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Study of HRS-2189 Combined HRS-5041 in Prostate Cancer

ConditionProstate Cancer Metastatic Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-80
SponsorFudan University

About this trial

Our study is aimed to evaluate the efficacy and safety of HRS-2189 combined with HRS-5041 in metastatic prostate cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years to 80 years old (including boundary values), male subjects;

ECOG PS Score: 0~1;

Histologically or cytologically confirmed prostate adenocarcinoma, and no prior diagnosed as neuroendocrine carcinoma or small cell carcinoma;

Disease progression when enrolled in the study;

Disqualifiers

Known existence of CNS metastasis or meningeal metastasis, or known history of primary CNS tumor;

Severe bone injury caused by bone metastasis identified by investigators, including uncontrolled severe bone pain, pathological bone fracture at the important part and spinal cord compression having occurred for the last 6 months or expected to occur in the near future;

Existence of third space fluid that is not well controlled by effective methods, e.g. drainage;

Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy, immunological therapy or attenuated live vaccine within 4 weeks before first dose of study therapy (6-week washout period for bicalutamide);

Trial design

Design model

Single group

Treatments tested in this trial

  • HRS-2189

    Drug

    HRS-2189

  • HRS-5041

    Drug

    HRS-5041

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: HRS-2189 + HRS-5041Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

PSA50

PSA50 is the percentage of evaluable patients with ≥50% decline in PSA level, measured at baseline and the time point of every 4 weeks in efficacy analysis set.

Time frame
up to 2 years

Secondary outcomes

1

PSA30

PSA30 is the percentage of evaluable patients with ≥30% decline in PSA level measured at baseline and the time point of every 4 weeks in efficacy analysis set.

Time frame
up to 2 years
2

Time to PSA progression

The definition is the time from the date of first dose until the date of first PSA progression or death (by any cause in the absence of progression). PSA progression is per PCWG3 criteria and newest version of CSCO guideline as follows: 1) if PSA level declines from baseline, PSA level is ≥25% increase from baseline and ≥1 ng/ml, which needs to be confirmed after at least 4 weeks; 2) if PSA level has not declined from baseline, PSA level is ≥25% increase from baseline and ≥1 ng/ml after at least 12 weeks from the date of first dose.

Time frame
up to 2 years
3

ORR by investigator

ORR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1, and measured at baseline and the time point of every 8 weeks in first 16 weeks, at the time point of every 12 weeks after first 16 weeks.

Time frame
up to 2 years
4

DCR by investigator

DCR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response), PR (partial response) or SD (stable disease) per RECIST v1.1, and measured at baseline and the time point of every 8 weeks in first 16 weeks, at the time point of every 12 weeks after first 16 weeks.

Time frame
up to 2 years

Other outcomes

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: