Experimental drug combo takes on rare sarcomas
NCT ID NCT07027423
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a new drug called BOLD-100 combined with standard chemotherapy (doxorubicin) in 32 people with advanced soft tissue sarcomas that cannot be removed by surgery or have spread. The goal is to find the safest dose and see if the combination can shrink tumors or slow the cancer. Participants get the drugs intravenously in 21-day cycles, with scans every 12 weeks to check response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BOLD-100 (a ruthenium-based drug) combined with doxorubicin (chemotherapy)
- What this could lead to
- If it works, this could lead to a new treatment option for advanced soft tissue sarcomas that may help control the disease longer.
- What could go wrong
- This is a very early Phase 1b trial with only 32 people, so it's mainly checking safety and dosing. It may not show strong anti-cancer effects, and side effects from the combination are unknown.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Inclusion Criteria 1. Written informed consent in accordance with federal, local, and institutional guidelines. 2. Age \> 18 years. 3. Patients must have histologically confirmed locally advanced/unresectable or metastatic soft tissue sarcoma of limited subtype LMS, DDLPS and UPS (including Myxofibrosarcoma-MFS). 4. Patients be systemic treatment naïve, with incurable, advanced or metastatic disease. 5. Patient must have measurable disease as defined by RECIST 1.1. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Adequate hematopoietic function: 1. total white blood cell (WBC) count ≥2000/mm3. 2. absolute neutrophil count (ANC) ≥1500/mm3. 3. platelet count ≥100,000/mm3. 8. Adequate hepatic function: 1. Bilirubin \<2 times the upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of \< 3 times ULN). 2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5 X ULN. In the case of known (radiological and/or biopsy documented) liver metastasis, ALT/AST \<5.0 X ULN is acceptable. 9. Adequate renal function defined as \<1.5x upper limits of normal 10. Cardiac function: A normal left ventricular ejection fraction (LVEF) of \> 50% as evidenced by an echocardiogram or nuclear medicine study performed within 28 days of the proposed study commencement. 11. Female patients of childbearing potential must agree to use two methods of contraception (including one highly effective and one effective method of contraception) and have a negative serum pregnancy test at 72 hours prior to receiving the first dose of study medication. Male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose of study treatment. Exclusion Criteria Subjects should not enter the study if any of the following exclusion criteria are fulfilled: 1. Patient is pregnant or lactating. 2. Radiation (except planned or ongoing palliative radiation outside of the region of measurable disease), chemotherapy, immunotherapy, any other systemic anticancer therapy, or participation in an investigational anti-cancer study ≤3 weeks prior to initiation of therapy. 3. Major surgery within 4 weeks before initiation of therapy. 4. Prior systemic therapy. 5. Unstable cardiovascular function: 1. symptomatic ischemia, or. 2. uncontrolled clinically significant conduction abnormalities (e.g., ventricular tachycardia on anti-arrhythmic is excluded and 1st degree AV block or asymptomatic LAFB/RBBB will not be excluded) or. 3. congestive heart failure (CHF) of NYHA Class ≥3, or. 4. myocardial infarction (MI) within 3 months of initiation of therapy. 6. Active, ongoing or uncontrolled active infection within one week prior to first dose. 7. Malignancies other than disease under study within 2 years prior to Cycle 1, Day 1, except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ). Prior chemotherapy is allowed apart from regimens that contained anthracycline based therapies. 8. Known to be HIV seropositive. 9. Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) RNA or hepatitis B virus (HBV) surface antigen (HBsAg). 10. Patients with active CNS malignancy. Asymptomatic small lesions are not considered active. Treated lesions may be considered inactive if they are stable for at least 3 months. 11. Serious psychiatric or medical conditions that could interfere with treatment. 12. Concurrent therapy with approved or investigational anticancer therapeutic agents. 13. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study regimen or interpretation of patient safety or study results.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UHN- Princess Margaret Cancer Center
Toronto, Ontario, M5G 1Z5, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Blood-Flow-Blocking drug stall a rare sarcoma?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a dual immune antibody plus radiation shrink metastatic sarcoma?
- Can a new drug shrink advanced solid tumors?
- Can a coordinated care team reduce severe side effects in older cancer patients?
- Can repeated MRI scans reveal how tumors respond to radiation?