Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors

NCT04106492 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: SQ3370-0012020-0185
• Study Type: interventional
• Target: 53
• Locations: 2 countries
• Sites: 10

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of SQ3370 in patients with advanced solid tumors.

Conditions

Cancer

Keywords

Sarcoma; Cancer; Tumor; Soft Tissue Sarcoma; Solid Tumor; Doxorubicin; Intratumoral; Anthracycline; Phase 1; Ovarian Cancer; Precision Oncology; Precision Chemotherapy; Local Cancer Therapy; Targeted Cancer Therapy; Uterine Cancer; Head and Neck Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Phase 1 Cohorts

  To determine the Recommended Phase 2 Dose of SQ3370

  From start of treatment to approximately 12 weeks

Secondary Outcomes (1)

• Phase 2a: Objective Response Rate (ORR)

  Up to 1 year

Study Arms (15)

Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33)

EXPERIMENTAL

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 8 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

Drug: SQ3370

Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33)

EXPERIMENTAL

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 16 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors.

Drug: SQ3370

Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33)

EXPERIMENTAL

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 32 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors.

Drug: SQ3370

Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33)

EXPERIMENTAL

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 58 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors.

Drug: SQ3370

Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33)

EXPERIMENTAL

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

Drug: SQ3370

Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33)

EXPERIMENTAL

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

Drug: SQ3370

Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33)

EXPERIMENTAL

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

Drug: SQ3370

Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33)

EXPERIMENTAL

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

Drug: SQ3370

Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33)

EXPERIMENTAL

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 315 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

Drug: SQ3370

Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33)

EXPERIMENTAL

20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

Drug: SQ3370

Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33)

EXPERIMENTAL

20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

Drug: SQ3370

Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33)

EXPERIMENTAL

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

Drug: SQ3370

P2a Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33)

EXPERIMENTAL

20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with soft tissue sarcomas of the extremity

Drug: SQ3370

P2a Group 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 days and and 250 mg/m^2/ of SQP33 for 1 day)

EXPERIMENTAL

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 500 mg/m\^2 of SQP33 infused on Day 1 and 2 with 250 mg/m\^2 of SQP33 infused on each Day 3 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve

Drug: SQ3370

P2a Group 2 (10 mL SQL70 and 250 mg/m^2/day of SQP33 for five days)

EXPERIMENTAL

10 mL of SQL70 injected intratumorally on Day with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve

Drug: SQ3370

Interventions

SQ3370 DRUG

SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin

Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33); Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33); Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33); Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33); Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33); Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33); Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33); Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33); Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33); Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33); Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33); Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33); P2a Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33); P2a Group 2 (10 mL SQL70 and 250 mg/m^2/day of SQP33 for five days); P2a Group 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 days and and 250 mg/m^2/ of SQP33 for 1 day)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients with unresectable soft tissue sarcomas of the extremity AJCC Stage III OR select IV (=\>5 cm injectable tumors) locally advanced and or metastatic, not amendable to primary surgical intervention according to the consensus of a multidisciplinary treatment team, determined prior to screening.
• High grade STS, Grade 2/3, with an assessable/injectable lesion of at least diameter ≥5 cm by RECIST 1.1 criteria
• No prior chemotherapy for STS, or radiation to affected limb

Sponsors & Collaborators

• Shasqi, Inc.: lead

Study Sites (10)

City of Hope

Duarte, California, 91010, United States

Location

Stanford Cancer Center

Palo Alto, California, 94304, United States

Location

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Cancer Research Institute

Adelaide, South Australia, 5000, Australia

Location

Related Publications (2)

• Srinivasan S, Yee NA, Aleckovic M, Zakharian M, Mahmoodi A, Wagner S, Nguyen TH, Chawla SP, Guminski AD, Mejia Oneto JM. Development of a First-in-Class Click Chemistry-Based Cancer Therapeutic, from Preclinical Evaluation to a First-in-Human Dose Escalation Clinical Trial. Clin Cancer Res. 2025 Sep 2;31(17):3662-3677. doi: 10.1158/1078-0432.CCR-24-2539.

  PMID: 40522144 DERIVED

• Srinivasan S, Yee NA, Zakharian M, Aleckovic M, Mahmoodi A, Nguyen TH, Mejia Oneto JM. SQ3370, the first clinical click chemistry-activated cancer therapeutic, shows safety in humans and translatability across species. bioRxiv [Preprint]. 2023 Mar 29:2023.03.28.534654. doi: 10.1101/2023.03.28.534654.

  PMID: 37034617 DERIVED

MeSH Terms

Conditions

Neoplasms; Sarcoma; Ovarian Neoplasms; Uterine Neoplasms; Head and Neck Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Jose M. Mejia Oneto, MD, PhD
• Organization: Shasqi Inc

clinicalstudies@shasqi.com

415-800-1376

Study Officials

• Jim Williams, MD

  Shasqi, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1 dose escalation part of the study was done sequentially. The Phase 2 part of the study will be done in parallel between the four groups.

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: August 1, 2020
• Primary Completion: September 7, 2023
• Study Completion: September 7, 2023
• Last Updated: November 14, 2025
• Results First Posted: November 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); AU (3)