A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorMediLink Therapeutics (Suzhou) Co., Ltd.
About this trial
This is a multicenter, open-label, phase II study of YL201 in China to evaluate the efficacy, safety, and PK characteristics of YL201 on mCRPC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects who understand relevant information of the study prior to initiation of the study and voluntarily sign and date on the ICF.
Age ≥ 18 years.
Histologically or cytologically confirmed prostate cancer. Note: The primary histological classification indicated by biopsy should be adenocarcinoma;
Subjects who understand relevant information of the study prior to initiation of the study and voluntarily sign and date on the ICF.
Disqualifiers
Previously treated with drugs targeting B7H3.
Currently participating in another clinical study, unless it is an observational (non-interventional) clinical study, or the patient is at the follow-up period of an interventional study.
Previously treated with topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.
The washout period of the previous anti-tumor therapy is considered insufficient.
Trial design
Design model
Single group
Treatments tested in this trial
YL201 for Injection
DrugPatients will be treated with YL201 intravenous (IV) infusion once every 3 weeks on Day 1 or twice every 3 weeks on Day 1 and Day 8 during a 3-week (21-day) cycle.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Part 1Experimental treatment 1 intervention
Group B: Part2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR) by RECIST1.1 and PCWG3 criteria per investigators' review
defined as percentage of participants with confirmed best overall response of confirmed complete response (CR) or partial response (PR) to treatment
Time frame
Approximately within 36 months2
Radiographic progression free survival (rPFS), and rPFS rate at 3/6 months by RECIST1.1 and PCWG3 criteria per investigators' review
defined as the time from the date of first administration to first documented progressive disease (PD) per RECIST1.1 and PCWG3 or death from any cause, whichever occurs first.
Time frame
Approximately within 36 months3
Recommended dose of YL201 for the pivotal clinical trial.
Time frame
Approximately within 36 monthsSecondary outcomes
1
disease control Rate (DCR) by RECIST1.1 and PCWG3 criteria per investigators' review
Disease control rate
Time frame
Approximately within 36 months2
To evaluate DoR by RECIST1.1 and PCWG3 criteria per investigators' review of YL201 in the treatment of mCRPC
Duration of rasponse
Time frame
Approximately within 36 months3
To evaluate TTR of YL201 in the treatment of mCRPC
Time to Objective response
Time frame
Approximately within 36 months4
To evaluate DpR of YL201 in the treatment of mCRPC
deepness of response
Time frame
Approximately within 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov