BOLD-100 + Doxorubicin for Cancer

Overseen By Albiruni Razak, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University Health Network, Toronto

Must not be taking: Anticancer therapies

Disqualifiers: Pregnancy, Prior systemic therapy, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 73

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of two drugs, BOLD-100 (an experimental treatment) and doxorubicin, to assess their safety and tolerability in people with advanced soft tissue sarcomas, a cancer affecting muscle, fat, and other tissues. The goal is to determine the highest safe dose of BOLD-100 when combined with doxorubicin. The trial consists of two parts: initially, it tests increasing doses of BOLD-100, then expands to more participants at the optimal dose. It suits those with advanced or metastatic soft tissue sarcoma who have not yet received systemic treatment. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have had chemotherapy, immunotherapy, or other systemic anticancer therapy within 3 weeks before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining BOLD-100 with another chemotherapy drug has been well-tolerated in other types of cancer. For example, one study found that BOLD-100, when used with a different chemotherapy treatment, was safe for patients with advanced colorectal cancer. There were no unexpected side effects, and patients generally managed the treatment well.

Doxorubicin, the other drug in this trial, is commonly used to treat various cancers. It has known side effects, such as nausea and hair loss, but these are common and manageable.

As this is an early phase trial, the main goal is to test the safety of this combination for people with soft tissue sarcomas. This phase often involves testing the treatment in humans for the first time, so safety data may be limited. However, past studies provide reason to be hopeful about its tolerability. Participants will be closely monitored to ensure their safety throughout the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BOLD-100 combined with Doxorubicin because it offers a fresh approach to cancer treatment. Unlike traditional chemotherapy agents that typically target rapidly dividing cells, BOLD-100 is designed to disrupt cancer cell stress responses, potentially making it effective against cancer types that are resistant to standard treatments. This combination aims to enhance the effectiveness of Doxorubicin, a well-established chemotherapy drug, by making cancer cells more susceptible to its action. By targeting stress response pathways, BOLD-100 could provide a novel mechanism to tackle tough-to-treat cancers, offering hope for improved outcomes.

What evidence suggests that BOLD-100 and doxorubicin could be effective for advanced soft tissue sarcomas?

Research has shown that BOLD-100 could be a promising cancer treatment. It stops cancer cells from repairing their DNA, making them more susceptible to other treatments. Lab studies have demonstrated that BOLD-100 can combat tumors in various human cancers. In this trial, participants will receive a combination of BOLD-100 and doxorubicin, a well-known chemotherapy drug. Early studies in other cancers have indicated that this combination can be more effective. Although still in the early stages of testing, this trial aims to enhance cancer-fighting ability by attacking cancer cells more powerfully together than either treatment would alone. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with advanced soft tissue sarcomas. Participants must pass a screening assessment to be eligible. The study excludes certain individuals, but specific exclusion criteria are not provided in the given information.

Inclusion Criteria

Written informed consent in accordance with federal, local, and institutional guidelines.

My sarcoma is advanced, cannot be surgically removed, and is one of the specific types listed.

My blood cell counts meet the required levels.

Exclusion Criteria

I am currently on approved or experimental cancer treatment.

Patient is pregnant or lactating.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Dose-Escalation Treatment

Participants receive BOLD-100 and doxorubicin in a dose-escalation phase to determine the highest dose with acceptable toxicity

Up to 18 weeks

Every 21 days (in-person)

Dose-Expansion Treatment

Participants receive BOLD-100 and doxorubicin at the recommended Phase 2 dose

Up to 18 weeks

Every 21 days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3 months

Post-treatment assessment at end of treatment and 30 days after last dose, then every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• BOLD-100
• Doxorubicin

Trial Overview The trial tests BOLD-100 combined with doxorubicin on a 21-day cycle, assessing safety and tolerability to find the highest dose that's safe (RP2D). It has two phases: initial dose-escalation with 12-15 patients and dose-expansion based on Phase 2 recommendations.

How Is the Trial Designed?

Group I: BOLD-100 and Doxorubicin Dose Level 3 Experimental Treatment 2 Interventions

Escalation phase DL3 - BOLD-100 625mg/m\^2 + Doxorubicin

Group II: BOLD-100 and Doxorubicin Dose Level 2 Experimental Treatment 2 Interventions

Escalation phase DL2 - BOLD-100 500mg/m\^2 + Doxorubicin

Group III: BOLD-100 and Doxorubicin Dose Level 1 Experimental Treatment 2 Interventions

Escalation phase DL1 - BOLD-100 420mg/m\^2 + Doxorubicin

Group IV: BOLD-100 and Doxorubicin Dose Level -1 Experimental Treatment 2 Interventions

Escalation phase DL-1 - BOLD-100 230mg/m\^2 + Doxorubicin

Group V: BOLD-100 and Doxorubicin Experimental Treatment 2 Interventions

Exapsnion: BOLD-100 (RP2D) and Doxorubicin

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07027423

BOLD-100 Plus Doxorubicin in Advanced Soft Tissue ... A Phase 1b, non-randomized, single-institution trial designed to assess the safety, tolerability and the highest dose with acceptable toxicity (RP2D) of ...

2. withpower.com withpower.com/trial/phase-1-sarcoma-5-2025-70908

BOLD-100 + Doxorubicin for Cancer · Info for Participants 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7563761/

Inhibition of DNA Repair Pathways and Induction of ROS ... BOLD-100 is a novel ruthenium-based drug that has shown anti-tumor effects in several human cancers. In this study, we investigated the biochemical changes ...

4. aacrjournals.org aacrjournals.org/mcr/article/22/12/1088/750092/Ruthenium-Drug-BOLD-100-Regulates-BRAFMT

Ruthenium Drug BOLD-100 Regulates BRAFMT Colorectal ... Also, we show that concomitant treatment with ATR inhibitors and BOLD-100 leads to marked increases in therapeutic efficacy in BRAFMT colorectal cancer. Taken ...

5. bold-therapeutics.com bold-therapeutics.com/files/2024_ASCO_POSTER.pdf

A Phase 2 study of BOLD-100 in combination with FOLFOX ... Treatment with FOLFOX together with BOLD-100 produced one partial response and several minor responses, durable stable disease and improvement in median ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/record/NCT07027423

BOLD-100 Plus Doxorubicin in Advanced Soft Tissue ... A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7616621/

Ruthenium Drug BOLD-100 Regulates BRAFMT Colorectal ... Taken together, our results indicate that combined BOLD-100 with ATR inhibition might represent a valuable targeting strategy for V600EBRAFMT colorectal cancer ...

8. bold-therapeutics.com bold-therapeutics.com/files/2024_ESMO_POSTER.pdf

BOLD-100-001 The combination of BOLD-100 plus FOLFOX is an active and well-tolerated treatment regimen in heavily pre-treated stage IV metastatic colorectal cancer patients ...