A Study of Hansoh (HS)-10502 in Patients With Advanced Solid Tumors

NCT ID: NCT05740956

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-09
• Study Completion Date: 2026-10-01

Brief 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 advanced solid tumors.

Conditions

Ovarian Cancer; Breast Cancer; Pancreatic Cancer; Prostatic Cancer; Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HS-10502

HS-10502 Tablets，PO，QD

Group Type: EXPERIMENTAL

HS-10502

Intervention Type: DRUG

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.

Interventions

HS-10502

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Hospital Chinese Acedemy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lingying Wu, Medical PhD

Role: CONTACT

wulingying@csco.org.cn

13910865483

Facility Contacts

Da Wei Wu

Role: primary

Other Identifiers

HS-10502-101

Identifier Type: -

Identifier Source: org_study_id