Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 1 Study of SQ3370 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04106492
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Cancer Drug: SQ3370 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase 1, Open-Label Study of SQ3370 in Patients With Advanced Solid Tumors
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2023


Arm Intervention/treatment
Experimental: SQ3370 Drug: SQ3370
SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin




Primary Outcome Measures :
  1. Safety and tolerability of SQ3370, including determination of the maximum tolerated dose and the recommended Phase 2 dose. [ Time Frame: 35 Days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106492


Contacts
Layout table for location contacts
Contact: Shasqi Clinical Operations 415-800-1376 clinicalstudies@shasqi.com

Locations
Layout table for location information
United States, California
Stanford Cancer Center Recruiting
Palo Alto, California, United States, 94304
Contact: Principal Investigator    415-800-1376    clinicalstudies@shasqi.com   
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Principal Investigator    415-800-1376    clinicalstudies@shasqi.com   
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75251
Contact: Principal Investigator    415-800-1376    clinicalstudies@shasqi.com   
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Vivek Subbiah, MD    713-563-0393    VSubbiah@mdanderson.org   
Australia, New South Wales
Chris O'Brien Lifehouse Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Principal Investigator    415-800-1376    clinicalstudies@shasqi.com   
Royal North Shore Hospital Recruiting
Sydney, New South Wales, Australia, 2065
Contact: Principal Investigator    415-800-1376    clinicalstudies@shasqi.com   
Sponsors and Collaborators
Shasqi, Inc.
Layout table for additonal information
Responsible Party: Shasqi, Inc.
ClinicalTrials.gov Identifier: NCT04106492    
Other Study ID Numbers: SQ3370-001
2020-0185 ( Other Identifier: MD Anderson Cancer Center )
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shasqi, Inc.:
Sarcoma
Cancer
Tumor
Soft Tissue Sarcoma
Solid Tumor
Doxorubicin
Intratumoral
Anthracycline
Phase 1
Lung Cancer
Breast Cancer
Ovarian Cancer
Pancreatic Cancer
Esophageal Cancer
Precision Oncology
Precision Chemotherapy
Local Cancer Therapy
Targeted Cancer Therapy
Bladder Cancer
Gastric Tumor
Skin Cancer
Melanoma