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Recurrent Ovarian CancerPhase 1HS-10502NCT06769425

HS-10502 Combination Treatment in Patients With Advanced Solid Tumors

A Phase 1 study testing HS-10502 + NHA, HS-10502 + HS-20093 and HS-10502+ Apatinib in people with Recurrent Ovarian Cancer and HER2-negative, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

HS-10502 is a PARP1-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 Combination Treatment in subjects with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HS-10502 + NHA, HS-10502 + HS-20093 and HS-10502+ Apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
157 participants
Where
1 siteChina
Study dates
7 May 2025to 31 Aug 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females aged 18 years or older (≥18 years).
  • Patients diagnosed with pathologically confirmed advanced solid tumors.
  • Subjects have at least one target lesion as assessed per the RECIST 1.1.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no deterioration within 2 weeks before the first dose.
  • Have a life expectancy of at least 12 weeks.
  • Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent until 6 months after the last dose; male subjects must agree to use barrier contraception (i.e. condoms) from signing the informed consent to 6 months after the last dose.
  • Female subjects must have a negative pregnancy test within 7 days prior to the first dose (for subjects with tumor related abnormal elevation of human chorionic gonadotropin [HCG], an ultrasound of uterus and appendages should be performed within 7 days prior to the first dose to rule out pregnancy), or demonstrate no risk for pregnancy.
  • Subject must be voluntarily enrolled in this clinical trial, be able to understand the study procedures and to sign written informed consent.

Who cannot join

  • Have received or is currently receiving the following treatment: PARPi/B7-H4/B7-H3-targeted therapies;
  • Have received or is currently receiving the following treatment: PARPi/B7-H4/B7-H3-targeted therapies;
  • Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 14 days prior to the first dose of study drug; or need to continue these drugs during the study.
  • Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events due to prior anti-tumor therapy.
  • Presence of pleural/abdominal effusion requiring clinical intervention.
  • Known history of other primary malignancy.
Show all 25Show fewer
  • Evidence of brain metastasis and/or cancerous meningitis
  • Inadequate bone marrow reserve or hepatic/renal functions.
  • Cardiological examination abnormality.
  • Severe, uncontrolled or active cardiovascular disorders.
  • Serious or poorly controlled diabetes.
  • Serious or poorly controlled hypertension.
  • Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose of study treatment.
  • Serious infections within 4 weeks prior to the first dose.
  • Have received systemic glucocorticoid therapy for more than 7 days within 28 days prior to the first dose study treatment, or require chronic (≥ 7 days) use of systemic glucocorticoids during the study, or have other acquired, congenital immunodeficiency disorders, or a history of organ transplantation.
  • Presence of active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus infection, etc.
  • Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis.
  • Any moderate or severe lung diseases that may interfere with the detection and treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.
  • History of severe neurological or psychiatric disorder.
  • Pregnant or breast-feeding women or women who intend to become pregnant during the study.
  • Attenuated live vaccination within 4 weeks prior to the first dose.
  • Subjects with autoimmune disease that is active or is likely to recur.
  • Subjects with gastrointestinal fistula, visceral fistula, gastrointestinal perforation, or abdominal abscess, or with symptoms/signs of intestinal obstruction within 6 months prior to the first dose of study drug.
  • Subjects unlikely to comply with study procedures, restrictions and requirement as determined by the investigator.
  • Subjects 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.

Xi Yan contact

18721195312

yanx1@hspharm.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Ding Wei Ye, 13701663571, fuscc2012@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10502 Combination Treatment in Subjects With Advanced Solid Tumors

HS-10502 is a PARP1-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 Combination Treatment in subjects with advanced solid tumors.

Read the detailed description

This is a phase I, multicenter, open-label clinical study to evaluate the safety, tolerability, PK, and efficacy of oral HS-10502 combination treatment in subjects with advanced solid tumors. The study will be divided into phase Ia (dose escalation) and phase Ib (dose expansion). The dose-escalation study will be conducted to evaluate the safety, tolerability, PK profile, and efficacy, as well as to determine the maximum tolerable dosage (MTD) or maximum applicable dose (MAD) of HS-10502 in combination with other antitumor agents (Enzalutamide, Rezvilutamide,Abiraterone,HS-20093,Apatinib,HS-20089,Platinum,Bevacizumab,nab-paclitaxel,Docetaxel, Irinotecan) The subsequent dose expansion study will select appropriate target populations (7 cohorts of recurrent ovarian cancer, HER2-negative advanced breast cancer, TNBC, advanced prostate cancer , advanced gastric cancer and HRD positive advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer) based on the data obtained in the phase Ia study, and determine the recommended phase II dose (RP2D) for each target population.

Safety evaluation will be performed for all the subjects in each cycle of therapy (3 weeks or 2 weeks) until Cycle 16, and then once every 6 weeks, until 30 days or 90 days after the last dose. The PK characteristics of HS-10502 will be evaluated during screening period and study treatment. Efficacy evaluation will be performed once every 6 weeks after C1D1 until objective disease progression or withdrawal from the study. As the disease progresses, survival follow-up will be performed every 12 weeks from the last dose.

Being tested
HS-10502 + NHA, HS-10502 + HS-20093, HS-10502+ Apatinib, HS-10502 + HS-20089, HS-10502 + Platinum + Bevacizumab
Keywords
Poly(ADP-ribose) polymerase-1 inhibitor, HS-10502, ovarian cancer, breast cancer, TNBC, prostate cancer, gastric cancer
Medical subject headings
Ovarian Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-10502 + NHADrug

    HS-10502 + NHA

  • HS-10502 + HS-20093Drug

    HS-10502 + HS-20093

  • HS-10502+ ApatinibDrug

    HS-10502+ Apatinib

  • HS-10502 + HS-20089Drug

    HS-10502 + HS-20089

  • HS-10502 + Platinum + BevacizumabDrug

    HS-10502 + Platinum + Bevacizumab

  • HS-10502 + nab-paclitaxel or Docetaxel or IrinotecanDrug

    HS-10502 + nab-paclitaxel or Docetaxel or Irinotecan

  • HS-10502 + BevacizumabDrug

    HS-10502 + Bevacizumab

Study groups in NCT06769425
Study groupRoleWhat they receive
Cohort 1ExperimentalAdvanced prostate cancer
Receives: Drug: HS-10502 + NHA
Cohort 2ExperimentalAdvanced prostate cancer or solid tumor
Receives: Drug: HS-10502 + HS-20093
Cohort 3ExperimentalAdvanced HER2-negative breast cancer or recurrent ovarian cancer
Receives: Drug: HS-10502+ Apatinib
Cohort 4ExperimentalRecurrent ovarian cancer
Receives: Drug: HS-10502 + HS-20089
Cohort 5ExperimentalPlatinum-sensitive recurrent ovarian cancer
Receives: Drug: HS-10502 + Platinum + Bevacizumab
Cohort 6ExperimentalAdvanced gastric cancer or solid tumor
Receives: Drug: HS-10502 + nab-paclitaxel or Docetaxel or Irinotecan
Cohort 7ExperimentalHRD positive advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer
Receives: Drug: HS-10502 + Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) of HS-10502（Stage 1：Dose escalating stage）

    MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT.

    Measured: Cycle 1 (21 days)

  2. Maximum applicable dose (MAD) of HS-10502（Stage 1：Dose escalating stage）

    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 PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.

    Measured: Cycle 1 (21days)

  3. Efficacy of HS-10502: Objective response rate (ORR)（Stage 2： Dose expansion stage）

    ORR is defined as the proportion of participants with 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)

  1. 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 21 days after the final dose. A cycle is 21days.

  2. PK parameters: The maximum observed concentration (Cmax) of HS-10502

    Defines as the maximum plasma drug concentration of HS-10502

    Measured: Cycle 1 Day 1 (each cycle is 21 days)

  3. 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 21 days)

  4. 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 21 days)

  5. PK parameters: Maximum plasma concentration at steady state (Css, max) of HS-10502

    Defines as the maximum plasma drug concentration at steady state of HS-10502.

    Measured: Cycle 2 Day 1 (each cycle is 21 days)

  6. 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 21 days)

  7. 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 21 days)

  8. 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 21days)

  9. Efficacy of HS-10502: ORR

    ORR is defined as the proportion of participants with 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

  10. Efficacy of HS-10502: disease control rate (DCR)

    The disease control was defined as the 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

  11. 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 defined as 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

  12. Efficacy of HS-10502: progression free survival (PFS) (applicable for all solid tumors except prostate cancer)

    PFS is defined as the 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.

  13. Efficacy of HS-10502: radiographic progression free survival (rPFS) (for prostate cancer only)

    rPFS is defined as the 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.

  14. Efficacy of HS-10502: ORR evaluated by RECIST v1.1 and GCIG CA-125 (for ovarian cancer only)

    For ovarian cancer, ORR is defined as the 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

  15. Efficacy of HS-10502: overall survival (OS)

    OS is defined as the 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

  16. Efficacy of HS-10502: Proportion of subjects with 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

  17. Efficacy of HS-10502: PSA50 response rate (for prostate cancer only)

    PSA50 response rate is defined as the proportion of subjects with a 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

  18. Efficacy of HS-10502: Time to PSA progression (for prostate cancer only)

    Time to PSA progression is defined as the 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.

  1. First posted10 Jan 2025
  2. Study start7 May 2025
  3. Primary completion7 May 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
157 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06769425
Sponsor's protocol ID
HS-10502-103
Acronym
HS-10502
Status last verified
Jun 2025
First submitted
7 Jan 2025
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-10502 + NHA, HS-10502 + HS-20093 and HS-10502+ Apatinib in people with Recurrent Ovarian Cancer and HER2-negative, 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 8 inclusion and 25 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 24 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 Xi Yan (18721195312, yanx1@hspharm.com), 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：Dose escalating stage） (time frame: Cycle 1 (21 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?

On the ClinicalTrials.gov record for NCT06769425.

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 24 Jun 2025.

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