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

Trial ID or NCT#

NCT04106492

Status

recruiting iconRECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Diagnosis of advanced soft tissue sarcoma or other solid tumors2. Adequate hematologic, hepatic, renal, and coagulation function3. ECOG performance status score 0-14. Tumor is the type where published clinical data would suggest that anthracyclines have cytotoxic activity5. Injectable tumor present
    1. Phase 1:
Exclusion Criteria:
  1. 1. Prior exposure to 300 mg/m\^2 of Dox HCl or DOXIL / CAELYX ® or 600 mg/m\^2 of Epirubicin HCl2. Congestive heart failure (CHF), severe myocardial insufficiency, or cardiac arrhythmia3. Any of the following within 28 days prior to Cycle 1 Day 1:
    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 stable8. History of allergic reactions attributed to Dox or other anthracyclines, NaHA, hyaluronic acid, or gram-positive bacterial proteins9. History or evidence of clinically unstable/uncontrolled disorder, condition, or disease
      1. Phase 2a Expansion Group 1 (Extremity STS): Inclusion
  2. 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 criteria3. No prior chemotherapy for STS, or radiation to affected limb
    1. Phase 2a Expansion Group 1 (Extremity STS): Exclusion
  • 1. Uncontrolled pain related to tumor2. Open wounds or tissue necrosis related to tumor mass3. Compartment syndrome or impending compartment syndrome
    1. 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)
    1. Phase 2a Expansion Group 2 (Unresectable STS): Exclusion
  • 1. Prior exposure to anthracyclines2. Treatment naive extremity tumors
    1. 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 HNSCC2. Patients who may have received two or less systemic regimens (therapies include chemotherapy and/or immunotherapy)
    1. Phase 2a Expansion Group 3a (Head and Neck): Exclusion
  • 1. Airway obstruction by tumor mass that requires clinical intervention2. Prior treatment with anthracyclines
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    Investigator(s)

    Nam Quoc Bui
    Nam Quoc Bui
    Medical oncologist, Sarcoma specialist
    Clinical Assistant Professor, Medicine - Oncology
    Robert Steffner
    Robert Steffner
    Orthopaedic surgical oncologist, Orthopaedic surgical oncologist
    Clinical Associate Professor, Orthopaedic Surgery
    Michelle Y. Williams PhD, RN, FAAN

    Contact us to find out if this trial is right for you.

    Contact

    Amir Emami
    650-498-0623

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    View on ClinicalTrials.gov