Actively Recruiting
A Study of Hansoh (HS)-10502 in Patients With Advanced Solid Tumors
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2025-06-05
318
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Hansoh (HS)-10502 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 - 75 years (inclusive)
- At least one target lesion measurable by RECIST v1.1
- For Phase Ia Cohort A: advanced solid tumor with HRR gene mutation and failure, intolerance, or no access to standard care
- For Phase Ib Cohorts B-G: various advanced solid tumors with HRD positive or HRR gene mutation, failed or intolerant to standard care
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Minimum life expectancy greater than 12 weeks
- Females must use adequate contraception and not be breastfeeding; males must use adequate contraception
- Signed informed consent form
You will not qualify if you...
- Previous or current treatment with two or more PARP inhibitors
- Use of traditional Chinese medicine for tumors within 2 weeks before first dose
- Cytotoxic chemotherapy, investigational drugs, or other anti-tumor therapies within 3 weeks before first dose; Nitrosourea or Mitomycin C within 6 weeks before first dose
- Local radiotherapy within 2 weeks before first dose; more than 30% bone marrow or large-area irradiation within 4 weeks before first dose
- Presence of pleural effusion or ascites requiring intervention; pericardial effusion
- Major surgery within 4 weeks before first dose
- Grade 2 or higher toxicities from prior anti-tumor therapy
- History of other primary cancers
- Known untreated or active central nervous system metastases
- Inadequate bone marrow, liver, or kidney function
- Myelodysplastic syndromes or acute myeloid leukemia, or features suggesting these
- Severe, uncontrolled, or active cardiovascular diseases
- Diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months before first dose; HbA1c ≥ 7.5%
- Serious or uncontrolled hypertension
- Life-threatening bleeding events or blood transfusions within 120 days before first dose; significant bleeding symptoms
- Serious infection within 4 weeks before first dose or uncontrolled active infection during screening
- Serious neurological or mental disorders
- Hypersensitivity to HS-10502 or related drugs
- Poor compliance with study procedures as judged by investigator
- Any condition compromising patient safety or study assessments as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Acedemy of Medical Sciences
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
Research Team
L
Lingying Wu, Medical PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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