DS9051b for Adrenal and Prostate Cancer

Recruiting at 11 trial locations

Overseen By Daiichi Sankyo Contact for Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Daiichi Sankyo

Must be taking: ARPI therapy

Must not be taking: Corticosteroids, Anticonvulsants

Disqualifiers: Pituitary dysfunction, Autoimmune, Cardiovascular, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 50 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DS9051b for individuals with advanced adrenal or prostate cancer that has spread. The main goal is to determine if DS9051b is safe and shows any early signs of effectiveness in treating these cancers. Individuals diagnosed with adrenal or prostate cancer that no longer responds to hormone therapy and have tried other treatments might be suitable candidates for this trial. Participants must be able to swallow tablets and have no other major health issues that could interfere with the trial. 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 treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or have certain medical conditions, you may need to adjust your treatment. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that DS9051b is likely to be safe for humans?

Research shows that DS9051b is a new treatment under testing for certain advanced cancers, such as adrenocortical carcinoma and prostate cancer. This study is in its first phase, focusing primarily on the safety and tolerability of DS9051b. Due to the early stage, information on patient responses remains limited. However, researchers closely monitor for any side effects or issues. This step is crucial to ensure the treatment's safety before advancing to further testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about DS9051b because it offers a novel approach for treating advanced or metastatic adrenocortical carcinoma and metastatic castration-resistant prostate cancer. Unlike current treatments, which often include chemotherapy and hormone therapy, DS9051b targets the cancer cells in a new way, potentially offering a more effective solution with fewer side effects. Its unique mechanism of action gives hope for better outcomes where existing therapies might fall short. This innovative approach is what makes DS9051b stand out as a promising option in the fight against these challenging cancers.

What evidence suggests that DS9051b might be an effective treatment for adrenal and prostate cancer?

Research is investigating DS9051b as a new treatment for difficult-to-treat cancers, such as adrenocortical carcinoma and metastatic castration-resistant prostate cancer. Participants in this trial will receive DS9051b. Although limited data from human trials exist, this drug targets specific parts of cancer cells, potentially stopping their growth. Early signs from studies suggest that DS9051b could be effective by interfering with cancer cell functions. This treatment aims to offer hope by directly addressing cancer growth. More information will become available as research progresses. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with advanced or metastatic adrenocortical carcinoma (ACC) or castration-resistant prostate cancer (mCRPC), who have tried at least one chemotherapy line. Participants must be able to swallow tablets, not have significant heart disease, uncontrolled autoimmune diseases, active infections that contraindicate steroids, CNS metastases requiring treatment, or unresolved toxicities from prior cancer therapy.

Inclusion Criteria

Sign and date the main ICF, prior to the start of any trial-specific procedures

I have had chemotherapy or cannot have or refused it.

I am 18 years old or older.

Exclusion Criteria

History of pituitary gland dysfunction

Participants who cannot swallow whole DS9051b tablets and/or follow DS9051b administration schedule at protocol-defined frequency due to some reasons (eg, dysphagia etc)

I am receiving treatment for an active or uncontrolled autoimmune disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE), and establish the safety profile of DS9051b

Up to 50 months

Treatment

Participants receive DS9051b and are monitored for dose-limiting toxicities and treatment-emergent adverse events

Up to 50 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DS9051b

Trial Overview The trial is testing DS9051b's safety and effectiveness in patients with ACC and mCRPC. It's a first-in-human study meaning it's the first time this drug is being tested in people for these conditions.

How Is the Trial Designed?

Group I: DS9051b Experimental Treatment 1 Intervention

Participants with advanced or metastatic adrenocortical carcinoma and metastatic castration-resistant prostate cancer who will receive DS9051b.

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07189403

NCT07189403 | A Study of DS9051b in Participants With ... Participants with advanced or metastatic adrenocortical carcinoma and metastatic castration-resistant prostate cancer who will receive DS9051b.

2. tipranks.com tipranks.com/news/company-announcements/daiichi-sankyos-new-study-on-ds9051b-a-potential-game-changer-in-cancer-treatment

Daiichi Sankyo's New Study on DS9051b: A Potential ... The study aims to evaluate the safety, tolerability, and preliminary efficacy of DS9051b, a promising new treatment for these challenging cancer ...

3. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07189403

DS9051b in Metastatic Castration-resistant Prostate Cancer ... This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and ...

4. go.drugbank.com go.drugbank.com/conditions/DBCOND0069854

Metastatic Castration-Resistant Prostate Cancer (mCRPC) ... A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer. DS9051b.

5. asco.org asco.org/abstracts-presentations/ABSTRACT323749

Survival outcomes in patients with metastatic castration ... Results: The study included 1395 mCSPC men of which 874 (63%) were ADT only, 338 (24%) were ADT+AA (98% with bicalutamide), 75 (5%) were ADT+ABI, and 108 (8%) ...

6. withpower.com withpower.com/trial/phase-1-adrenocortical-carcinoma-9-2025-c74e3

DS9051b for Adrenal and Prostate Cancer This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC. Show more. Are ...

7. ctv.veeva.com ctv.veeva.com/study/a-study-of-ds9051b-in-participants-with-advanced-or-metastatic-adrenocortical-carcinoma-and-metastat

A Study of DS9051b in Participants With Advanced or ... This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and ...