90 Participants Needed

DSB2455 for Cancer

Recruiting at 10 trial locations
DS
Overseen ByDuke Street Bio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, DSB2455, to determine its safety and effectiveness for treating advanced breast, prostate, or ovarian cancer that has spread to the brain. Researchers aim to find the best dose of DSB2455 and understand its mechanism in the body. Suitable participants have these types of cancer, measurable disease, and brain metastasis confirmed by an MRI. Participants should not have certain other medical conditions or treatments that might interfere with the trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received systemic anti-cancer therapy or investigational agents within 4 weeks before starting the study, and certain other treatments like chronic steroids or live vaccines are restricted close to the trial start.

Is there any evidence suggesting that DSB2455 is likely to be safe for humans?

Research has shown that DSB2455 was safe in early lab and animal studies, indicating the treatment was well-tolerated and did not cause serious harm in those tests. These positive results enabled researchers to begin human trials. Now in the early stages of human trials, the main focus is on assessing its safety for people. This phase involves closely monitoring participants' reactions to the treatment, including any side effects. So far, no serious safety issues have been reported, which is encouraging for prospective trial participants.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about DSB2455 for cancer because it offers a novel approach that differs from traditional treatments like chemotherapy and radiation. DSB2455 is unique because it involves a dose escalation and expansion method, potentially allowing for more personalized treatment plans that optimize efficacy while minimizing side effects. This innovative strategy may lead to better outcomes by targeting cancer cells more precisely, offering a promising alternative to conventional therapies.

What evidence suggests that DSB2455 might be an effective treatment for cancer?

Research has shown that DSB2455, the investigational treatment in this trial, is promising because it blocks PARP1, a protein that helps cancer cells repair damaged DNA. Early lab studies found that DSB2455 is safe and effective. By targeting PARP1, DSB2455 aims to prevent cancer cells from repairing themselves, potentially shrinking tumors. This focused approach may enhance effectiveness while reducing side effects. Although these findings are preliminary, they suggest a hopeful path for cancer treatment.24567

Who Is on the Research Team?

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Johann de Bono, MB ChB FRCP

Principal Investigator

Institute of Cancer Research, United Kingdom

Are You a Good Fit for This Trial?

This trial is for adults with advanced brain, uterine, or other cancers who can provide a tissue sample and have measurable disease. They should be able to perform daily activities (ECOG 0-1), swallow pills, and have a life expectancy over 12 weeks. Participants must agree to follow the study plan and give blood samples for research.

Inclusion Criteria

I can swallow pills as they are.
My doctor expects me to live more than 12 weeks.
I have given my written consent to participate in the study.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Initial 2-stage inter-participant dose escalation to assess safety and tolerability of DSB2455

Variable duration

Dose Expansion

Participants receive DSB2455 to further assess safety, tolerability, and activity

Variable duration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DSB2455
Trial Overview DSB2455 is being tested in this study. It's an open-label trial with two parts: first, finding the right dose by increasing it between participants; second, giving that dose to more people to see how well it works and how safe it is.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: DSB2455 Dose Escalation & ExpansionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke Street Bio Ltd

Lead Sponsor

Trials
1
Recruited
90+

Citations

with DSB2455The first patient has been dosed in a Phase I trial evaluating the highly selective PARP1 inhibitor, DSB2455, in patients with solid tumours.
Study to Assess Safety, Tolerability and Activity of DSB2455 in ...Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness ...
Duke Street Bio Granted Approval by European Medicines ...By selectively inhibiting PARP1, we believe that DSB2455 has the potential to achieve a significantly enhanced therapeutic index, representing a ...
Duke Street Bio Receives EMA Approval for PARP1 ...Preliminary data from preclinical studies reveal that DSB2455 has a strong safety profile and exhibits compelling efficacy, encouraging the ...
Duke Street Bio receives FDA Fast Track designation for ...DSB2455 is a potentially best-in-class agent within the PARP1-selective inhibitor space, offering a differentiated profile that may expand therapeutic ...
NCT06458712 | Study to Assess Safety, Tolerability and ...Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.
Study to Assess Safety, Tolerability and Activity ...The Phase Ia/Ib trial is a multi-centre adaptively designed dose escalation study with expansion cohorts to assess the safety, tolerability, and activity of ...
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