Tests HS-10502 in advanced solid tumors with DNA repair gene changes
Tests HS-10502, a PARP1 inhibitor, in adults with advanced solid tumors.
Plain-language title generated from the registry record
Registry title: A Study of Hansoh (HS)-10502 in Patients With Advanced Solid Tumors
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05740956, who can take part
Where in China
- Cancer Hospital Chinese Acedemy of Medical SciencesBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Trial code
- NCT05740956
- Record updated
- 5 June 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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; 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.
Exclusion: 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; Major surgery within 4 weeks prior to the first dose of study treatment; Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy; 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; History of other primary malignancies; Myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML), or with features suggestive of MDS or AML; Severe, uncontrolled or active cardiovascular disorders; Serious or poorly controlled hypertension; 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 with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator; Diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months prior to the first dose of study treatment; glycosylated hemoglobin ≥ 7.5%; Known and untreated, or active central nervous system metastases; Inadequate bone marrow reserve or hepatic and renal functions; Patients who may have poor compliance with the procedures and requirements of the study, as judged by the investigator.