Advanced Prostate CancerPhase 1NCT07115446
Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer
A Phase 1 study testing HS-20093 and HRS-5041 in people with Advanced Prostate Cancer, run by Hansoh BioMedical R&D Company at 1 site in China.
Trial summary
HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. HRS-5041 is a Proteolysis Targeting Chimeras (PROTAC) targeting androgen receptors. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Prostate Cancer
- What is being tested?
- HS-20093 and HRS-5041
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 19 Aug 2025to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men greater than or equal to 18 years.
- Voluntarily to participate, Signed and dated Informed Consent Form.
- Patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed after at least one type of novel hormonal therapy (standard treatment).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
- Estimated life expectancy ≥ 12 weeks.
- Men should use adequate contraceptive measures throughout the study, up to 3 months after the last dose of HRS-5041 or 4.5 months after the last dose of HS-20093 (whichever is later).
Who cannot join
- Treatment with any of the following:
- Previous or current treatment with B7-H3 targeted therapy. b. Previous treatment with AR PROTAC. c. Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 21 days prior to the first scheduled dose of HS-20093+HRS-5041. d. brain metastases.
- Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
- History of other primary malignancies.
- Inadequate bone marrow reserve or organ dysfunction.
- Severe, uncontrolled or active cardiovascular diseases.
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- Severe or uncontrolled diabetes.
- The presence of active infectious diseases.
- Any known or suspected interstitial lung disease.
- History of serious neuropathy or mental disorders.
- History of severe hypersensitivity reaction, severe infusion reaction.
- Hypersensitivity to any ingredient of HS-20093.
- Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.
- Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Fudan University Shanghai Cancer Center, 021-34778299
About this study
Official title: A Phase Ib Study to Explore the Safety, Tolerability, and Pharmacokinetics of HS-20093 Combination With HRS-5041 in Patients With Advanced Prostate Cancer
HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. HRS-5041 is a Proteolysis Targeting Chimeras (PROTAC) targeting androgen receptors.
This is a phase Ib, open-label, multi-center study to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-20093 combination with HRS-5041 in patients with advanced prostate cancer.
- Conditions
- Advanced Prostate Cancer
- Being tested
- HS-20093, HRS-5041
- Keywords
- Advanced prostate cancer, B7H3, HS-20093
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20093Drug
Intravenous (IV) administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
HRS-5041Drug
HRS-5041 was given oral administration, QD, at a 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| HS-20093+HRS-5041 | Experimental | Participants will receive HS-20093 at RP2D and HRS-5041 at Dose1 or Dose2. Receives: Drug: HS-20093; Drug: HRS-5041 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) or Maximum Administrated dose (MAD)
Number of participants with dose limiting toxicity
Measured: 21 days from administration of the first dose (C1D1) in the dose escalation phase， assessed up to 24 months
Secondary outcomes (10)
To evaluate the incidence and severity of adverse events (AEs)
AE assessed by investigator exclusively related to subject's underlying disease or medical condition [graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0]. Any untoward medical occurrence in a participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc.
Measured: From the first dose(C1D1) up to 30 days after the last dose of HRS-5041 or 90 days after the last dose of HS-20093 (whichever is later)
To evaluate the maximum plasma concentration (Cmax)
Cmax will be obtained following administration of the first dose of HS-20093 during the first cycle
Measured: up to approximately 24 months
To evaluate the Time to reach maximum plasma concentration (Tmax)
Tmax will be obtained following administration of the first dose of HS-20093 during the first cycle
Measured: up to approximately 24 months
To evaluate the Area under plasma concentration versus time curve from zero to last sampling time (AUC)
Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration was no less than the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule
Measured: up to approximately 24 months
To evaluate the immunogenicity of HS-20093
Proportion of patients who are positive for anti-HS-20093 antibodies
Measured: up to approximately 24 months
To evaluate the ORR determined by investigators
Objective response rate (ORR) determined by IRC according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3 (PCWG3)
Measured: up to approximately 24 months
To evaluate the Disease control rate (DCR) determined by investigators according to RECIST 1.1 and PCWG3
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) [Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose]
Measured: up to approximately 24 months
To evaluate the Duration of response (DoR) determined by investigators according to RECIST 1.1 and PCWG3
DoR is defined as the period from the first occurrence of CR or PR to progressive disease (PD) or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used [Confirmed CR/PR assessment require at least one repeat (≥4 weeks)]
Measured: up to approximately 24 months
To evaluate the Prostate-specific Cancer Antigen (PSA) response rate（PSA30,PSA50,PSA90）
PSA response is defined as a ≥ 30%，≥ 50% ，≥ 90% decline in PSA from baseline with PSA confirmation ≥ 3 weeks after the first documented reduction
Measured: up to approximately 24 months
To evaluate the Time to PSA progression
In participants with a decrease in PSA from baseline: ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥ 3 weeks later. In participants with no decrease in PSA from baseline: ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline value after 12 weeks.
Measured: up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start19 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CancerStudies of the same condition, open and under way.
- More trials run by Hansoh BioMedical R&D CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115446
- Sponsor's protocol ID
- HS-20093-107
- Status last verified
- Nov 2025
- First submitted
- 4 Aug 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Explore the Safety, Tolerability, and Pharmacokinetics of HS-20093 Combination With HRS-5041 in Patients With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT07115446
- Acronym / sponsor ID
- HS-20093-107
- Conditions
- Advanced Prostate Cancer
- Keywords
- Advanced prostate cancer, B7H3, HS-20093
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. HRS-5041 is a Proteolysis Targeting Chimeras (PROTAC) targeting androgen receptors.
This is a phase Ib, open-label, multi-center study to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-20093 combination with HRS-5041 in patients with advanced prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-20093+HRS-5041 | Experimental | Drug: HS-20093, Drug: HRS-5041Participants will receive HS-20093 at RP2D and HRS-5041 at Dose1 or Dose2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men greater than or equal to 18 years.
- Voluntarily to participate, Signed and dated Informed Consent Form.
- Patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed after at least one type of novel hormonal therapy (standard treatment).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
- Estimated life expectancy ≥ 12 weeks.
Key exclusion criteria (14 listed)
- Treatment with any of the following:
- Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
- History of other primary malignancies.
- Inadequate bone marrow reserve or organ dysfunction.
- Severe, uncontrolled or active cardiovascular diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-20093Intravenous (IV) administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression. | Drug | HS-20093+HRS-5041 |
| HRS-5041HRS-5041 was given oral administration, QD, at a 21-day cycle. | Drug | HS-20093+HRS-5041 |
Primary outcome
To determine the maximum tolerated dose (MTD) or Maximum Administrated dose (MAD)
Time frame: 21 days from administration of the first dose (C1D1) in the dose escalation phase， assessed up to 24 months
Number of participants with dose limiting toxicity
10 secondary outcomes
To evaluate the incidence and severity of adverse events (AEs)
Time frame: From the first dose(C1D1) up to 30 days after the last dose of HRS-5041 or 90 days after the last dose of HS-20093 (whichever is later)
To evaluate the maximum plasma concentration (Cmax)
Time frame: up to approximately 24 months
To evaluate the Time to reach maximum plasma concentration (Tmax)
Time frame: up to approximately 24 months
To evaluate the Area under plasma concentration versus time curve from zero to last sampling time (AUC)
Time frame: up to approximately 24 months
To evaluate the immunogenicity of HS-20093
Time frame: up to approximately 24 months
To evaluate the ORR determined by investigators
Time frame: up to approximately 24 months
To evaluate the Disease control rate (DCR) determined by investigators according to RECIST 1.1 and PCWG3
Time frame: up to approximately 24 months
To evaluate the Duration of response (DoR) determined by investigators according to RECIST 1.1 and PCWG3
Time frame: up to approximately 24 months
To evaluate the Prostate-specific Cancer Antigen (PSA) response rate（PSA30,PSA50,PSA90）
Time frame: up to approximately 24 months
To evaluate the Time to PSA progression
Time frame: up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-20093 and HRS-5041 in people with Advanced Prostate Cancer, run by Hansoh BioMedical R&D Company at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the maximum tolerated dose (MTD) or Maximum Administrated dose (MAD) (time frame: 21 days from administration of the first dose (C1D1) in the dose escalation phase， assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.