Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT04106492 |
Recruitment Status :
Recruiting
First Posted : September 27, 2019
Last Update Posted : February 9, 2023
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Condition or disease | Intervention/treatment | Phase |
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Cancer | Drug: SQ3370 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 145 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
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: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter Phase 1/2a, Open-Label Study of SQ3370 in Patients With Advanced Solid Tumors |
Actual Study Start Date : | August 1, 2020 |
Estimated Primary Completion Date : | August 7, 2024 |
Estimated Study Completion Date : | July 9, 2026 |
Arm | Intervention/treatment |
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Experimental: Dose Escalation Cohort (10 mL SQL70)
Participants will receive 10 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.
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Drug: SQ3370
SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin |
Experimental: Dose Escalation Cohort (20 mL SQL70)
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.
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Drug: SQ3370
SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin |
Experimental: Cohort A
Participants will receive SQL70 biopolymer injected intratumorally on Day 1 of each 21-day cycle into a single lesion as determined in Dose Escalation. Then will receive a lower dose than RP2D of SQP33 protodrug administered IV from Day 1 through Day 5 (5 doses) of each 21-day cycle.
|
Drug: SQ3370
SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin |
Experimental: Phase 2a Expansion Group 1 (Extremity STS)
Participants with soft tissue sarcomas of the extremity AJCC Stage III OR IV (>5 cm injectable tumors locally advanced and or metastatic, not amendable to primary surgical intervention and who are anthracycline naïve.
|
Drug: SQ3370
SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin |
Experimental: Phase 2a Expansion Group 2 (Unresectable STS)
Locally advanced, unresectable or metastatic, soft tissue sarcomas who are anthracycline naïve.
|
Drug: SQ3370
SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin |
Experimental: Phase 2a Expansion Group 3a (Head and Neck)
Participants with histologically or cytologically confirmed relapsed or metastatic squamous-cell carcinoma of the head and neck, who have exhausted curative intent therapies or patients with distant metastases who may have received one or less chemotherapy regimen.
|
Drug: SQ3370
SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin |
- Phase 1 Cohorts [ Time Frame: From start of treatment to approximately 12 weeks ]To determine the Maximum Tolerated Dose, if possible, and/or Recommended Phase 2 Dose of SQ3370
- Phase 2a Expansion Groups [ Time Frame: Up to 2 years ]To evaluate safety. Defined as type, frequency, severity, timing of onset, duration, and relationship to study drugs of any treatment-emergent adverse events (TEAEs); laboratory abnormalities; vital sign abnormalities; adverse electrocardiogram (ECG) or, ECH/MUGA findings; SAEs; or AEs leading to interruption, modification, or discontinuation of study treatment
- Phase 1: Pharmacokinetics (PK) [ Time Frame: From start of treatment to approximately 12 weeks ]To determine Maximum Plasma concentration (Cmax) for SQP33 protodrug and active Dox following SQ3370 treatment
- Phase 1: Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]Defined as achievement of complete response (CR) or partial response (PR) by RECIST v1.1
- Phase 1: Duration of Response (DOR) [ Time Frame: Up to 2 years ]Defined as the interval from the first documentation of objective response to the earlier of the first documentation of disease progression or death from any cause
- Phase 2a: Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]Defined as achievement of complete response (CR) or partial response (PR) by RECIST v1.1
- Phase 2a: Duration of Response (DOR) [ Time Frame: Up to 2 years ]Defined as the interval from the first documentation of objective response to the earlier of the first documentation of disease progression or death from any cause
- Phase 2a: Overall Survival [ Time Frame: Up to 2 years ]Defined as the time between the date of enrollment to the date of death from any cause.
- Phase 2a: Pharmacokinetics [ Time Frame: From start of treatment to approximately 12 weeks ]Determine plasma concentration and PK parameters for SQP33 protodrug and active Dox following SQ3370 treatment
- Evaluate level of SQP33 in tumor [ Time Frame: From start of treatment to approximately 12 weeks ]To determine the level of SQP33 protodrug and active Doxorubicin in tumor tissue
- Evaluate Pharmacodynamics (PD) [ Time Frame: From start of treatment to approximately 12 weeks ]To assess immune response (changes in immune biomarkers) as assessed by PBMCs
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Phase 1: Inclusion Criteria:
- Diagnosis of advanced soft tissue sarcoma or other solid tumors
- Adequate hematologic, hepatic, renal, and coagulation function
- ECOG performance status score 0-1
- Tumor is the type where published clinical data would suggest that anthracyclines have cytotoxic activity
- Injectable tumor present
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
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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)
- 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
- 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.
- High grade STS, Grade 2/3, with an assessable/injectable lesion of at least diameter ≥5 cm by RECIST 1.1 criteria
- No prior chemotherapy for STS, or radiation to affected limb
Phase 2a Expansion Group 1 (Extremity STS): Exclusion
- Uncontrolled pain related to tumor
- Open wounds or tissue necrosis related to tumor mass
- Compartment syndrome or impending compartment syndrome
Phase 2a Expansion Group 2 (Unresectable STS): Inclusion
- Locally advanced or metastatic, unresectable, soft-tissue sarcoma of intermediate or high grade with measurable disease.
- Life expectancy >12 weeks (about 3 month)
Phase 2a Expansion Group 2 (Unresectable STS): Exclusion
- Prior exposure to anthracyclines
- Treatment naive extremity tumors
Phase 2a Expansion Group 3a (Head and Neck): Inclusion
- 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
- 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
- Airway obstruction by tumor mass that requires clinical intervention
- Prior treatment with anthracyclines
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106492
Contact: Shasqi Clinical Operations | 415-800-1376 | clinicalstudies@shasqi.com |
United States, California | |
City of Hope | Recruiting |
Duarte, California, United States, 91010 | |
Contact: Principal Investigator 415-800-1376 clinicalstudies@shasqi.com | |
Stanford Cancer Center | Recruiting |
Palo Alto, California, United States, 94304 | |
Contact: Principal Investigator 415-800-1376 clinicalstudies@shasqi.com | |
Sarcoma Oncology Center | Recruiting |
Santa Monica, California, United States, 90403 | |
Contact: Principal Investigator 415-800-1376 clinicalstudies@shasqi.com | |
United States, Missouri | |
Washington University in St. Louis | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Principal Investigator 415-800-1376 clinicalstudies@shasqi.com | |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Principal Investigator 415-800-1376 clinicalstudies@shasqi.com | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Principal Investigator 415-800-1376 clinicalstudies@shasqi.com | |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Principal Investigator 415-800-1376 clinicalstudies@shasqi.com | |
Australia, New South Wales | |
Chris O'Brien Lifehouse | Recruiting |
Camperdown, New South Wales, Australia, 2050 | |
Contact: Principal Investigator +1 415-800-1376 clinicalstudies@shasqi.com | |
Royal North Shore Hospital | Recruiting |
Sydney, New South Wales, Australia, 2065 | |
Contact: Principal Investigator +1 415-800-1376 clinicalstudies@shasqi.com | |
Australia, South Australia | |
Cancer Research Institute | Recruiting |
Adelaide, South Australia, Australia, 5000 | |
Contact: Principal Investigator +1 415-800-1376 clinicalstudies@shasqi.com |
Study Director: | Jim Williams, MD | Shasqi, Inc. |
Responsible Party: | Shasqi, Inc. |
ClinicalTrials.gov Identifier: | NCT04106492 |
Other Study ID Numbers: |
SQ3370-001 2020-0185 ( Other Identifier: MD Anderson Cancer Center ) |
First Posted: | September 27, 2019 Key Record Dates |
Last Update Posted: | February 9, 2023 |
Last Verified: | February 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |