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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04106492




Registration number
NCT04106492
Ethics application status
Date submitted
25/09/2019
Date registered
27/09/2019
Date last updated
23/09/2020

Titles & IDs
Public title
Phase 1 Study of SQ3370 in Patients With Advanced Solid Tumors
Scientific title
A Multicenter Phase 1, Open-Label Study of SQ3370 in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
2020-0185
Secondary ID [2] 0 0
SQ3370-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SQ3370

Experimental: SQ3370 -


Treatment: Drugs: SQ3370
SQ3370 consists of 2 components: SQL70, a prodrug-activating biomaterial and SQP33, a prodrug of Doxorubicin

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of SQ3370, including determination of the maximum tolerated dose and the recommended Phase 2 dose.
Timepoint [1] 0 0
35 Days

Eligibility
Key inclusion criteria
- Diagnosis of an advanced local or metastatic solid tumor

- Adequate hematologic, hepatic, renal, and coagulation function
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior exposure to 225 mg/m2 of Dox HCl or DOXIL / CAELYX ® or 450 mg/m2 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

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Shasqi, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy
of SQ3370 in patients with cancer (solid tumors).
Trial website
https://clinicaltrials.gov/show/NCT04106492
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shasqi Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
415-800-1376
Fax 0 0
Email 0 0
clinicalstudies@shasqi.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04106492