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NCT04106492 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2025-11-14

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Phase 1 Cohorts

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outcome · POSTED

Phase 2a: Objective Response Rate (ORR)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 8 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    intervention Names
    1. Drug: SQ3370
    label
    Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33)
    type
    EXPERIMENTAL
  2. description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 16 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors.
    intervention Names
    1. Drug: SQ3370
    label
    Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33)
    type
    EXPERIMENTAL
  3. description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 32 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors.
    intervention Names
    1. Drug: SQ3370
    label
    Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33)
    type
    EXPERIMENTAL
  4. description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 58 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors.
    intervention Names
    1. Drug: SQ3370
    label
    Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33)
    type
    EXPERIMENTAL
  5. description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    intervention Names
    1. Drug: SQ3370
    label
    Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33)
    type
    EXPERIMENTAL
  6. description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    intervention Names
    1. Drug: SQ3370
    label
    Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33)
    type
    EXPERIMENTAL
  7. description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    intervention Names
    1. Drug: SQ3370
    label
    Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33)
    type
    EXPERIMENTAL
  8. description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    intervention Names
    1. Drug: SQ3370
    label
    Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33)
    type
    EXPERIMENTAL
  9. description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 315 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    intervention Names
    1. Drug: SQ3370
    label
    Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33)
    type
    EXPERIMENTAL
  10. description
    20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    intervention Names
    1. Drug: SQ3370
    label
    Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33)
    type
    EXPERIMENTAL
  11. description
    20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    intervention Names
    1. Drug: SQ3370
    label
    Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33)
    type
    EXPERIMENTAL
  12. description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    intervention Names
    1. Drug: SQ3370
    label
    Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33)
    2. Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33)
    3. Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33)
    4. Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33)
    5. Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33)
    6. Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33)
    7. Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33)
    8. Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33)
    9. Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33)
    10. Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33)
    11. Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33)
    12. Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33)
    description
    SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin
    name
    SQ3370
    type
    DRUG
Study design
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.
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
53
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    To determine the Recommended Phase 2 Dose of SQ3370
    measure
    Phase 1 Cohorts
    time Frame
    From start of treatment to approximately 12 weeks
secondary Outcomes
  1. description
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
    measure
    Phase 2a: Objective Response Rate (ORR)
    time Frame
    Up to 1 year
Full study description
brief Summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of SQ3370 in patients with advanced solid tumors.
Source references
references
  1. citation
    Srinivasan S, Yee NA, Aleckovic M, Zakharian M, Mahmoodi A, Wagner S, Nguyen TH, Chawla SP, Guminski AD, Mejia Oneto JM. Development of a First-in-Class Click Chemistry-Based Cancer Therapeutic, from Preclinical Evaluation to a First-in-Human Dose Escalation Clinical Trial. Clin Cancer Res. 2025 Sep 2;31(17):3662-3677. doi: 10.1158/1078-0432.CCR-24-2539.
    pmid
    40522144
    type
    DERIVED
  2. citation
    Srinivasan S, Yee NA, Zakharian M, Aleckovic M, Mahmoodi A, Nguyen TH, Mejia Oneto JM. SQ3370, the first clinical click chemistry-activated cancer therapeutic, shows safety in humans and translatability across species. bioRxiv [Preprint]. 2023 Mar 29:2023.03.28.534654. doi: 10.1101/2023.03.28.534654.
    pmid
    37034617
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      occurrences
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        exact text
        NCT04106492
        start
        0
      offset unit
      unicode_code_points
      query cond
      Uterine Sarcoma
      query disease state id
      ds-uterine-sarcoma
      source file
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      source file sha256
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      source string sha256
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    Preserved source evidence · Not medical advice