Clinical trial NCT04106492: Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors
Official title: A Multicenter Phase 1/2a, Open-Label Study of SQ3370 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cancer
Keywords: Sarcoma
Cancer
Tumor
Soft Tissue Sarcoma
Solid Tumor
Doxorubicin
Intratumoral
Anthracycline
Phase 1
Ovarian Cancer
Precision Oncology
Precision Chemotherapy
Local Cancer Therapy
Targeted Cancer Therapy
Uterine Cancer
Head and Neck Cancer
Lung Cancer
Lead sponsor: Shasqi, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-27
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 1 dose escalation part of the study was done sequentially. The Phase 2 part of the study will be done in parallel between the four groups.
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Phase 1 Cohorts
timeFrame: From start of treatment to approximately 12 weeks
measure: Phase 2a Expansion Groups
timeFrame: Up to 2 years
Secondary outcomes:
measure: Phase 1: Pharmacokinetics (PK)
timeFrame: From start of treatment to approximately 12 weeks
measure: Phase 1: Objective Response Rate (ORR)
timeFrame: Up to 2 years
measure: Phase 1: Duration of Response (DOR)
timeFrame: Up to 2 years
measure: Phase 2a: Objective Response Rate (ORR)
timeFrame: Up to 2 years
measure: Phase 2a: Duration of Response (DOR)
timeFrame: Up to 2 years
measure: Phase 2a: Overall Survival
timeFrame: Up to 2 years
measure: Phase 2a: Pharmacokinetics
timeFrame: From start of treatment to approximately 12 weeks
Other outcomes:
measure: Evaluate level of SQP33 in tumor
timeFrame: From start of treatment to approximately 12 weeks
measure: Evaluate Pharmacodynamics (PD)
timeFrame: From start of treatment to approximately 12 weeks
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Center
state: California
city: Santa Monica
country: United States
facility: Sarcoma Oncology Center
state: California
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Sydney
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Cancer Research Institute
state: South Australia
Study officials:
affiliation: Shasqi, Inc.
name: Jim Williams, MD
role: STUDY_DIRECTOR
References: