Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 75

Testing HS-10502 for advanced solid tumors

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

Run by Jiangsu Hansoh Pharmaceutical Co., Ltd. · NCT05740956 · Data updated 2026-11-12

This study is testing a new drug called HS-10502 to see if it can help people with advanced solid tumors that have certain genetic mutations and who haven't had success with standard treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment318 (estimated)
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
Industry-sponsored
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedJune 9, 2023
Main results expectedApril 1, 2026
Study endsOctober 1, 2026
Registry record updatedJune 5, 2025
Trial IDNCT05740956 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18-75 with advanced solid tumors carrying HRR gene mutations or HRD positivity who have failed or cannot tolerate standard treatments.

Probably not a fit

Patients with solid tumors that do not have HRR gene mutations or HRD positivity may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates HS-10502, a selective inhibitor of Poly(ADP-ribose) polymerase 1 (PARP1), in patients with advanced solid tumors that have specific genetic mutations. The trial aims to assess the safety, tolerability, pharmacokinetics, and efficacy of the drug in individuals with homologous recombination repair (HRR) gene mutations or homologous recombination deficiency (HRD). Participants will be grouped based on their cancer type and treatment history, specifically those who have not responded to or cannot tolerate standard treatments.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are resistant to current therapies.

How similar studies have gone: Other studies involving PARP inhibitors have shown promising results in similar patient populations, indicating potential for success with this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Males or females aged 18 - 75 years (inclusive).
2. Having at least one target lesion per the RECIST v1.1.
3. 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).
4. 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
5. Eastern cooperative oncology group (ECOG) performance status was 0-1.
6. Minimum life expectancy \> 12 weeks.
7. Females should be using adequate contraceptive measures and should not be breastfeeding Males should be using adequate contraceptive measures.
8. Have signed Informed Consent Form.

Exclusion Criteria:

1. Received or are receiving the following treatments:

   1. Previous or current treatment with two or more Poly(ADP-ribose) polymerase (PARP) inhibitors.
   2. Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment.
   3. 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.
   4. 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.
   5. Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
   6. Major surgery within 4 weeks prior to the first dose of study treatment.
2. Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
3. History of other primary malignancies.
4. Known and untreated, or active central nervous system metastases.
5. Inadequate bone marrow reserve or hepatic and renal functions.
6. Myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML), or with features suggestive of MDS or AML.
7. Severe, uncontrolled or active cardiovascular disorders.
8. Diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months prior to the first dose of study treatment; glycosylated hemoglobin ≥ 7.5%.
9. Serious or poorly controlled hypertension.
10. 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.
11. Serious infection within 4 weeks prior to the first dose of study treatment, or presence of uncontrollable active infection in the screening period.
12. Having serious neurological or mental disorders.
13. 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.
14. Patients who may have poor compliance with the procedures and requirements of the study, as judged by the investigator.
15. Patients with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.

Where it's running

  • Cancer Hospital Chinese Acedemy of Medical Sciences
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.