Ovarian CancerPhase 1NCT05740956
A Study of Hansoh (HS)-10502 in Patients With Advanced Solid Tumors
A Phase 1 study testing HS-10502 in people with Ovarian Cancer and Breast Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
HS-10502 is a Poly(ADP-ribose) polymerase 1 (PARP1)-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 in subjects with homologous recombination repair (HRR) gene mutant or homologous recombination deficiency (HRD) positive… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ovarian Cancer, Breast Cancer, Pancreatic Cancer
- What is being tested?
- HS-10502
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2023to 1 Oct 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 18 - 75 years (inclusive).
- Having at least one target lesion per the RECIST v1.1.
- For the phase Ia Cohort A: advanced solid tumor carrying HRR gene mutation with failure or intolerance or not available to the currently available Standard of care (SoC).
- For the phase Ib study:
- Cohort B: patients with HRD positive recurrent ovarian cancer with failure or intolerance or not available to SoC Cohort C: patients with HRR gene mutation advanced Human epidermal growth factor receptor 2 (HER2)-negative breast cancer with failure or intolerance or not available to SoC Cohort D: patients with HRR gene mutation advanced pancreatic cancer with failure or intolerance or not available to SoC Cohort E: patients with HRR gene mutation mCRPC with failure or intolerance or not available to SoC Cohort F: patients with HRR gene mutation colorectal cancer with failure or intolerance or not available to SoC Cohort G: patients with other HRR gene mutation or HRD positive advanced solid tumors with failure or intolerance or not available to SoC
- Eastern cooperative oncology group (ECOG) performance status was 0-1.
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- Minimum life expectancy > 12 weeks.
- Females should be using adequate contraceptive measures and should not be breastfeeding Males should be using adequate contraceptive measures.
- Have signed Informed Consent Form.
Who cannot join
- Received or are receiving the following treatments:
- Previous or current treatment with two or more Poly(ADP-ribose) polymerase (PARP) inhibitors.
- Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment.
- Cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment; Nitrosourea or Mitomycin C within 6 weeks prior to the first dose of study treatment.
- Local radiotherapy within 2 weeks prior to the first dose of study treatment; more than 30% of bone marrow radiotherapy or large-area irradiation within 4 weeks before the first dose of study treatment.
- Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
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- Major surgery within 4 weeks prior to the first dose of study treatment.
- Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
- History of other primary malignancies.
- Known and untreated, or active central nervous system metastases.
- Inadequate bone marrow reserve or hepatic and renal functions.
- Myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML), or with features suggestive of MDS or AML.
- Severe, uncontrolled or active cardiovascular disorders.
- Diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months prior to the first dose of study treatment; glycosylated hemoglobin ≥ 7.5%.
- Serious or poorly controlled hypertension.
- Any life-threatening hemorrhagic event or events requiring blood transfusion within 120 days prior to the first dose of study treatment. Clinically significant hemorrhagic symptoms or obvious hemorrhagic tendency.
- Serious infection within 4 weeks prior to the first dose of study treatment, or presence of uncontrollable active infection in the screening period.
- Having serious neurological or mental disorders.
- A history of hypersensitivity to any of the active or inactive ingredients of HS-10502 or drugs with a similar chemical structure to HS-10502 or in the same class as HS-10502.
- Patients who may have poor compliance with the procedures and requirements of the study, as judged by the investigator.
- Patients with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.
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
Cancer Hospital Chinese Acedemy of Medical Sciences
Beijing, Beijing Municipality, 100020
Da Wei Wu
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10502 in Patients With Advanced Solid Tumors
HS-10502 is a Poly(ADP-ribose) polymerase 1 (PARP1)-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 in subjects with homologous recombination repair (HRR) gene mutant or homologous recombination deficiency (HRD) positive advanced solid tumors.
- Being tested
- HS-10502
- Keywords
- Poly(ADP-ribose) polymerase-1 inhibitor, HS-10502, Ovarian Cancer, Breast Cancer, Prostate Cancer, Colorectal Cancer
- Medical subject headings
- Ovarian Neoplasms, Breast Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10502Drug
HS-10502 will be administered once per day on a continuous dosing schedule starting on Cycle 1 Day 1 (C1D1) in a 28-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| HS-10502 | Experimental | HS-10502 Tablets，PO，QD Receives: Drug: HS-10502 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of HS-10502（Stage 1）
MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a Dose-limiting toxicity (DLT)
Measured: Cycle 1 (28 days)
Maximum applicable dose (MAD) of HS-10502（Stage 1）
MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the pharmacokinetics-pharmacodynamics (PK-PD) model, it suggested that the optimal target concentration of safety and efficacy has been explored
Measured: Cycle 1 (28 days)
Efficacy of HS-10502: Objective response rate (ORR)（Stage 2）
ORR is defined as the proportion of participants with Best Overall Response (BOR) of confirmed CR or confirmed PR per RECIST v1.1 (applicable for all solid tumors except prostate cancer) or per RECIST v1.1 and PCWG3 (for prostate cancer only)
Measured: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
Secondary outcomes (18)
[Stage 1 and Stage 2] Incidence and severity of treatment-emergent adverse events
Assessed by number and severity of adverse events as evaluated according to NCI CTCAE v5.0.
Measured: From Cycle 1 Day 1 (C1D1) until 28 days after the final dose. A cycle is 28 days
[Stage 1 and Stage 2] PK parameters: The maximum observed concentration (Cmax) of HS-10502
Maximum plasma drug concentration of HS-10502
Measured: Cycle 1 Day 1 (each cycle is 28 days)
[Stage 1 and Stage 2] PK parameters: time to Cmax (Tmax) of HS-10502
Time of maximum observed concentration of HS-10502
Measured: Cycle 1 Day 1 (each cycle is 28 days)
[Stage 1 and Stage 2] PK parameters: area under the concentration-time curve from time 0 to time t of last measurable concentration (AUC0-t) of HS-10502
Area under the curve from the time of dosing to the time of the last measurable (positive) concentration
Measured: Cycle 1 Day 1 (each cycle is 28 days)
[Stage 1 and Stage 2] PK parameters: Maximum plasma concentration at steady state (Css, max) of HS-10502
Maximum plasma drug concentration at steady state of HS-10502.
Measured: Cycle 2 Day 1 (each cycle is 28 days)
[Stage 1 and Stage 2] PK parameters: time to Css, max (Tss, max) of HS-10502
Time of maximum observed concentration at steady state of HS-10502
Measured: Cycle 2 Day 1 (each cycle is 28 days)
[Stage 1 and Stage 2] PK parameters: Minimum plasma concentration at steady state (Css, min) of HS-10502
Minimum plasma drug concentration at steady state of HS-10502
Measured: Cycle 2 Day 1 (each cycle is 28 days)
[Stage 1 and Stage 2] PK parameters: Area under the plasma concentration-time curve over a dosing interval at steady state (AUCss) of HS-10502
The partial area from dosing time to dosing time plus dosing interval of HS-10502
Measured: Cycle 2 Day 1 (each cycle is 28 days)
Efficacy of HS-10502: ORR
Proportion of participants with BOR of confirmed CR or confirmed Partial Response (PR) per RECIST v1.1 (applicable for all solid tumors except prostate cancer) or per RECIST v1.1 and The prostate cancer working group 3 criteria (PCWG3) (for prostate cancer only)
Measured: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
[Stage 1 and Stage 2] Efficacy of HS-10502: disease control rate (DCR)
P Percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 5 weeks) per RECIST v1.1 (applicable for all solid tumors except prostate cancer) or per RECIST v1.1 and PCWG3 (for prostate cancer only)
Measured: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
Title: [Stage 1 and Stage 2] Efficacy of HS-10502: duration of response (DoR)
DoR only applies to participants whose best overall response is CR or PR based on assessment per RECIST v1.1 (applicable for all solid tumors except prostate cancer) or per RECIST v1.1 and PCWG3 (for prostate cancer only). The start date is the date of first documented response of CR or PR (i.e. the start date of observed response, not the date when response was confirmed), and the end date is the date of the first documented progression or death due to underlying cancer.
Measured: From the date of CR, PR until the date of disease progression or withdrawal from study, approximately 2 years
[Stage 1 and Stage 2] Efficacy of HS-10502: progression free survival (PFS) (applicable for all solid tumors except prostate cancer)
Time from the date of randomization or first dose (if randomization is not needed) to the date of the first documented progression or death due to any cause. PFS will be assessed per RECIST v1.1.
Measured: From the date of randomization or first dose (if randomization is not needed) until the date of disease progression or withdrawal from study, approximately 2 years.
[Stage 1 and Stage 2] Efficacy of HS-10502: radiographic progression free survival (rPFS) (for prostate cancer only)
Time from the date of randomization or first dose (if randomization is not needed) to the date of the first documented progression or death due to any cause. rPFS will be assessed per RECIST v1.1 (soft tissue) and PCWG3 (bone).
Measured: From the date of randomization or first dose (if randomization is not needed) until the date of disease progression or withdrawal from study, approximately 2 years
[Stage 1 and Stage 2] Efficacy of HS-10502: ORR evaluated by RECIST v1.1 and Gynecologic Cancer Intergroup (GCIG) CA-125 (for ovarian cancer only)
Proportion of participants with BOR of confirmed CR or confirmed PR per both RECIST v1.1 and GCIG CA-125 criteria.
Measured: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
[Stage 2] Efficacy of HS-10502: overall survival (OS)
Time from the date of randomization or first dose (if randomization is not needed) to the date of death due to any cause. For each participant who is not known to have died as of the cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive
Measured: From the date of randomization or first dose (if randomization is not needed) until the documentation of death from any cause, approximately 4 years
[Stage 1 and Stage 2] Efficacy of HS-10502: Proportion of subjects with Carbohydrate antigen (CA)-125 decreased by ≥ 50% from baseline (for ovarian cancer only)
The percentage of subjects (ovarian cancer only) with a reduction of at least 50% from baseline in CA-125 levels.
Measured: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
[Stage 1 and Stage 2] Efficacy of HS-10502: ≥ 50% PSA decrease (PSA50) response rate (for prostate cancer only)
Proportion of subjects with a Prostate-specific antigen (PSA) nadir of ≤ 50% of baseline PSA level confirmed by serial PSA assessments (at least 3 weeks apart) after the start of the study.
Measured: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
[Stage 1 and Stage 2] Efficacy of HS-10502: Time to PSA progression (for prostate cancer only)
Time from the first dose to PSA progression based on PCWG3 criteria.
Measured: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start9 Jun 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The 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
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740956
- Sponsor's protocol ID
- HS-10502-101
- Status last verified
- Jun 2025
- First submitted
- 14 Feb 2023
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10502 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05740956
- Acronym / sponsor ID
- HS-10502-101
- Keywords
- Poly(ADP-ribose) polymerase-1 inhibitor, HS-10502, Ovarian Cancer, Breast Cancer, Prostate Cancer, Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 23 Feb 2023 (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-10502 is a Poly(ADP-ribose) polymerase 1 (PARP1)-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 in subjects with homologous recombination repair (HRR) gene mutant or homologous recombination deficiency (HRD) positive advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-10502 | Experimental | Drug: HS-10502HS-10502 Tablets，PO，QD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males or females aged 18 - 75 years (inclusive).
- Having at least one target lesion per the RECIST v1.1.
- For the phase Ia Cohort A: advanced solid tumor carrying HRR gene mutation with failure or intolerance or not available to the currently available Standard of care (SoC).
- For the phase Ib study:
- Cohort B: patients with HRD positive recurrent ovarian cancer with failure or intolerance or not available to SoC Cohort C: patients with HRR gene mutation advanced Human epidermal growth factor receptor 2 (HER2)-negative breast cancer with failure or intolerance or not available to SoC Cohort D: patients with HRR gene mutation advanced pancreatic cancer with failure or intolerance or not available to SoC Cohort E: patients with HRR gene mutation mCRPC with failure or intolerance or not available to SoC Cohort F: patients with HRR gene mutation colorectal cancer with failure or intolerance or not available to SoC Cohort G: patients with other HRR gene mutation or HRD positive advanced solid tumors with failure or intolerance or not available to SoC
Key exclusion criteria (21 listed)
- Received or are receiving the following treatments:
- Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
- History of other primary malignancies.
- Known and untreated, or active central nervous system metastases.
- Inadequate bone marrow reserve or hepatic and renal functions.
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-10502HS-10502 will be administered once per day on a continuous dosing schedule starting on Cycle 1 Day 1 (C1D1) in a 28-day treatment cycle. | Drug | HS-10502 |
Primary outcome
Maximum tolerated dose (MTD) of HS-10502（Stage 1）
Time frame: Cycle 1 (28 days)
MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a Dose-limiting toxicity (DLT)
Maximum applicable dose (MAD) of HS-10502（Stage 1）
Time frame: Cycle 1 (28 days)
MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the pharmacokinetics-pharmacodynamics (PK-PD) model, it suggested that the optimal target concentration of safety and efficacy has been explored
Efficacy of HS-10502: Objective response rate (ORR)（Stage 2）
Time frame: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
ORR is defined as the proportion of participants with Best Overall Response (BOR) of confirmed CR or confirmed PR per RECIST v1.1 (applicable for all solid tumors except prostate cancer) or per RECIST v1.1 and PCWG3 (for prostate cancer only)
18 secondary outcomes
[Stage 1 and Stage 2] Incidence and severity of treatment-emergent adverse events
Time frame: From Cycle 1 Day 1 (C1D1) until 28 days after the final dose. A cycle is 28 days
[Stage 1 and Stage 2] PK parameters: The maximum observed concentration (Cmax) of HS-10502
Time frame: Cycle 1 Day 1 (each cycle is 28 days)
[Stage 1 and Stage 2] PK parameters: time to Cmax (Tmax) of HS-10502
Time frame: Cycle 1 Day 1 (each cycle is 28 days)
[Stage 1 and Stage 2] PK parameters: area under the concentration-time curve from time 0 to time t of last measurable concentration (AUC0-t) of HS-10502
Time frame: Cycle 1 Day 1 (each cycle is 28 days)
[Stage 1 and Stage 2] PK parameters: Maximum plasma concentration at steady state (Css, max) of HS-10502
Time frame: Cycle 2 Day 1 (each cycle is 28 days)
[Stage 1 and Stage 2] PK parameters: time to Css, max (Tss, max) of HS-10502
Time frame: Cycle 2 Day 1 (each cycle is 28 days)
[Stage 1 and Stage 2] PK parameters: Minimum plasma concentration at steady state (Css, min) of HS-10502
Time frame: Cycle 2 Day 1 (each cycle is 28 days)
[Stage 1 and Stage 2] PK parameters: Area under the plasma concentration-time curve over a dosing interval at steady state (AUCss) of HS-10502
Time frame: Cycle 2 Day 1 (each cycle is 28 days)
Efficacy of HS-10502: ORR
Time frame: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
[Stage 1 and Stage 2] Efficacy of HS-10502: disease control rate (DCR)
Time frame: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
Title: [Stage 1 and Stage 2] Efficacy of HS-10502: duration of response (DoR)
Time frame: From the date of CR, PR until the date of disease progression or withdrawal from study, approximately 2 years
[Stage 1 and Stage 2] Efficacy of HS-10502: progression free survival (PFS) (applicable for all solid tumors except prostate cancer)
Time frame: From the date of randomization or first dose (if randomization is not needed) until the date of disease progression or withdrawal from study, approximately 2 years.
[Stage 1 and Stage 2] Efficacy of HS-10502: radiographic progression free survival (rPFS) (for prostate cancer only)
Time frame: From the date of randomization or first dose (if randomization is not needed) until the date of disease progression or withdrawal from study, approximately 2 years
[Stage 1 and Stage 2] Efficacy of HS-10502: ORR evaluated by RECIST v1.1 and Gynecologic Cancer Intergroup (GCIG) CA-125 (for ovarian cancer only)
Time frame: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
[Stage 2] Efficacy of HS-10502: overall survival (OS)
Time frame: From the date of randomization or first dose (if randomization is not needed) until the documentation of death from any cause, approximately 4 years
[Stage 1 and Stage 2] Efficacy of HS-10502: Proportion of subjects with Carbohydrate antigen (CA)-125 decreased by ≥ 50% from baseline (for ovarian cancer only)
Time frame: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
[Stage 1 and Stage 2] Efficacy of HS-10502: ≥ 50% PSA decrease (PSA50) response rate (for prostate cancer only)
Time frame: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
[Stage 1 and Stage 2] Efficacy of HS-10502: Time to PSA progression (for prostate cancer only)
Time frame: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
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 Jun 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-10502 in people with Ovarian Cancer and Breast Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. 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 9 inclusion and 21 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 Jun 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?
Contact Lingying Wu, Medical PhD (13910865483, wulingying@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) of HS-10502（Stage 1） (time frame: Cycle 1 (28 days)). The study lists 3 primary outcomes in all. 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 Jun 2025.