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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of advanced soft tissue sarcoma or other solid tumors
Tumor is the type where published clinical data would suggest that anthracyclines have cytotoxic activity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and effective for treating patients with advanced solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors where anthracyclines might help. They should be relatively fit (ECOG score 0-1), have a tumor that can be injected, and their body's blood-making, liver, kidney, and clotting functions should be good. People who've had lots of Dox or Epirubicin, heart issues, recent cancer treatments except certain kinase inhibitors, recent transfusions or are pregnant/breastfeeding can't join.Check my eligibility
What is being tested?
The study tests SQ3370's safety and early effectiveness in treating advanced solid tumors. It's an initial phase trial to see how patients tolerate the drug and if it shows any promise against these cancers.See study design
What are the potential side effects?
While specific side effects of SQ3370 aren't listed here as it’s new and being tested for the first time in humans, common side effects from similar cancer drugs include nausea, fatigue, risk of infection due to low blood cell counts, hair loss and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with advanced soft tissue sarcoma or another type of solid tumor.
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My cancer type responds to a specific chemotherapy drug.
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I am fully active or can carry out light work.
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I have a tumor that can be injected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1 Cohorts
Phase 2a Expansion Groups
Secondary outcome measures
Phase 1: Duration of Response (DOR)
Phase 1: Objective Response Rate (ORR)
Phase 1: Pharmacokinetics (PK)
+4 moreOther outcome measures
Evaluate Pharmacodynamics (PD)
Evaluate level of SQP33 in tumor
Trial Design
6Treatment groups
Experimental Treatment
Group I: Phase 2a Expansion Group 3a (Head and Neck)Experimental Treatment1 Intervention
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.
Group II: Phase 2a Expansion Group 2 (Unresectable STS)Experimental Treatment1 Intervention
Locally advanced, unresectable or metastatic, soft tissue sarcomas who are anthracycline naïve.
Group III: Phase 2a Expansion Group 1 (Extremity STS)Experimental Treatment1 Intervention
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.
Group IV: Dose Escalation Cohort (20 mL SQL70)Experimental Treatment1 Intervention
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.
Group V: Dose Escalation Cohort (10 mL SQL70)Experimental Treatment1 Intervention
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.
Group VI: Cohort AExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Shasqi, Inc.Lead Sponsor
Jim Williams, MDStudy DirectorShasqi, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to Dox, hyaluronic acid, or certain bacterial proteins.I do not have any uncontrolled health conditions.I have been diagnosed with advanced soft tissue sarcoma or another type of solid tumor.I have received Trastuzumab or Trastuzumab emtansine within the last 7 months.I have not had any major surgeries recently.My cancer type responds to a specific chemotherapy drug.I am fully active or can carry out light work.My blood, liver, kidney, and clotting tests are within normal ranges.I have stable brain metastases after treatment.I have previously received a specific dose of Doxorubicin or Epirubicin.I have a tumor that can be injected.I am not currently on chemotherapy, immunotherapy, or anticancer therapy.I have not had a blood transfusion in the last 14 days.I am currently undergoing or have completed radiotherapy.I have severe heart issues, including heart failure or irregular heartbeat.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation Cohort (20 mL SQL70)
- Group 2: Phase 2a Expansion Group 3a (Head and Neck)
- Group 3: Cohort A
- Group 4: Dose Escalation Cohort (10 mL SQL70)
- Group 5: Phase 2a Expansion Group 1 (Extremity STS)
- Group 6: Phase 2a Expansion Group 2 (Unresectable STS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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