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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-0185 | Other Identifier | MD Anderson Cancer Center |
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Sponsor's decision
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The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of SQ3370 in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33) | Experimental | 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 |
|
| Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33) | Experimental | 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. |
|
| Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33) | Experimental | 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. |
|
| Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33) | Experimental | 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. |
|
| Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SQ3370 | Drug | SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 Cohorts | To determine the Recommended Phase 2 Dose of SQ3370 | From start of treatment to approximately 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2a: Objective Response Rate (ORR) | 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. | Up to 1 year |
Not provided
Phase 1: Inclusion Criteria:
Phase 1: Exclusion Criteria:
Prior exposure to 300 mg/m^2 of Dox HCl or DOXIL / CAELYX ® or 600 mg/m^2 of Epirubicin HCl
Congestive heart failure (CHF), severe myocardial insufficiency, or cardiac arrhythmia
Any of the following within 28 days prior to Cycle 1 Day 1:
Trastuzumab or trastuzumab emtansine dosed within 7 months prior to Cycle 1 Day 1.
Any transfusion within 14 days prior to Cycle 1 Day 1.
Pregnant or breast-feeding women.
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
History of allergic reactions attributed to Dox or other anthracyclines, NaHA, hyaluronic acid, or gram-positive bacterial proteins
History or evidence of clinically unstable/uncontrolled disorder, condition, or disease
Phase 2a Expansion Group 1 (Extremity STS): Inclusion
Phase 2a Expansion Group 1 (Extremity STS): Exclusion
Phase 2a Expansion Group 2 (Unresectable STS): Inclusion
Phase 2a Expansion Group 2 (Unresectable STS): Exclusion
Phase 2a Expansion Group 3a (Head and Neck): Inclusion
Phase 2a Expansion Group 3a (Head and Neck): Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Jim Williams, MD | Shasqi, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Stanford Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40522144 | Derived | 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. | |
| 37034617 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33) | 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 |
| FG001 | Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33) | 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 |
| FG002 | Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33) | 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 |
| FG003 | Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33) | 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 |
| FG004 | Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33) | 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 |
| FG005 | Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33) | 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 |
| FG006 | Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33) | 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 |
| FG007 | Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33) | 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 |
| FG008 | Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33) | 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 |
| FG009 | Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33) | 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 |
| FG010 | Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33) | 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 |
| FG011 | Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33) | 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 |
| FG012 | Phase 2a Expansion Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33) | 20 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 soft tissue sarcomas of the extremity |
| FG013 | P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day) | 10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 500 mg/m^2 of SQP33 infused on Day 1 and 2 with 250 mg/m^2 of SQP33 infused on each Day 3 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve |
| FG014 | P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days) | 10 mL of SQL70 injected intratumorally on Day with 250 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33) | 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 |
| BG001 | Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1 Cohorts | To determine the Recommended Phase 2 Dose of SQ3370 | Dose escalation participants | Posted | Number | mg/m2 per cycle | From start of treatment to approximately 12 weeks |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33) | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose M. Mejia Oneto, MD, PhD | Shasqi Inc | 415-800-1376 | clinicalstudies@shasqi.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2022 | Mar 27, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2023 | Mar 27, 2024 | SAP_001.pdf |
Not provided
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D010051 | Ovarian Neoplasms |
| D014594 | Uterine Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
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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.
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| Experimental |
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 |
|
| Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33) | Experimental | 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 |
|
| Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33) | Experimental | 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 |
|
| Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33) | Experimental | 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 |
|
| Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33) | Experimental | 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 |
|
| Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33) | Experimental | 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 |
|
| Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33) | Experimental | 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 |
|
| Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33) | Experimental | 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 |
|
| P2a Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33) | Experimental | 20 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 soft tissue sarcomas of the extremity |
|
| P2a Group 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 days and and 250 mg/m^2/ of SQP33 for 1 day) | Experimental | 10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 500 mg/m^2 of SQP33 infused on Day 1 and 2 with 250 mg/m^2 of SQP33 infused on each Day 3 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve |
|
| P2a Group 2 (10 mL SQL70 and 250 mg/m^2/day of SQP33 for five days) | Experimental | 10 mL of SQL70 injected intratumorally on Day with 250 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve |
|
| 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 |
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| Royal North Shore Hospital | Sydney | New South Wales | 2065 | Australia |
| Cancer Research Institute | Adelaide | South Australia | 5000 | Australia |
| 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. |
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 |
| BG002 | Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33) | 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 |
| BG003 | Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33) | 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 |
| BG004 | Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33) | 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 |
| BG005 | Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33) | 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 |
| BG006 | Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33) | 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 |
| BG007 | Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33) | 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 |
| BG008 | Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33) | 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 |
| BG009 | Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33) | 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 |
| BG010 | Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33) | 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 |
| BG011 | Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33) | 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 |
| BG012 | Phase 2a Expansion Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33) | 20 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 soft tissue sarcomas of the extremity |
| BG013 | P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day) | 10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 500 mg/m^2 of SQP33 infused on Day 1 and 2 with 250 mg/m^2 of SQP33 infused on each Day 3 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve |
| BG014 | P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days) | 10 mL of SQL70 injected intratumorally on Day with 250 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve |
| BG015 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Prior exposure to anthracyclines | Count of Participants | Participants | No |
|
Participants will receive 20 mL of SQL70 biopolymer injected intratumorally on Day 1 of each 21-day cycle into a single lesion and then receive escalating doses of SQP33 protodrug administered IV from Day 1 through Day 5 (5 doses) of each 21-day cycle.
SQ3370: SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin
|
|
| Secondary | Phase 2a: Objective Response Rate (ORR) | 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. | Posted | Number | participants with an objective response | Up to 1 year |
|
|
|
| 1 |
| 1 |
| 1 |
| 1 |
| 1 |
| 1 |
| EG001 | Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33) | 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 | 0 | 1 | 0 | 1 | 1 | 1 |
| EG002 | Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33) | 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 | 0 | 1 | 1 | 1 | 1 | 1 |
| EG003 | Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33) | 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 | 0 | 3 | 2 | 3 | 3 | 3 |
| EG004 | Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33) | 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 | 0 | 3 | 2 | 3 | 3 | 3 |
| EG005 | Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33) | 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 | 0 | 4 | 0 | 4 | 4 | 4 |
| EG006 | Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33) | 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 | 0 | 4 | 2 | 4 | 4 | 4 |
| EG007 | Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33) | 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 | 0 | 7 | 2 | 7 | 7 | 7 |
| EG008 | Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33) | 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 | 0 | 6 | 0 | 6 | 6 | 6 |
| EG009 | Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33) | 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 | 0 | 5 | 1 | 5 | 5 | 5 |
| EG010 | Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33) | 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 | 0 | 3 | 1 | 3 | 3 | 3 |
| EG011 | Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33) | 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 | 0 | 1 | 0 | 1 | 1 | 1 |
| EG012 | Phase 2a Expansion Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33) | 20 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 soft tissue sarcomas of the extremity | 0 | 2 | 0 | 2 | 2 | 2 |
| EG013 | P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day) | 10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 500 mg/m^2 of SQP33 infused on Day 1 and 2 with 250 mg/m^2 of SQP33 infused on each Day 3 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve | 1 | 6 | 2 | 6 | 6 | 6 |
| EG014 | P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days) | 10 mL of SQL70 injected intratumorally on Day with 250 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve | 0 | 6 | 1 | 6 | 6 | 6 |
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Pelvic venous thrombosis | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Troponin T increased | Investigations | MedDRA (24.1) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Prohormone brain natriuretic peptide increased | Investigations | MedDRA (24.1) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Colonic Fistula | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Lip Pain | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Umbilical Hernia | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Catheter Site Erythema | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Face Oedema | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| General Physical Health Deterioration | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Impaired Healing | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Injection Site Bruising | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Medical Device Site Pain | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Peripheral Swelling | General disorders | MedDRA (24.1) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Bicytopenia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
|
| Iron Deficiency | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Candida Infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Device Related Infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Lymphangitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Medical Device Site Infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Respiratory Tract Infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Skin Infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Vascular Access Site Infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Vulvovaginal Mycotic Infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Nasal Dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
|
| Breast Pain | Reproductive system and breast disorders | MedDRA (24.1) | Systematic Assessment |
|
| Pelvic Pain | Reproductive system and breast disorders | MedDRA (24.1) | Systematic Assessment |
|
| Inappropriate Antidiuretic Hormone Secretion | Endocrine disorders | MedDRA (24.1) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (24.1) | Systematic Assessment |
|
| Blindness Transient | Eye disorders | MedDRA (24.1) | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA (24.1) | Systematic Assessment |
|
| Dry Eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
|
| Bladder Spasm | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
|
| Urge Incontinence | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Intervertebral Disc Displacement | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Pain In Jaw | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Rash Macular | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Haemorrhagic Transformation Stroke | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
|
| Pelvic Venous Thrombosis | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
|
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
|
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
|
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
|
| Vascular Access Site Erythema | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
|
| Vascular Access Site Haematoma | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
|
| Limb Injury | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
|
| Post Procedural Discharge | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
|
| Vascular Access Site Pain | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
|
Not provided
Not provided
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014591 | Uterine Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |