Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors

Cancer Clinical Trial

Official title:

A Multicenter Phase 1/2a, Open-Label Study of SQ3370 in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04106492
• Other study ID #: SQ3370-001
• Secondary ID: 2020-0185
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 1, 2020
• Est. completion date: July 9, 2026

Study information

• Verified date: February 2023
• Source: Shasqi, Inc.
• Contact: Shasqi Clinical Operations
• Phone: 415-800-1376
• Email: clinicalstudies[@]shasqi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of SQ3370 in patients with advanced solid tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: July 9, 2026
• Est. primary completion date: August 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Phase 1: Inclusion Criteria:

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: 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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• SQ3370
SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin

Locations

Country	Name	City	State
Australia	Cancer Research Institute	Adelaide	South Australia
Australia	Chris O'Brien Lifehouse	Camperdown	New South Wales
Australia	Royal North Shore Hospital	Sydney	New South Wales
United States	City of Hope	Duarte	California
United States	MD Anderson Cancer Center	Houston	Texas
United States	Stanford Cancer Center	Palo Alto	California
United States	Oregon Health & Science University	Portland	Oregon
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	Sarcoma Oncology Center	Santa Monica	California
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Shasqi, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate level of SQP33 in tumor	To determine the level of SQP33 protodrug and active Doxorubicin in tumor tissue	From start of treatment to approximately 12 weeks
Other	Evaluate Pharmacodynamics (PD)	To assess immune response (changes in immune biomarkers) as assessed by PBMCs	From start of treatment to approximately 12 weeks
Primary	Phase 1 Cohorts	To determine the Maximum Tolerated Dose, if possible, and/or Recommended Phase 2 Dose of SQ3370	From start of treatment to approximately 12 weeks
Primary	Phase 2a Expansion Groups	To evaluate safety. Defined as type, frequency, severity, timing of onset, duration, and relationship to study drugs of any treatment-emergent adverse events (TEAEs); laboratory abnormalities; vital sign abnormalities; adverse electrocardiogram (ECG) or, ECH/MUGA findings; SAEs; or AEs leading to interruption, modification, or discontinuation of study treatment	Up to 2 years
Secondary	Phase 1: Pharmacokinetics (PK)	To determine Maximum Plasma concentration (Cmax) for SQP33 protodrug and active Dox following SQ3370 treatment	From start of treatment to approximately 12 weeks
Secondary	Phase 1: Objective Response Rate (ORR)	Defined as achievement of complete response (CR) or partial response (PR) by RECIST v1.1	Up to 2 years
Secondary	Phase 1: Duration of Response (DOR)	Defined as the interval from the first documentation of objective response to the earlier of the first documentation of disease progression or death from any cause	Up to 2 years
Secondary	Phase 2a: Objective Response Rate (ORR)	Defined as achievement of complete response (CR) or partial response (PR) by RECIST v1.1	Up to 2 years
Secondary	Phase 2a: Duration of Response (DOR)	Defined as the interval from the first documentation of objective response to the earlier of the first documentation of disease progression or death from any cause	Up to 2 years
Secondary	Phase 2a: Overall Survival	Defined as the time between the date of enrollment to the date of death from any cause.	Up to 2 years
Secondary	Phase 2a: Pharmacokinetics	Determine plasma concentration and PK parameters for SQP33 protodrug and active Dox following SQ3370 treatment	From start of treatment to approximately 12 weeks