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Brief Title: Phase 1 Study of SQ3370 in Patients With Advanced Solid Tumors

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

INTRODUCTION

  • Org Study ID: SQ3370-001
  • Secondary ID: 2020-0185
  • NTC ID: NCT04106492
  • Sponsor: 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).


  • Overall Status
    Recruiting
  • Start Date
    August 1, 2020
  • Phase
    Phase 1
  • Study Type
    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 - Timeframe: 35 Days

CONDITION

  • Cancer

ELIGIBILITY


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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 415-800-1376

Email: clinicalstudies@shasqi.com

LOCATION

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

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