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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04106492
Ethics application status
Date submitted
25/09/2019
Date registered
27/09/2019

Titles & IDs
Public title
Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors
Scientific title
A Multicenter Phase 1/2a, 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: Dose Escalation Cohort (10 mL SQL70) - Participants will receive 10 mL of SQL70 biopolymer injected intratumorally on Day 1 of each 21-day cycle into a single lesion and then receive escalating doses of SQP33 protodrug administered IV from Day 1 through Day 5 (5 doses) of each 21-day cycle.

Experimental: Dose Escalation Cohort (20 mL SQL70) - Participants will receive 20 mL of SQL70 biopolymer injected intratumorally on Day 1 of each 21-day cycle into a single lesion and then receive escalating doses of SQP33 protodrug administered IV from Day 1 through Day 5 (5 doses) of each 21-day cycle.

Experimental: Cohort A - Participants will receive SQL70 biopolymer injected intratumorally on Day 1 of each 21-day cycle into a single lesion as determined in Dose Escalation. Then will receive a lower dose than RP2D of SQP33 protodrug administered IV from Day 1 through Day 5 (5 doses) of each 21-day cycle.

Experimental: Phase 2a Expansion Group 1 (Extremity STS) - Participants with soft tissue sarcomas of the extremity AJCC Stage III OR IV (\>5 cm injectable tumors locally advanced and or metastatic, not amendable to primary surgical intervention and who are anthracycline naïve.

Experimental: Phase 2a Expansion Group 2 (Unresectable STS) - Locally advanced, unresectable or metastatic, soft tissue sarcomas who are anthracycline naïve.

Experimental: Phase 2a Expansion Group 3a (Head and Neck) - Participants with histologically or cytologically confirmed relapsed or metastatic squamous-cell carcinoma of the head and neck, who have exhausted curative intent therapies or patients with distant metastases who may have received one or less chemotherapy regimen.


Treatment: Drugs: SQ3370
SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1 Cohorts
Timepoint [1] 0 0
From start of treatment to approximately 12 weeks
Primary outcome [2] 0 0
Phase 2a Expansion Groups
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Phase 1: Pharmacokinetics (PK)
Timepoint [1] 0 0
From start of treatment to approximately 12 weeks
Secondary outcome [2] 0 0
Phase 1: Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Phase 1: Duration of Response (DOR)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Phase 2a: Objective Response Rate (ORR)
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Phase 2a: Duration of Response (DOR)
Timepoint [5] 0 0
Up to 2 years
Secondary outcome [6] 0 0
Phase 2a: Overall Survival
Timepoint [6] 0 0
Up to 2 years
Secondary outcome [7] 0 0
Phase 2a: Pharmacokinetics
Timepoint [7] 0 0
From start of treatment to approximately 12 weeks

Eligibility
Key inclusion criteria
Phase 1:

1. Diagnosis of advanced soft tissue sarcoma or other solid tumors
2. Adequate hematologic, hepatic, renal, and coagulation function
3. ECOG performance status score 0-1
4. Tumor is the type where published clinical data would suggest that anthracyclines have cytotoxic activity
5. Injectable tumor present

Phase 1:
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior exposure to 300 mg/m^2 of Dox HCl or DOXIL / CAELYX ® or 600 mg/m^2 of Epirubicin HCl
2. Congestive heart failure (CHF), severe myocardial insufficiency, or cardiac arrhythmia
3. 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)
4. Trastuzumab or trastuzumab emtansine dosed within 7 months prior to Cycle 1 Day 1.
5. Any transfusion within 14 days prior to Cycle 1 Day 1.
6. Pregnant or breast-feeding women.
7. Known active CNS metastases and/or carcinomatous meningitis or symptomatic brain metastasis. Participants with previously treated brain metastases may participate provided they are radiologically stable
8. History of allergic reactions attributed to Dox or other anthracyclines, NaHA, hyaluronic acid, or gram-positive bacterial proteins
9. History or evidence of clinically unstable/uncontrolled disorder, condition, or disease

Phase 2a Expansion Group 1 (Extremity STS): Inclusion

1. Patients with unresectable soft tissue sarcomas of the extremity AJCC Stage III OR select IV (=>5 cm injectable tumors) locally advanced and or metastatic, not amendable to primary surgical intervention according to the consensus of a multidisciplinary treatment team, determined prior to screening.
2. High grade STS, Grade 2/3, with an assessable/injectable lesion of at least diameter =5 cm by RECIST 1.1 criteria
3. No prior chemotherapy for STS, or radiation to affected limb

Phase 2a Expansion Group 1 (Extremity STS): Exclusion

1. Uncontrolled pain related to tumor
2. Open wounds or tissue necrosis related to tumor mass
3. Compartment syndrome or impending compartment syndrome

Phase 2a Expansion Group 2 (Unresectable STS): Inclusion

1. Locally advanced or metastatic, unresectable, soft-tissue sarcoma of intermediate or high grade with measurable disease.
2. Life expectancy >12 weeks (about 3 month)

Phase 2a Expansion Group 2 (Unresectable STS): Exclusion

1. Prior exposure to anthracyclines
2. Treatment naive extremity tumors

Phase 2a Expansion Group 3a (Head and Neck): Inclusion

1. Patients with histologically or cytologically confirmed squamous-cell carcinoma of the head and neck (HNSCC) who meet any of the following a) confirmed relapsed HNSCC or b) metastatic at initial presentation HNSCC
2. Patients who may have received two or less systemic regimens (therapies include chemotherapy and/or immunotherapy)

Phase 2a Expansion Group 3a (Head and Neck): Exclusion

1. Airway obstruction by tumor mass that requires clinical intervention
2. Prior treatment with anthracyclines

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
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
1/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/07/2026
Actual
Sample size
Target
145
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [3] 0 0
Cancer Research Institute - Adelaide
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
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
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
Oregon
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jim Williams, MD
Address 0 0
Shasqi, Inc.
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04106492