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Unknown

SQ3370 for Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Shasqi, Inc.
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 below
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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 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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 more
Other 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.

Find a Location

Who is running the clinical trial?

Shasqi, Inc.Lead Sponsor
Jim Williams, MDStudy DirectorShasqi, Inc.

Media Library

SQ3370 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04106492 — Phase 1 & 2
Cancer Research Study Groups: Dose Escalation Cohort (20 mL SQL70), Phase 2a Expansion Group 3a (Head and Neck), Cohort A, Dose Escalation Cohort (10 mL SQL70), Phase 2a Expansion Group 1 (Extremity STS), Phase 2a Expansion Group 2 (Unresectable STS)
Cancer Clinical Trial 2023: SQ3370 Highlights & Side Effects. Trial Name: NCT04106492 — Phase 1 & 2
SQ3370 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04106492 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please tell me how many different places are in charge of this trial?

"There are 11 trial locations for this study, which are currently enrolling patients. Some of these sites include Sarcoma Oncology Center in Santa Monica, California, Mary Crowley Cancer Research in Dallas, Texas, and Oregon Health & Science University in Portland, Oregon."

Answered by AI

Why was this clinical trial designed, and what are its key goals?

"The sponsor of this clinical trial, Shasqi, Inc., reports that the primary objective is Phase 2a Expansion Groups. This will be measured over a 12-week period from the start of treatment. Additionally, there are secondary objectives including but not limited to: measuring plasma concentration and PK parameters for SQP33 protodrug and active Dox following SQ3370 treatment (Phase 2a: Pharmacokinetics), determining the time between enrollment and death from any cause (Phase 2a: Overall Survival), and finally, to determine Maximum Plasma concentration (Cmax) for SQP33 protodrug and active Dox following SQ33"

Answered by AI

How many people are receiving care through this research project?

"One hundred and forty-five patients are required to carry out this clinical trial according to the current inclusion criteria. The sponsor, Shasqi, Inc., will manage the study from centres in Sarcoma Oncology Center (Santa Monica, California) and Mary Crowley Cancer Research (Dallas, Texas)."

Answered by AI

Are there still room for participants in this research?

"Yes, this trial is still open and recruiting patients according to the latest update on clinicaltrials.gov from September 16th, 2022. The original posting was on August 1st, 2020."

Answered by AI

Who else is applying?

What state do they live in?
Washington
What site did they apply to?
University of Washington
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors
2020. "Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04106492.
~9 spots leftby Aug 2024
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