NCT06830850

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
10mo left

Started Jun 2025

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jun 2025Mar 2027

First Submitted

Initial submission to the registry

February 12, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

June 15, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2027

Last Updated

January 15, 2026

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

February 12, 2025

Last Update Submit

January 13, 2026

Conditions

Metastatic Castration Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (12)

  • Concentration

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

  • Cmax,ss

    From administration to C2, up to 4 months.

  • Cmin,ss

    From administration to C2, up to 4 months.

  • Objective Response Rate (ORR)

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

  • Best of Response (DoR)

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

  • +7 more secondary outcomes

Study Arms (1)

: HRS-5041 dose level 1

EXPERIMENTAL

240 mg BID

Drug: HRS-5041 Single dose of HRS-5041 orally administered

Interventions

HRS-5041 Single dose of HRS-5041 orally administeredDRUG

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

: HRS-5041 dose level 1

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
  • Adequate bone marrow and other vital organ functions
  • Adequate liver function tests
  • Metastatic Castration-resistant Prostate Cancer

You may not qualify if:

  • Plan to receive any other anti-tumor therapy during the study.
  • Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study.
  • Uncontrolled hypertension (systolic blood pressure \[SBP\] \> 150 mmHg and/or diastolic blood pressure \[DBP\] \> 100 mmHg with regular anti-hypertension therapy).
  • 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.
  • Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.).
  • Active heart disease within 6 months prior to the first dosing of this study.
  • Medical history of other malignant tumor within 5 years prior to dosing.
  • Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV-Ab), or syphilis or severe infections which need treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

GenesisCare North Shore (Oncology)

Sydney, New South Wales, Australia

RECRUITING

Sydney Adventist Hospital

Sydney, New South Wales, Australia

RECRUITING

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

Illawarra Shoalhaven Local Health District (Wollongong Hospital)

Wollongong, Australia

RECRUITING

Central Study Contacts

Kathy You

CONTACT

+61 02 9299 0433kathyyou@atridia.com

Ravi Patel

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2025

First Posted

February 17, 2025

Study Start

June 15, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 15, 2027

Last Updated

January 15, 2026

Record last verified: 2025-07

Locations

AU(11)