Clinical trial NCT06830850: 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
Official title: A Phase I, Open-label, Multi-Center, Non-Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Metastatic Castration Resistant Prostate Cancer
Lead sponsor: Atridia Pty Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-17
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Screening up to study completion, an average of 1 year.
Secondary outcomes:
measure: Concentration
timeFrame: Screening up to study completion,an average of 1 year.
measure: Cmax,ss
timeFrame: From administration to C2, up to 4 months.
measure: Cmin,ss
timeFrame: From administration to C2, up to 4 months.
measure: Objective Response Rate (ORR)
timeFrame: Screening up to study completion, an average of 2 years.
measure: Best of Response (DoR)
timeFrame: Screening up to study completion, an average of 2 years.
measure: Disease Control Rate (DCR)
timeFrame: Screening up to study completion, an average of 2 years.
measure: rPFS (radiographic progression-free survival
timeFrame: Screening up to study completion, an average of 2 years.
measure: PSA Response Rate at the end of Week 12
timeFrame: Screening up to the end of Week 12 , up to 4 months.
measure: Proportion of Subjects with PSA50 (≥ 50% decline in serum PSA from baseline)
timeFrame: Screening up to the end of treatment, an average of 1 year.
measure: Proportion of Subjects with PSA30 (≥ 30% decline in serum PSA from baseline)
timeFrame: Screening up to the end of treatment, an average of 1 year.
measure: Time to PSA Progression
timeFrame: From the date of first drug administration to the date of first PSA progression, an average of 1 year.
measure: Overall Survival (OS)
timeFrame: From the date of first drug administration to the date of death from any cause, an average of 2 year.
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: GenesisCare North Shore (Oncology)
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Adventist Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Cancer Research SA
state: South Australia
city: Adelaide
country: Australia
facility: Southern Oncology Clinical Research Unit
state: South Australia
city: Brisbane
country: Australia
facility: Icon Cancer Centre South Brisbane
city: Brisbane
country: Australia
facility: John Flynn Private Hospital
city: Melbourne
country: Australia
facility: Eastern Health (Box Hill Hospital)
city: Perth
country: Australia
facility: Linear Clinical Research Ltd
city: Sydney
country: Australia
facility: Macquarie University
city: Sydney
country: Australia
facility: MUPharm Pty Limited trading as Macquarie University Hospital Pharmacy
city: Wollongong
country: Australia
facility: Illawarra Shoalhaven Local Health District (Wollongong Hospital)
Study officials:
References: