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BRIEF TITLE: SQ3370 in Patients With Advanced Solid Tumors

A Multicenter Phase 1, Open-Label Study of SQ3370 in Patients With Advanced Solid Tumors


  • Org Study ID: SQ3370-001
  • Secondary ID: 2020-0185
  • NCT ID: NCT04106492
  • NCT Alias:
  • Sponsor: Shasqi, Inc. - Industry
  • Source: Shasqi, Inc.

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of SQ3370 in patients with cancer (solid tumors).

Overal Status Start Date Phase Study Type
Recruiting August 1, 2020 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Safety and tolerability of SQ3370, including determination of the maximum tolerated dose and the recommended Phase 2 dose.

Primary Outcome 1 - Time Frame: 35 Days

Condition:

  • Cancer

Eligibility

Criteria:
Inclusion Criteria:

- Diagnosis of an advanced local or metastatic solid tumor

- Adequate hematologic, hepatic, renal, and coagulation function

- Tumor is the type where published clinical data would suggest that anthracyclines have
cytotoxic activity

Exclusion Criteria:

- Prior exposure to 300 mg/m^2 of Dox HCl or DOXIL / CAELYX ® or 600 mg/m^2 of
Epirubicin HCl

- CHF, severe myocardial insufficiency, or cardiac arrhythmia

- Any of the following within 28 days prior to Cycle 1 Day 1:

- Major surgery, as defined by the Investigator

- Radiotherapy

- Chemotherapy, immunotherapy and/or anticancer therapy (except for small molecule
kinase inhibitors, which are 6 elimination half-lives)

- Currently enrolled in or discontinued from a clinical study involving an
investigational agent or non-approved use of a drug or device, or concurrently
enrolled in any other type of medical research judged not to be scientifically or
medically compatible with this study
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Shasqi Clinical Operations

Phone: 415-800-1376

Email: clinicalstudies@shasqi.com

Locations

Facility Status Contact
Stanford Cancer Center
Palo Alto, California 94304
United States
Recruiting Principal Investigator
415-800-1376
clinicalstudies@shasqi.com
Henry Ford Hospital
Detroit, Michigan 48202
United States
Recruiting Principal Investigator
415-800-1376
clinicalstudies@shasqi.com
Mary Crowley Cancer Research
Dallas, Texas 75251
United States
Recruiting Principal Investigator
415-800-1376
clinicalstudies@shasqi.com
MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting Vivek Subbiah, MD
713-563-0393
VSubbiah@mdanderson.org
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
Australia
Recruiting Principal Investigator
415-800-1376
clinicalstudies@shasqi.com
Royal North Shore Hospital
Sydney, New South Wales 2065
Australia
Recruiting Principal Investigator
415-800-1376
clinicalstudies@shasqi.com