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Experimental cancer drug study halted early

NCT ID NCT04106492

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called SQ3370 in 53 people with advanced solid tumors that had spread or could not be removed by surgery. The goal was to check the drug's safety and find the best dose, as well as see if it could shrink tumors. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

53 people

The number who actually took part.

Started

Aug 2020

Finished

Sep 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Phase 1: 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 Phase 1: Exclusion Criteria: 1. Prior exposure to 300 mg/m\^2 of Dox HCl or DOXIL / CAELYX ® or 600 mg/m\^2 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) 4. Trastuzumab or trastuzumab emtansine dosed within 7 months prior to Cycle 1 Day 1. 5. Any transfusion within 14 days prior to Cycle 1 Day 1. 6. Pregnant or breast-feeding women. 7. 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 8. History of allergic reactions attributed to Dox or other anthracyclines, NaHA, hyaluronic acid, or gram-positive bacterial proteins 9. History or evidence of clinically unstable/uncontrolled disorder, condition, or disease Phase 2a Expansion Group 1 (Extremity STS): Inclusion 1. 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. 2. High grade STS, Grade 2/3, with an assessable/injectable lesion of at least diameter ≥5 cm by RECIST 1.1 criteria 3. No prior chemotherapy for STS, or radiation to affected limb Phase 2a Expansion Group 1 (Extremity STS): Exclusion 1. Uncontrolled pain related to tumor 2. Open wounds or tissue necrosis related to tumor mass 3. Compartment syndrome or impending compartment syndrome Phase 2a Expansion Group 2 (Unresectable STS): Inclusion 1. Locally advanced or metastatic, unresectable, soft-tissue sarcoma of intermediate or high grade with measurable disease. 2. Life expectancy \>12 weeks (about 3 month) Phase 2a Expansion Group 2 (Unresectable STS): Exclusion 1. Prior exposure to anthracyclines 2. Treatment naive extremity tumors Phase 2a Expansion Group 3a (Head and Neck): Inclusion 1. 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 2. 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 1. Airway obstruction by tumor mass that requires clinical intervention 2. Prior treatment with anthracyclines

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cancer Research Institute

    Adelaide, South Australia, 5000, Australia

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • City of Hope

    Duarte, California, 91010, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Royal North Shore Hospital

    Sydney, New South Wales, 2065, Australia

  • Sarcoma Oncology Center

    Santa Monica, California, 90403, United States

  • Stanford Cancer Center

    Palo Alto, California, 94304, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Washington University in St. Louis

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.