Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Head and Neck Neoplasms

Sarcoma

Uterine Neoplasms

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Doxorubicin

Liposomal doxorubicin

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.

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.

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.

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.

Locally advanced, unresectable or metastatic, soft tissue sarcomas who are anthracycline naïve.

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.

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

SQ3370

Shasqi Clinical Operations

Principal Investigator

Jim Williams, MD

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

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.

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

A Multicenter Phase 1/2a, Open-Label Study of SQ3370 in Patients With Advanced Solid Tumors

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

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

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

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

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

Defined as achievement of complete response (CR) or partial response (PR) by RECIST v1.1

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

Defined as the time between the date of enrollment to the date of death from any cause.

Determine plasma concentration and PK parameters for SQP33 protodrug and active Dox following SQ3370 treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors	NCT04106492	Cancer	SQ3370	18 Years -	Shasqi, Inc.
Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors	NCT04106492	Cancer	SQ3370	18 Years -	Shasqi, Inc.

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