A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

Phase 1RecruitingNCT06830850

Atridia Pty Ltd.25 enrolled

Overview

To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Castration Resistant Prostate Cancer

Interventions

HRS-5041 Single dose of HRS-5041 orally administeredDRUG

HRS-5041 Oral dosage (Tablet) Oral dosage administration, 28 days per cycle.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

IInclusion Criteria 1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial. 2. Adequate bone marrow and other vital organ functions 3. Adequate liver function tests 4. Metastatic Castration-resistant Prostate Cancer Exclusion Criteria 1. Plan to receive any other anti-tumor therapy during the study. 2. Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study. 3. Uncontrolled hypertension (systolic blood pressure \[SBP\] \> 150 mmHg and/or diastolic blood pressure \[DBP\] \> 100 mmHg with regular anti-hypertension therapy). 4. Factors that may affect the oral administration of the IP (swallow difficulty, chronic diarrhea, and bowel obstruction, etc.), or active gastrointestinal (GI) disease or other disease which may affect the absorption, distribution, metabolism, or elimination of IP. 5. Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.). 6. Active heart disease within 6 months prior to the first dosing of this study. 7. Medical history of other malignant tumor within 5 years prior to dosing. 8. Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV-Ab), or syphilis or severe infections which need treatment.

Locations (11)

GenesisCare North Shore (Oncology)

Sydney, New South Wales, Australia

RECRUITING

Sydney Adventist Hospital

Sydney, New South Wales, Australia

RECRUITING

Outcomes

Primary Outcomes

Incidence and severity of adverse events, ECOG PS score, vital signs (pulse rate, respiratory rate, blood pressure, body temperature), ECG, clinical chemistry, hematology, urinalysis and physical examination

To evaluate the safety and tolerability profile of HRS-5041 in subjects with mCRPC.

Time frame: Screening up to study completion, an average of 1 year.

Secondary Outcomes

Concentration

Plasma concentrations of HRS-5041 during multiple dosing, directly observed from data

Time frame: Screening up to study completion,an average of 1 year.

Cmax,ss

Css, max are steady-state maximum concentrations of HRS-5041during multiple dosing, and are directly observed from data.

Time frame: From administration to C2, up to 4 months.

Cmin,ss

Css, min are the steady-state trough concentrations of HRS-5041 during multiple dosing, and are directly observed from data

Time frame: From administration to C2, up to 4 months.

Objective Response Rate (ORR)

ORR refers to the proportion of subjects with a complete response (CR) or partial response (PR) based on all soft tissue assessments recorded from the date of first drug administration to either the date of radiographic disease progression (including bone progression and soft tissue progression), death from any cause, or the initiation of a new antitumor therapy, whichever occurs first. For subjects with CR or PR at the first evaluation, the efficacy should be confirmed 4 weeks later or at the next tumor imaging evaluation. The numerator includes subjects with a confirmed CR/PR at least 4 weeks after the initial assessment. The denominator consists of subjects with measurable target lesions at baseline.

Time frame: Screening up to study completion, an average of 2 years.

Central Contacts

Kathy You

CONTACT

+61 02 9299 0433 kathyyou@atridia.com

Ravi Patel

CONTACT

+61 452 363 506 ravi.patel@atridia.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Cancer Research SA

Adelaide, South Australia, Australia

RECRUITING

Southern Oncology Clinical Research Unit

Adelaide, South Australia, Australia

RECRUITING

Icon Cancer Centre South Brisbane

Brisbane, Australia

RECRUITING

John Flynn Private Hospital

Brisbane, Australia

RECRUITING

Eastern Health (Box Hill Hospital)

Melbourne, Australia

RECRUITING

Linear Clinical Research Ltd

Perth, Australia

RECRUITING

Macquarie University

Sydney, Australia

RECRUITING

MUPharm Pty Limited trading as Macquarie University Hospital Pharmacy

Sydney, Australia

RECRUITING

...and 1 more locations

Best of Response (DoR)

Best of Response (DoR) BOR refers to the best response of tumor evaluation, including CR, PR, stable disease (SD), progressive disease (PD), and not evaluable for response (NE).

Time frame: Screening up to study completion, an average of 2 years.

Disease Control Rate (DCR)

Disease Control Rate (DCR) DCR refers to the time from the first occurrence of CR or PR to PD or death from any cause, whichever occurs first, in subjects with objective response. For subjects who have a confirmed CR or PR, DoR is calculated as the time from the date of first assessment confirming CR or PR to the date of first recorded radiographic disease progression or death from any cause, whichever occurs first. If the subject does not experience PD or death or is lost to follow-up at the end of study, DoR will be censored at the time of the last tumor evaluation.

Time frame: Screening up to study completion, an average of 2 years.

rPFS (radiographic progression-free survival

rPFS refers to the time from the first dose of investigational drug to the first radiographic PD or death from any cause (whichever occurs first) as assessed by the investigator. Radiographic disease progression includes both bone progression (based on PCWG3 criteria) and soft tissue progression (based on RECIST v1.1 criteria), with either type of progression counting as progression.

Time frame: Screening up to study completion, an average of 2 years.

PSA Response Rate at the end of Week 12

Refers to proportion of subjects with a ≥50% decline in serum PSA levels from baseline (PSA50) at the end of 12 weeks of study treatment.

Time frame: Screening up to the end of Week 12 , up to 4 months.

Proportion of Subjects with PSA50 (≥ 50% decline in serum PSA from baseline)

Refers to proportion of subjects with a ≥50% decline in serum PSA levels from baseline (PSA50) throughout the study treatment period.

Time frame: Screening up to the end of treatment, an average of 1 year.

Proportion of Subjects with PSA30 (≥ 30% decline in serum PSA from baseline)

Refers to proportion of subjects with a ≥30% decline in serum PSA levels from baseline (PSA30) throughout the study treatment period.

Time frame: Screening up to the end of treatment, an average of 1 year.

Time to PSA Progression

Refers to time from the date of first drug administration to the date of first PSA progression. PSA progression is determined based on PCWG3 criteria.

Time frame: From the date of first drug administration to the date of first PSA progression, an average of 1 year.

Overall Survival (OS)

OS refers to the time from the date of first drug administration to the date of death from any cause. From the date of first drug administration to the date of death from any cause.

Time frame: From the date of first drug administration to the date of death from any cause, an average of 2 year.