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New treatment option for Advanced or Metastatic Adrenocortical Carcinoma
Official title A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer
ClinicalTrials.gov ID: NCT07189403
What this study is testing
What is DS9051b?
DS9051b is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced or metastatic adrenocortical carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General for All Participants
- Sign and date the main ICF, prior to the start of any trial-specific procedures.
- Adults ≥18 years of age at the time the ICF is signed (Follow local regulatory requirements if the legal age of consent for trial participation is...
- Histologically confirmed diagnosis of ACC or adenocarcinoma of the prostate
- ECOG PS of 0 or 1 assessed no more than 14 days prior to C1D1. (ECOG PS of 2 due to cancer pain is acceptable)
See the full eligibility criteria
- General for All Participants
- Sign and date the main ICF, prior to the start of any trial-specific procedures.
- Adults ≥18 years of age at the time the ICF is signed (Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old)
- Histologically confirmed diagnosis of ACC or adenocarcinoma of the prostate
- ECOG PS of 0 or 1 assessed no more than 14 days prior to C1D1. (ECOG PS of 2 due to cancer pain is acceptable)
- Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to C1D1 as defined below. Organ and bone marrow function criteria must also be met when laboratory tests are repeated...
- Treatment with at least 1 line (or more) of ARPI therapy for CSPC or in CRPC for a minimum of 12 weeks (eg, abiraterone, enzalutamide, darolutamide, apalutamide).
- Treatment with at least 1 line (or more) of chemotherapy, having ineligibility for chemotherapy or refusal of chemotherapy.
- Documented disease progression by one or more of the following criteria:
- PSA progression as defined by PCWG3 criteria.
- Soft tissue disease progression as defined by RECIST 1.1 criteria.
- Bone disease progression as defined by Prostate Cancer Working Group 3 criteria. An individual who meets any of the following criteria will be excluded from participation in this trial:
- History of pituitary gland dysfunction.
- Active or uncontrolled autoimmune disease requiring systemic treatment.
- Any medical condition (other than the cancer disease) requiring a dose of concurrent systemic corticosteroid treatment greater than 5 mg of prednisone and/or 100 μg of fludrocortisone per day (or equivalent).
- Active infection or other medical conditions that would make corticosteroids contraindicated.
- Has spinal cord compression or clinically active central nervous system metastases, defined as untreated, clinically progressive, symptomatic, or requiring systemic therapy with corticosteroids or anticonvulsants or...
- Uncontrolled or significant cardiovascular disease.
- History of another primary malignancy (beyond the indication(s) under study) except for:
- Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of trial intervention and of low potential risk for recurrence.
- Non-melanoma skin cancer, lentigo maligna, or lentigo maligna melanoma treated with curative intent and without evidence of disease.
- Carcinoma in situ treated with curative intent and without evidence of disease.
- Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage ≤T2cN0M0 without biochemical recurrence or progression and who, in the opinion of the investigator, are not deemed to require active...
- Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE version 5.0, Grade ≤1 or baseline.
- Participants who cannot swallow whole DS9051b tablets and/or follow DS9051b administration schedule at protocol-defined frequency due to some reasons (eg, dysphagia etc).
- Known gastrointestinal disease or gastrointestinal procedure that may interfere with absorption of trial intervention including proton pump inhibitors and antacids.
The study team makes the final eligibility decision.
Where it's taking place
- Sarasota, Florida, United States
- New York, New York, United States
- Providence, Rhode Island, United States
- Toulouse, France
- Villejuif, France
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sarasota, Florida, United States; New York, New York, United States; Providence, Rhode Island, United States; Toulouse, France; Villejuif, France; London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.