Sarcoma, Soft-tissuePhase 1NCT07027423
BOLD-100 Plus Doxorubicin in Advanced Soft Tissue Sarcomas
A Phase 1 study testing BOLD-100 and Doxorubicin 75 mg/m^2 in people with Sarcoma, Soft-tissue and Sarcoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
A Phase 1b, non-randomized, single-institution trial designed to assess the safety, tolerability and the highest dose with acceptable toxicity (RP2D) of BOLD-100 in combination with doxorubicin in patients diagnosed with advanced soft tissue sarcomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Soft-tissue, Sarcoma, Sarcoma,Soft Tissue
- What is being tested?
- BOLD-100 and Doxorubicin 75 mg/m^2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2026to 29 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Written informed consent in accordance with federal, local, and institutional guidelines.
- Age > 18 years.
- Patients must have histologically confirmed locally advanced/unresectable or metastatic soft tissue sarcoma of limited subtype LMS, DDLPS and UPS (including Myxofibrosarcoma-MFS).
- Patients be systemic treatment naïve, with incurable, advanced or metastatic disease.
- Patient must have measurable disease as defined by RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Adequate hematopoietic function:
- total white blood cell (WBC) count ≥2000/mm3.
- absolute neutrophil count (ANC) ≥1500/mm3.
- platelet count ≥100,000/mm3.
- Adequate hepatic function:
- 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).
- 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.
- Adequate renal function defined as <1.5x upper limits of normal
- 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.
- 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.
Who cannot join
- Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Patient is pregnant or lactating.
- 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.
- Major surgery within 4 weeks before initiation of therapy.
- Prior systemic therapy.
- Unstable cardiovascular function:
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- symptomatic ischemia, or.
- 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.
- congestive heart failure (CHF) of NYHA Class ≥3, or.
- myocardial infarction (MI) within 3 months of initiation of therapy.
- Active, ongoing or uncontrolled active infection within one week prior to first dose.
- 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.
- Known to be HIV seropositive.
- 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).
- 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.
- Serious psychiatric or medical conditions that could interfere with treatment.
- Concurrent therapy with approved or investigational anticancer therapeutic agents.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1b Trial of BOLD-100 Plus Doxorubicin in Advanced Soft Tissue Sarcomas
A Phase 1b, non-randomized, single-institution trial designed to assess the safety, tolerability and the highest dose with acceptable toxicity (RP2D) of BOLD-100 in combination with doxorubicin in patients diagnosed with advanced soft tissue sarcomas. The trial is divided into two phases: an initial dose-escalation phase for BOLD-100, followed by a dose-expansion phase based on the recommended dose for Phase 2. In the dose-escalation phase, we plan to enroll 12-15 patients, with an additional 17 patients in the dose-expansion phase.
Participants will receive BOLD-100 intravenously on Days 1 and 8 of a 21-day cycle, in combination with doxorubicin (75 mg/m², intravenous) administered on Day 1 of each 21-day cycle for up to six cycles. Participants will continue to receive BOLD-100 for as long as the cancer is not getting worse, The maximum cycles of doxorubicin are 6 cycles.
Read more
Participants will undergo a screening assessment prior to the start treatment to determine eligibility for enrollment. Treatment will commence on Day 1 and will continue until the protocol-defined criteria for treatment withdrawal are met. Disease response will be assessed using CT or MRI scans, starting at 12 weeks after the initiation of treatment and continuing every 12 weeks until withdrawal.
Upon treatment discontinuation or study withdrawal, a post-treatment assessment will be conducted at end of treatment and at 30 days of the last BOLD-100 dose, with follow-up visits scheduled every 3 months thereafter.
- Conditions
- Sarcoma, Soft-tissue, Sarcoma, Sarcoma,Soft Tissue, Sarcomas
- Being tested
- BOLD-100, Doxorubicin 75 mg/m^2
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOLD-100Drug
BOLD-100 in combination with Doxorubicin (Escalation)
Doxorubicin 75 mg/m^2Drug
BOLD-100 in combination with Doxorubicin (Escalation)
BOLD-100Drug
BOLD-100 in combination with Doxorubicin (Expansion)
Doxorubicin 75 mg/m^2Drug
BOLD-100 in combination with Doxorubicin (Expansion)
| Study group | Role | What they receive |
|---|---|---|
| BOLD-100 and Doxorubicin Dose Level -1 | Experimental | Escalation phase DL-1 - BOLD-100 230mg/m^2 + Doxorubicin Receives: Drug: BOLD-100; Drug: Doxorubicin 75 mg/m^2 |
| BOLD-100 and Doxorubicin Dose Level 1 | Experimental | Escalation phase DL1 - BOLD-100 420mg/m^2 + Doxorubicin Receives: Drug: BOLD-100; Drug: Doxorubicin 75 mg/m^2 |
| BOLD-100 and Doxorubicin Dose Level 2 | Experimental | Escalation phase DL2 - BOLD-100 500mg/m^2 + Doxorubicin Receives: Drug: BOLD-100; Drug: Doxorubicin 75 mg/m^2 |
| BOLD-100 and Doxorubicin Dose Level 3 | Experimental | Escalation phase DL3 - BOLD-100 625mg/m^2 + Doxorubicin Receives: Drug: BOLD-100; Drug: Doxorubicin 75 mg/m^2 |
| BOLD-100 and Doxorubicin | Experimental | Exapsnion: BOLD-100 (RP2D) and Doxorubicin Receives: Drug: BOLD-100; Drug: Doxorubicin 75 mg/m^2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of dose limiting toxicities (DLTs)
Measured: Entire duration of Cycle 1 (21 day cycle)
The rate of Adverse Events (AE)
The rate of Adverse Events (AE) characterized by type, frequency, severity graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0
Measured: time the consent form is signed through 12 months following cessation of treatment
Rate of toxicities
Rate of toxicities as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0, adverse events (AEs), serious AEs (SAEs), dose interruptions and assessment.
Measured: time the consent form is signed through 12 months following cessation of treatment.
Participant Quality of Life
Assessed using EORTC QLQ-C30 (European Organization For Research And Treatment Of Cancer, Core Quality of Life Questionnaire). With scores from 0 to 100. A high scale score represents a higher response level.
Measured: pre-dose, Cycle 2 Day1, Cycle 7 Day 1, Cycle 12 Day 1 (21 day cycles)
Secondary outcomes (4)
Progression-free survival (PFS)
Progression-free survival (PFS), response rate using RECIST v 1.1, clinical benefit rate (CR, PR, SD >16 weeks) using the Kaplan Meier method to estimate with corresponding 95% CI
Measured: time the consent form is signed through treatment completion, up to 4-6 weeks after progression if applicable
Analysis of pharmacokinetic parameters of doxorubicin and BOLD-100
Analysis of pharmacokinetic parameters of doxorubicin and BOLD-100 (in the first 3 patients per dose level) using Peak Plasma Concentration (Cmax), which will be compared to single agent population PK of doxorubicin and BOLD-100.
Measured: During Cycle 1 pre-dose, 1hour, 2hours and 48hours post-dose, through Cycle 2 pre-dose (21 day cycles)
Analysis of pharmacokinetic parameters of doxorubicin and BOLD-100
Analysis of pharmacokinetic parameters of doxorubicin and BOLD-100 (in the first 3 patients per dose level) using area under the plasma concentration versus time curve (AUC), which will be compared to single agent population PK of doxorubicin and BOLD-100.
Measured: During Cycle 1 pre-dose, 1hour, 2hours and 48hours post-dose, through Cycle 2 pre-dose (21 day cycles)
Analysis of pharmacokinetic parameters of doxorubicin and BOLD-100
Analysis of pharmacokinetic parameters of doxorubicin and BOLD-100 (in the first 3 patients per dose level) using time to peak drug concentration (Tmax), which will be compared to single agent population PK of doxorubicin and BOLD-100.
Measured: During Cycle 1 pre-dose, 1hour, 2hours and 48hours post-dose, through Cycle 2 pre-dose (21 day cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start30 Mar 2026 (estimated)
- Primary completion29 Jan 2027 (estimated)
- Study completion29 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma, Soft-tissueStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027423
- Sponsor's protocol ID
- BOLDSARC-01
- Status last verified
- Nov 2025
- First submitted
- 30 Apr 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Trial of BOLD-100 Plus Doxorubicin in Advanced Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT07027423
- Acronym / sponsor ID
- BOLDSARC-01
- Conditions
- Sarcoma, Soft-tissue, Sarcoma, Sarcoma,Soft Tissue, Sarcomas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 29 Jan 2027 (estimated)
- Study completion
- 29 Jan 2027 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1b, non-randomized, single-institution trial designed to assess the safety, tolerability and the highest dose with acceptable toxicity (RP2D) of BOLD-100 in combination with doxorubicin in patients diagnosed with advanced soft tissue sarcomas. The trial is divided into two phases: an initial dose-escalation phase for BOLD-100, followed by a dose-expansion phase based on the recommended dose for Phase 2. In the dose-escalation phase, we plan to enroll 12-15 patients, with an additional 17 patients in the dose-expansion phase.
Participants will receive BOLD-100 intravenously on Days 1 and 8 of a 21-day cycle, in combination with doxorubicin (75 mg/m², intravenous) administered on Day 1 of each 21-day cycle for up to six cycles. Participants will continue to receive BOLD-100 for as long as the cancer is not getting worse, The maximum cycles of doxorubicin are 6 cycles.
Participants will undergo a screening assessment prior to the start treatment to determine eligibility for enrollment. Treatment will commence on Day 1 and will continue until the protocol-defined criteria for treatment withdrawal are met. Disease response will be assessed using CT or MRI scans, starting at 12 weeks after the initiation of treatment and continuing every 12 weeks until withdrawal.
Upon treatment discontinuation or study withdrawal, a post-treatment assessment will be conducted at end of treatment and at 30 days of the last BOLD-100 dose, with follow-up visits scheduled every 3 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BOLD-100 and Doxorubicin Dose Level -1 | Experimental | Drug: BOLD-100, Drug: Doxorubicin 75 mg/m^2Escalation phase DL-1 - BOLD-100 230mg/m^2 + Doxorubicin |
| BOLD-100 and Doxorubicin Dose Level 1 | Experimental | Drug: BOLD-100, Drug: Doxorubicin 75 mg/m^2Escalation phase DL1 - BOLD-100 420mg/m^2 + Doxorubicin |
| BOLD-100 and Doxorubicin Dose Level 2 | Experimental | Drug: BOLD-100, Drug: Doxorubicin 75 mg/m^2Escalation phase DL2 - BOLD-100 500mg/m^2 + Doxorubicin |
| BOLD-100 and Doxorubicin Dose Level 3 | Experimental | Drug: BOLD-100, Drug: Doxorubicin 75 mg/m^2Escalation phase DL3 - BOLD-100 625mg/m^2 + Doxorubicin |
| BOLD-100 and Doxorubicin | Experimental | Drug: BOLD-100, Drug: Doxorubicin 75 mg/m^2Exapsnion: BOLD-100 (RP2D) and Doxorubicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Written informed consent in accordance with federal, local, and institutional guidelines.
- Age > 18 years.
- Patients must have histologically confirmed locally advanced/unresectable or metastatic soft tissue sarcoma of limited subtype LMS, DDLPS and UPS (including Myxofibrosarcoma-MFS).
- Patients be systemic treatment naïve, with incurable, advanced or metastatic disease.
- Patient must have measurable disease as defined by RECIST 1.1.
Key exclusion criteria (18 listed)
- Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Patient is pregnant or lactating.
- 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.
- Major surgery within 4 weeks before initiation of therapy.
- Prior systemic therapy.
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 |
|---|---|---|
| BOLD-100BOLD-100 in combination with Doxorubicin (Escalation) | Drug | BOLD-100 and Doxorubicin Dose Level -1, BOLD-100 and Doxorubicin Dose Level 1, BOLD-100 and Doxorubicin Dose Level 2, BOLD-100 and Doxorubicin Dose Level 3 |
| Doxorubicin 75 mg/m^2BOLD-100 in combination with Doxorubicin (Escalation) | Drug | BOLD-100 and Doxorubicin Dose Level -1, BOLD-100 and Doxorubicin Dose Level 1, BOLD-100 and Doxorubicin Dose Level 2, BOLD-100 and Doxorubicin Dose Level 3 |
| BOLD-100BOLD-100 in combination with Doxorubicin (Expansion) | Drug | BOLD-100 and Doxorubicin |
| Doxorubicin 75 mg/m^2BOLD-100 in combination with Doxorubicin (Expansion) | Drug | BOLD-100 and Doxorubicin |
Primary outcome
The incidence of dose limiting toxicities (DLTs)
Time frame: Entire duration of Cycle 1 (21 day cycle)
The rate of Adverse Events (AE)
Time frame: time the consent form is signed through 12 months following cessation of treatment
The rate of Adverse Events (AE) characterized by type, frequency, severity graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0
Rate of toxicities
Time frame: time the consent form is signed through 12 months following cessation of treatment.
Rate of toxicities as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0, adverse events (AEs), serious AEs (SAEs), dose interruptions and assessment.
Participant Quality of Life
Time frame: pre-dose, Cycle 2 Day1, Cycle 7 Day 1, Cycle 12 Day 1 (21 day cycles)
Assessed using EORTC QLQ-C30 (European Organization For Research And Treatment Of Cancer, Core Quality of Life Questionnaire). With scores from 0 to 100. A high scale score represents a higher response level.
4 secondary outcomes
Progression-free survival (PFS)
Time frame: time the consent form is signed through treatment completion, up to 4-6 weeks after progression if applicable
Analysis of pharmacokinetic parameters of doxorubicin and BOLD-100
Time frame: During Cycle 1 pre-dose, 1hour, 2hours and 48hours post-dose, through Cycle 2 pre-dose (21 day cycles)
Analysis of pharmacokinetic parameters of doxorubicin and BOLD-100
Time frame: During Cycle 1 pre-dose, 1hour, 2hours and 48hours post-dose, through Cycle 2 pre-dose (21 day cycles)
Analysis of pharmacokinetic parameters of doxorubicin and BOLD-100
Time frame: During Cycle 1 pre-dose, 1hour, 2hours and 48hours post-dose, through Cycle 2 pre-dose (21 day cycles)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BOLD-100 and Doxorubicin 75 mg/m^2 in people with Sarcoma, Soft-tissue and Sarcoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 18 exclusion criteria. 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: opening soon, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albiruni Razak, MD (416 586 5371, Albiruni.razak@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of dose limiting toxicities (DLTs) (time frame: Entire duration of Cycle 1 (21 day cycle)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2025.