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

A Multicenter Phase 1/2a, Open-Label Study of SQ3370 in Patients With Advanced Solid Tumors

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04106492
Enrollment
53
Registered
2019-09-27
Start date
2020-08-01
Completion date
2023-09-07
Last updated
2025-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief summary

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

Interventions

DRUGSQ3370

SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin

Sponsors

Shasqi, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Phase 1 CohortsFrom start of treatment to approximately 12 weeksTo determine the Recommended Phase 2 Dose of SQ3370

Secondary

MeasureTime frameDescription
Phase 2a: Objective Response Rate (ORR)Up to 1 yearPer 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.

Countries

Australia, United States

Participant flow

Participants by arm

ArmCount
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
1
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
1
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
1
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
3
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
3
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
4
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
4
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
7
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
6
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
5
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
3
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
1
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
2
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
6
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
6
Total53

Baseline characteristics

CharacteristicDose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33)Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33)TotalP2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days)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)Phase 2a Expansion Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33)Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33)Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33)Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33)Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33)Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33)Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33)Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33)Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33)Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33)Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33)
Age, Continuous70 years66 years58 years57 years64 years45 years84 years53 years63 years62 years65 years63.5 years44.5 years68 years65 years47 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants10 Participants1 Participants0 Participants2 Participants0 Participants0 Participants2 Participants0 Participants3 Participants1 Participants1 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants1 Participants43 Participants5 Participants6 Participants0 Participants1 Participants3 Participants3 Participants6 Participants4 Participants3 Participants3 Participants3 Participants3 Participants1 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Prior exposure to anthracyclines1 Participants0 Participants19 Participants0 Participants0 Participants0 Participants0 Participants3 Participants4 Participants1 Participants3 Participants2 Participants1 Participants2 Participants2 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants6 Participants0 Participants2 Participants0 Participants0 Participants0 Participants1 Participants1 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants2 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
White
1 Participants1 Participants45 Participants5 Participants4 Participants2 Participants1 Participants3 Participants4 Participants5 Participants6 Participants4 Participants4 Participants1 Participants3 Participants1 Participants
Region of Enrollment
Australia
1 participants0 participants11 participants1 participants0 participants0 participants0 participants0 participants0 participants1 participants1 participants1 participants2 participants2 participants2 participants0 participants
Region of Enrollment
United States
0 participants1 participants42 participants5 participants6 participants2 participants1 participants3 participants5 participants5 participants6 participants3 participants2 participants1 participants1 participants1 participants
Sex: Female, Male
Female
0 Participants0 Participants27 Participants2 Participants2 Participants1 Participants1 Participants0 Participants4 Participants4 Participants4 Participants3 Participants3 Participants1 Participants1 Participants1 Participants
Sex: Female, Male
Male
1 Participants1 Participants26 Participants4 Participants4 Participants1 Participants0 Participants3 Participants1 Participants2 Participants3 Participants1 Participants1 Participants2 Participants2 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
EG012
affected / at risk
EG013
affected / at risk
EG014
affected / at risk
deaths
Total, all-cause mortality
1 / 10 / 10 / 10 / 30 / 30 / 40 / 40 / 70 / 60 / 50 / 30 / 10 / 21 / 60 / 6
other
Total, other adverse events
1 / 11 / 11 / 13 / 33 / 34 / 44 / 47 / 76 / 65 / 53 / 31 / 12 / 26 / 66 / 6
serious
Total, serious adverse events
1 / 10 / 11 / 12 / 32 / 30 / 42 / 42 / 70 / 61 / 51 / 30 / 10 / 22 / 61 / 6

Outcome results

Primary

Phase 1 Cohorts

To determine the Recommended Phase 2 Dose of SQ3370

Time frame: From start of treatment to approximately 12 weeks

Population: Dose escalation participants

ArmMeasureValue (NUMBER)
Dose Escalation Cohort (10 mL SQL70)Phase 1 Cohorts1250 mg/m2 per cycle
Dose Escalation Cohort (20 mL SQL70)Phase 1 Cohorts1250 mg/m2 per cycle
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.

Time frame: Up to 1 year

ArmMeasureValue (NUMBER)
Dose Escalation Cohort (10 mL SQL70)Phase 2a: Objective Response Rate (ORR)0 participants with an objective response
Dose Escalation Cohort (20 mL SQL70)Phase 2a: Objective Response Rate (ORR)1 participants with an objective response
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)Phase 2a: Objective Response Rate (ORR)0 participants with an objective response
P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days)Phase 2a: Objective Response Rate (ORR)1 participants with an objective response

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026