Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07365995
Eligibility Criteria:
Key Inclusion Criteria:
* Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent).
* Must have documented progressive prostate cancer based on at least one of the following criteria:
* Serum/plasma PSA progression, by local laboratory, defined as two consecutive increases in PSA over a previous reference value, each measured sequentially at least 1 week apart. The PSA value at screening is required to be ≥1.0 ng/mL.
* Radiographic soft tissue progression as per PCWG3-modified RECIST v1.1.
* Radiographic progression of bone disease: evaluable disease or new bone lesion(s) by bone scan per PCWG3 criteria.
* Had previously received one or two prior androgen receptor pathway inhibitor treatments and experienced disease progression during or after a minimum of 8 weeks of therapy.
* Must not have received systemic cytotoxic chemotherapy, including taxane-based chemotherapy, for mCRPC.
* Must have had prior orchiectomy and/or have ongoing androgen-deprivation therapy and a castrate-level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L). Participant being treated with luteinizing hormone-releasing hormone agonists or antagonists must continue such treatment throughout the study.
* Must have an Eastern Cooperative Oncology Group performance score of 0 or 1.
Key Exclusion Criteria:
* Have received prior treatment with B7-H3 targeted therapy, including B7-H3 ADCs.
* Have uncontrolled or significant cardiovascular disease, as defined in the protocol.
* Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or have current ILD/pneumonitis.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07365995
Study Brief:
Protocol Section:
NCT07365995