Phase 1 Study of SQ3370 in Patients With Advanced Solid Tumors
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04106492 |
|
Recruitment Status :
Recruiting
First Posted : September 27, 2019
Last Update Posted : July 4, 2022
|
Sponsor:
Shasqi, Inc.
Information provided by (Responsible Party):
Shasqi, Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of SQ3370 in patients with advanced solid tumors.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer | Drug: SQ3370 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 110 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter Phase 1, 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Dose Escalation Cohort (10 mLSQL70)
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.
|
Drug: SQ3370
SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin |
|
Experimental: Dose Escalation Cohort (20 mLSQL70)
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.
|
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: Cohort B & C
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 the 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 |
Primary Outcome Measures :
- Dose Escalation 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
- Dose Expansion Cohorts [ Time Frame: From first dose to approximately 24 weeks ]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
Secondary Outcome Measures :
- 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
- Objective Response Rate (ORR) [ Time Frame: From start of treatment to end of follow up or 72 weeks after accrual of the final subject ]Defined as achievement of complete response (CR) or partial response (PR) by RECIST v1.1
- Duration of Response (DOR) [ Time Frame: From start of treatment to end of follow up or 72 weeks after accrual of the final subject ]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
Other Outcome Measures:
- 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
Information from the National Library of Medicine
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 |
Criteria
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
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:
- 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
Information from the National Library of Medicine
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
Contacts
| Contact: Shasqi Clinical Operations | 415-800-1376 | clinicalstudies@shasqi.com |
Locations
| United States, California | |
| City of Hope | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Mark Agulnik 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: Christopher Ryan 415-800-1376 clinicalstudies@shasqi.com | |
| United States, Texas | |
| Mary Crowley Cancer Research | Recruiting |
| Dallas, Texas, United States, 75251 | |
| Contact: Principal Investigator 415-800-1376 clinicalstudies@shasqi.com | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Vivek Subbiah, MD 713-563-0393 VSubbiah@mdanderson.org | |
| Australia, New South Wales | |
| Chris O'Brien Lifehouse | Recruiting |
| Camperdown, New South Wales, Australia, 2050 | |
| Contact: Principal Investigator 415-800-1376 clinicalstudies@shasqi.com | |
| Royal North Shore Hospital | Recruiting |
| Sydney, New South Wales, Australia, 2065 | |
| Contact: Principal Investigator 415-800-1376 clinicalstudies@shasqi.com | |
| Australia, South Australia | |
| Cancer Research Institute | Recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Contact: Principal Investigator 415-800-1376 clinicalstudies@shasqi.com | |
Sponsors and Collaborators
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: | July 4, 2022 |
| Last Verified: | June 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Shasqi, Inc.:
|
Sarcoma Cancer Tumor Soft Tissue Sarcoma Solid Tumor Doxorubicin Intratumoral Anthracycline Phase 1 Lung Cancer Breast Cancer |
Ovarian Cancer Pancreatic Cancer Esophageal Cancer Precision Oncology Precision Chemotherapy Local Cancer Therapy Targeted Cancer Therapy Bladder Cancer Gastric Tumor Skin Cancer Melanoma |