TERMINATED

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

Conditions

Cancer Sarcoma 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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the safety, tolerability, and preliminary activity 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

Quick Facts

Study Start:2020-08-01

Study Completion:2023-09-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT04106492

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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 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 1. Uncontrolled pain related to tumor 2. Open wounds or tissue necrosis related to tumor mass 3. Compartment syndrome or impending compartment syndrome 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) 1. Prior exposure to anthracyclines 2. Treatment naive extremity tumors 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) 1. Airway obstruction by tumor mass that requires clinical intervention 2. Prior treatment with anthracyclines

Inclusion Criteria

Exclusion 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

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
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
1. Uncontrolled pain related to tumor
2. Open wounds or tissue necrosis related to tumor mass
3. Compartment syndrome or impending compartment syndrome
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)
1. Prior exposure to anthracyclines
2. Treatment naive extremity tumors
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)
1. Airway obstruction by tumor mass that requires clinical intervention
2. Prior treatment with anthracyclines

Contacts and Locations

Principal Investigator

Jim Williams, MD

STUDY_DIRECTOR

Shasqi, Inc.

Study Locations (Sites)

City of Hope

Duarte, California, 91010

United States

Stanford Cancer Center

Palo Alto, California, 94304

United States

Sarcoma Oncology Center

Santa Monica, California, 90403

United States

Washington University in St. Louis

St Louis, Missouri, 63110

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

University of Washington

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: Shasqi, Inc.

Jim Williams, MD, STUDY_DIRECTOR, Shasqi, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-01

Study Completion Date2023-09-07

Study Record Updates

Study Start Date2020-08-01

Study Completion Date2023-09-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Cancer