Evaluating SQ3370 for advanced solid tumors

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

This study is testing a new treatment called SQ3370 to see if it is safe and effective for people with advanced solid tumors, especially those who haven't had certain chemotherapy before.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 145 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shasqi, Inc. (Industry-sponsored)
• Drugs / interventions: Trastuzumab, Chemotherapy, immunotherapy, radiation
• Locations: 10 sites (Duarte, California and 9 other locations)
• Trial ID: NCT04106492 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, and preliminary effectiveness of SQ3370 in patients diagnosed with advanced solid tumors, particularly soft tissue sarcomas. It is designed as a Phase 1/2a interventional trial, focusing on patients who have not previously received certain chemotherapy treatments. Participants will be monitored for their response to the treatment and any side effects experienced during the trial.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced soft tissue sarcoma or other solid tumors who meet specific health criteria.

Not a fit: Patients who have previously received high doses of certain chemotherapy agents or have significant cardiac issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: Other studies have shown promise with similar approaches in treating advanced solid tumors, but this specific treatment is being evaluated for the first time.

Eligibility criteria

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

Where this trial is running

Duarte, California and 9 other locations

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

Study contacts

• Study coordinator: Shasqi Clinical Operations

Conditions Cancer; Sarcoma; Tumor; Soft Tissue Sarcoma; Solid Tumor; Doxorubicin; Intratumoral; Anthracycline