Trial record 1 of 1 for:
sq3370
Phase 1 Study of SQ3370 in Patients With Advanced Solid Tumors
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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 |
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Recruitment Status :
Recruiting
First Posted : September 27, 2019
Last Update Posted : December 3, 2020
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Sponsor:
Shasqi, Inc.
Information provided by (Responsible Party):
Shasqi, Inc.
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Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of SQ3370 in patients with cancer (solid tumors).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer | Drug: SQ3370 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group 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 1, 2021 |
| Estimated Study Completion Date : | August 1, 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: SQ3370 |
Drug: SQ3370
SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin |
Primary Outcome Measures :
- Safety and tolerability of SQ3370, including determination of the maximum tolerated dose and the recommended Phase 2 dose. [ Time Frame: 35 Days ]
Information from the National Library of Medicine
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| 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 an advanced local or metastatic solid tumor
- Adequate hematologic, hepatic, renal, and coagulation function
- Tumor is a type where published clinical data would suggest is responsive to anthracyclines
Exclusion Criteria:
- Prior exposure to 225 mg/m^2 of Dox HCl or DOXIL / CAELYX ® or 450 mg/m^2 of epirubicin HCl.
- 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 (except for small molecule kinase inhibitors, which are 6 elimination half-lives)
- Currently enrolled in or discontinued from a clinical study involving an investigational agent or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
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 | |
| Stanford Cancer Center | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Principal Investigator 415-800-1376 clinicalstudies@shasqi.com | |
| United States, Michigan | |
| Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Principal Investigator 415-800-1376 clinicalstudies@shasqi.com | |
| United States, Texas | |
| 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 | |
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: | December 3, 2020 |
| Last Verified: | December 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Shasqi, Inc.:
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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 |