DS9051b for Adrenal and Prostate Cancer

Recruiting at 5 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 FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC.

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