Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • XNW5004 1200 mg BID in Combination with Abiraterone plus Prednisone

    Drug

    Ib Cohort 1: XNW5004 1200 mg, PO, BID (10-14 hours interval between two doses, taken with warm water); Abiraterone 1000 mg PO, taken on an empty stomach at least 1 hour before and at least 2 hours after a meal, QD; Prednisone 5 mg PO, BID (prednisone dosing frequency may be adjusted at the investigator's discretion).

  • XNW5004 1200 mg BID in Combination with Docetaxel plus Prednisone

    Drug

    Ib Cohort 2: XNW5004 1200 mg, PO, BID (10-14 hours interval between two doses, taken with warm water), administered continuously until disease progression, death, withdrawal of informed consent, intolerable toxicity, or any other condition that the investigator deems necessary for study discontinuation. Docetaxel 75 mg/m², intravenous (IV), Day 1; Prednisone tablets 5 mg, PO, BID, taken continuously.

  • 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

    Drug

    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 or QD. Required first-dose sequence on Day 1 and Day 28 of Cycle 1 for the first 10 participants in each dose cohort: Take abiraterone first; consume a meal 1 hour after abiraterone administration; take XNW5004 tablets plus prednisone simultaneously 1.5 hours after abiraterone administration.

  • 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

    Drug

    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, QD. Required first-dose sequence on Day 1 and Day 28 of Cycle 1 for the first 10 participants in each dose cohort: Take abiraterone first; consume a meal 1 hour after abiraterone administration; take XNW5004 tablets plus prednisone simultaneously 1.5 hours after abiraterone administration.

  • XNW5004 800/1200 mg BID in Combination with Docetaxel plus Prednisone

    Drug

    XNW5004 800 mg or 1200 mg (1:1 randomization), PO, BID, administered continuously until disease progression, death, withdrawal of informed consent, intolerable toxicity, or any other condition that the investigator deems necessary for study discontinuation. Docetaxel 75 mg/m², intravenous (IV), Day 1 (premedication prior to docetaxel administration shall follow the prescribing information and standard clinical practice of the study center); plus Prednisone tablets 5 mg, PO, BID, taken continuously.

  • 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.

    Drug

    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.

    Drug

    Subsequent development plans will be determined based on preliminary study results.

Treatment groups

242 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: mCRPC (Prior NHT Failure Excluding Abiraterone) - XNW5004 + Abiraterone + PrednisoneExperimental treatment 1 intervention
Group B: mCRPC with Prior NHT Failure - XNW5004 + Docetaxel + PrednisoneExperimental treatment 1 intervention
Group C: Randomized mCRPC (Prior NHT Failure Excluding Abiraterone) - XNW5004 + Abiraterone + PrednisoneActive comparator 1 intervention
Group D: mCSPCActive comparator 1 intervention
Group E: Randomized mCRPC (Prior NHT Failure) - XNW5004 + Docetaxel + PrednisoneActive comparator 1 intervention
Group F: mCSPC Treated with XNW5004 in Combination with EnzalutamideExperimental treatment 1 intervention
Group G: XNW5004 + Anti-Tumor TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Radiographic Progression-Free Survival

Time frame
24months
2

Recommended Phase 3 Dose（Phase II Cohorts 1, 2, and 3）

Time frame
24 months

Secondary outcomes

1

Time to PSA Progression

Time frame
24 months
2

PSA Response Rate at Week 12

Time frame
24 months
3

Proportion of Participants with PSA Reduction ≥50% from Baseline During Entire Treatment Period

Time frame
24 months
4

Time to First Symptomatic Skeletal Event

Time frame
24 months

Other outcomes

1

Retrospective Analysis of Correlation Between Biomarkers (Including AR-V7) and Efficacy

Time frame
24 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Evopoint Biosciences Inc.

Lead sponsor

Source ClinicalTrials.gov

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