Study of XNW5004 Tablets in Advanced Prostate Cancer
ConditionAdvanced Prostate Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorEvopoint Biosciences Inc.
About this trial
Phase Ib A preliminary design of 2 cohorts is planned for this phase, with 3-6 participants to be enrolled in each cohort. A total of 6-12 participants with advanced prostate cancer are planned to be enrolled in this phase. The study will be conducted at multiple investigational sites.
Phase II A preliminary design of 5 cohorts is planned for this phase. Cohorts 1, 2, and 3 are preset with 2 dose groups each, and each dose group plans to enroll 20-30 participants. Cohort 4 plans to enroll 20-50 participants. Cohort 5 will be adjusted based on results from prior study phases. A total of 140-230 participants with advanced prostate cancer are planned to be enrolled in this phase. The study will be conducted at multiple investigational sites.
Eligibility criteria
Qualifiers
Signed written informed consent prior to initiation of any study activity/procedure;
Male, ≥18 years of age;
Expected survival ≥ 3 months;
ECOG performance status score of 0-1;
Disqualifiers
Cohort 1: Prior treatment with abiraterone or cytotoxic chemotherapy (including but not limited to antibody-drug conjugates [ADCs] with cytotoxic payload). *Note:* Docetaxel use during the hormone-sensitive setting is allowed, provided there was no treatment failure or disease progression during therapy or within 3 months after completion.
Cohort 2: Prior cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload) at any stage of prostate cancer. *Note:* Docetaxel use during the hormone-sensitive setting is allowed, provided there was no treatment failure or disease progression during therapy or within 3 months after completion.
Cohort 1: Prior treatment with abiraterone or cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload). *Note:* Docetaxel use during the hormone-sensitive setting is allowed, provided there was no treatment failure or disease progression during therapy or within 3 months after completion.
Cohort 2:Participants must be treatment-naïve in the metastatic castration-sensitive prostate cancer (mCSPC) setting; i.e., participants must not have received any cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload), with the exception that first-generation antiandrogen (ADT) therapy is allowed during the mCSPC stage.
Trial design
Treatments tested in this trial
- XNW5004 1200 mg BID in Combination with Abiraterone plus Prednisone
- XNW5004 1200 mg BID in Combination with Docetaxel plus Prednisone
- XNW5004 800 mg or 1200 mg (1:1 randomization), PO, BID; Abiraterone 1000 mg PO, taken on an empty stomach at least 1 hour before and at least 2 hours after a meal, QD; plus Prednisone 5 mg PO BID
- XNW5004 800 mg or 1200 mg (1:1 randomization), PO, BID; Abiraterone 1000 mg PO, taken on an empty stomach at least 1 hour before and at least 2 hours after a meal, QD; plus Prednisone 5 mg PO, QDD
- XNW5004 800/1200 mg BID in Combination with Docetaxel plus Prednisone
- XNW5004 1200 mg, PO, BID (10-14 hours interval between two doses, taken with warm water); Enzalutamide 160 mg, PO, QD. Each treatment cycle consists of 4 weeks.
- Subsequent development plans will be determined based on preliminary study results.
Treatment groups
242 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
Source ClinicalTrials.gov