of ISIS-STAT3Rx, Administered to Patients with Advanced Cancers

Overview

About this study

This is a Phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of patients with advanced cancers. Eligible patients with DLBCL or other advanced lymphomas will be enrolled into the dose-expansion cohort.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Aged 18 years or older
  • Tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists
  • Expansion cohort only: Advanced lymphoma confirmed by histopathology
  • Measurable or evaluable disease according to RECIST for solid tumors or according to IWRC for NHL tumors
  • ECOG Performance Status less than or equal to 2
  • Life expectancy greater than 12 weeks in the opinion of the Investigator

Exclusion Criteria:

  • Any active or uncontrolled infection
  • NYHA Grade II or greater congestive heart failure
  • History of myocardial infarction within 6 months prior to screening
  • Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to screening or 5 half-lives of the therapy, whichever is shorter

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mitesh Borad, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Thomas Witzig, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
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CLS-20115513

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