CancerPhase 1/2NCT04106492

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

A Phase 1/2 study testing SQ3370 in people with Cancer, run by Shasqi, Inc. at 10 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer
What is being tested?: SQ3370
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 10 sitesin 2 countries
Study dates: 1 Aug 2020to 7 Sep 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Phase 1: Inclusion Criteria:

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

Phase 1: Exclusion Criteria:

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

Phase 2a Expansion Group 1 (Extremity STS): Inclusion

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

Phase 2a Expansion Group 1 (Extremity STS): Exclusion

Uncontrolled pain related to tumor
Open wounds or tissue necrosis related to tumor mass
Compartment syndrome or impending compartment syndrome

Phase 2a Expansion Group 2 (Unresectable STS): Inclusion

Locally advanced or metastatic, unresectable, soft-tissue sarcoma of intermediate or high grade with measurable disease.
Life expectancy >12 weeks (about 3 month)

Phase 2a Expansion Group 2 (Unresectable STS): Exclusion

Prior exposure to anthracyclines
Treatment naive extremity tumors

Phase 2a Expansion Group 3a (Head and Neck): Inclusion

Patients with histologically or cytologically confirmed squamous-cell carcinoma of the head and neck (HNSCC) who meet any of the following a) confirmed relapsed HNSCC or b) metastatic at initial presentation HNSCC
Patients who may have received two or less systemic regimens (therapies include chemotherapy and/or immunotherapy)

Phase 2a Expansion Group 3a (Head and Neck): Exclusion

Airway obstruction by tumor mass that requires clinical intervention
Prior treatment with anthracyclines

Trial locations and contacts

10 sites in 2 countries.

Country

City, postcode or hospital

10 sites in 2 countries

United States7 sites

City of Hope
Duarte, California, 91010
MD Anderson Cancer Center
Houston, Texas, 77030
Stanford Cancer Center
Palo Alto, California, 94304
Oregon Health & Science University
Portland, Oregon, 97239
Sarcoma Oncology Center
Santa Monica, California, 90403
University of Washington
Seattle, Washington, 98195
Washington University in St. Louis
St Louis, Missouri, 63110

Other trials in United States

Australia3 sites

Cancer Research Institute
Adelaide, South Australia, 5000
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Royal North Shore Hospital
Sydney, New South Wales, 2065

Other trials in Australia

About this study

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

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

Conditions: Cancer
Being tested: SQ3370
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
Medical subject headings: Neoplasms, Sarcoma, Ovarian Neoplasms, Uterine Neoplasms, Head and Neck Neoplasms, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SQ3370Drug
SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin

Study groups in NCT04106492
Study group	Role	What they receive
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 Receives: 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. Receives: 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. Receives: 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. Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: SQ3370

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1 Cohorts
To determine the Recommended Phase 2 Dose of SQ3370
Measured: From start of treatment to approximately 12 weeks

Secondary outcomes (1)

Phase 2a: Objective Response Rate (ORR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20207 Sep 2023

First posted27 Sep 2019
Study start1 Aug 2020
Primary completion7 Sep 2023
Study completion7 Sep 2023

Why it stopped: Sponsor's decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04106492
Sponsor's protocol ID: SQ3370-001
Other IDs: 2020-0185
Status last verified: Oct 2025
First submitted: 25 Sep 2019
Last updated: 14 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40522144
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.
PubMed 37034617

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Phase 1/2a, Open-Label Study of SQ3370 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT04106492
Acronym / sponsor ID: SQ3370-001
Conditions: Cancer
Keywords: Sarcoma, Cancer, Tumor, Soft Tissue Sarcoma, Solid Tumor, Doxorubicin, Intratumoral, Anthracycline
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor's decision
Enrolment: 53 participants (actual)
Lead sponsor: Shasqi, Inc.Industry (pharma, biotech, devices)
Study start: 1 Aug 2020 (actual)
Primary completion: 7 Sep 2023 (actual)
Study completion: 7 Sep 2023 (actual)
First posted: 27 Sep 2019 (actual)
Results: Posted 14 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 15
Model description: 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.

Arm	Type	Receives
Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33)	Experimental	Drug: SQ337010 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
Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33)	Experimental	Drug: SQ337010 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.
Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33)	Experimental	Drug: SQ337010 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.
Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33)	Experimental	Drug: SQ337010 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.
Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33)	Experimental	Drug: SQ337010 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
Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33)	Experimental	Drug: SQ337010 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
Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33)	Experimental	Drug: SQ337010 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
Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33)	Experimental	Drug: SQ337010 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
Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33)	Experimental	Drug: SQ337010 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
Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33)	Experimental	Drug: SQ337020 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
Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33)	Experimental	Drug: SQ337020 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
Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33)	Experimental	Drug: SQ337010 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
P2a Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33)	Experimental	Drug: SQ337020 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
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	Drug: SQ337010 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
P2a Group 2 (10 mL SQL70 and 250 mg/m^2/day of SQP33 for five days)	Experimental	Drug: SQ337010 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SQ3370SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin	Drug	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)

Primary outcome

Phase 1 Cohorts
Time frame: From start of treatment to approximately 12 weeks
To determine the Recommended Phase 2 Dose of SQ3370

1 secondary outcome

Phase 2a: Objective Response Rate (ORR)
Time frame: Up to 1 year

Results and safety

Results posted to the registry on 14 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33)	1	1
Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33)	1	1
Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33)	1	1
Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33)	3	3
Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33)	3	3
Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33)	4	4
Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33)	4	4
Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33)	7	7
Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33)	6	6
Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33)	5	5
Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33)	3	3
Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33)	1	1
Phase 2a Expansion Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33)	2	2
P2a Grp 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)	6	6
P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days)	6	6

Primary outcome: Phase 1 Cohorts

Time frame: From start of treatment to approximately 12 weeks. Number. Unit: mg/m2 per cycle

Measure	Dose Escalation Cohort (10 mL SQL70) n = 30	Dose Escalation Cohort (20 mL SQL70) n = 8
Value	1250	1250

Population analysed: Dose escalation participants

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33)	1 of 1 (100%)	1 of 1 (100%)	1 of 1
Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33)	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33)	1 of 1 (100%)	1 of 1 (100%)	0 of 1
Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33)	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33)	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33)	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33)	2 of 4 (50%)	4 of 4 (100%)	0 of 4
Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33)	2 of 7 (28.6%)	7 of 7 (100%)	0 of 7
Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33)	1 of 5 (20%)	5 of 5 (100%)	0 of 5
Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33)	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33)	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Phase 2a Expansion Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33)	0 of 2 (0%)	2 of 2 (100%)	0 of 2
P2a Grp 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)	2 of 6 (33.3%)	6 of 6 (100%)	1 of 6
P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days)	1 of 6 (16.7%)	6 of 6 (100%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40522144Srinivasan 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.
Derived from this study: PubMed 37034617Srinivasan 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jim Williams, MD study director

Shasqi, Inc.

10 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SQ3370 in people with Cancer, run by Shasqi, Inc. at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1 Cohorts (time frame: From start of treatment to approximately 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04106492, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.