Phase 1 Study of SQ3370 in Patients With Advanced Solid Tumors

Sponsor
Shasqi, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04106492
Collaborator
(none)
110
Enrollment
8
Locations
4
Arms
71.2
Anticipated Duration (Months)
13.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Aug 1, 2020
Anticipated Primary Completion Date :
Aug 7, 2024
Anticipated Study Completion Date :
Jul 9, 2026

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Dose Escalation Cohorts [From start of treatment to approximately 12 weeks]

    To determine the Maximum Tolerated Dose, if possible, and/or Recommended Phase 2 Dose of SQ3370

  2. Dose Expansion Cohorts [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

  1. Pharmacokinetics (PK) [From start of treatment to approximately 12 weeks]

    To determine Maximum Plasma concentration (Cmax) for SQP33 protodrug and active Dox following SQ3370 treatment

  2. Objective Response Rate (ORR) [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

  3. Duration of Response (DOR) [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

  1. Evaluate level of SQP33 in tumor [From start of treatment to approximately 12 weeks]

    To determine the level of SQP33 protodrug and active Doxorubicin in tumor tissue

  2. Evaluate Pharmacodynamics (PD) [From start of treatment to approximately 12 weeks]

    To assess immune response (changes in immune biomarkers) as assessed by PBMCs

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Diagnosis of advanced soft tissue sarcoma or other solid tumors

  2. Adequate hematologic, hepatic, renal, and coagulation function

  3. ECOG performance status score 0-1

  4. Tumor is the type where published clinical data would suggest that anthracyclines have cytotoxic activity

  5. Injectable tumor present

Exclusion Criteria:
  1. Prior exposure to 300 mg/m2 of Dox HCl or DOXIL / CAELYX ® or 600 mg/m2 of Epirubicin HCl

  2. Congestive heart failure (CHF), severe myocardial insufficiency, or cardiac arrhythmia

  3. 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)

  1. Trastuzumab or trastuzumab emtansine dosed within 7 months prior to Cycle 1 Day 1.

  2. Any transfusion within 14 days prior to Cycle 1 Day 1.

  3. Pregnant or breast-feeding women.

  4. 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

  5. History of allergic reactions attributed to Dox or other anthracyclines, NaHA, hyaluronic acid, or gram-positive bacterial proteins

  6. History or evidence of clinically unstable/uncontrolled disorder, condition, or disease

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Stanford Cancer CenterPalo AltoCaliforniaUnited States94304
2Sarcoma Oncology CenterSanta MonicaCaliforniaUnited States90403
3Washington University in St. LouisSaint LouisMissouriUnited States63110
4Mary Crowley Cancer ResearchDallasTexasUnited States75251
5MD Anderson Cancer CenterHoustonTexasUnited States77030
6Chris O'Brien LifehouseCamperdownNew South WalesAustralia2050
7Royal North Shore HospitalSydneyNew South WalesAustralia2065
8Cancer Research InstituteAdelaideSouth AustraliaAustralia5000

Sponsors and Collaborators

  • Shasqi, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shasqi, Inc.
ClinicalTrials.gov Identifier:
NCT04106492
Other Study ID Numbers:
  • SQ3370-001
  • 2020-0185
First Posted:
Sep 27, 2019
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
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.

Study Results

No Results Posted as of Nov 19, 2021