Testing HS-10502 for advanced solid tumors

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

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

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 318 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05740956 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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

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

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.

Where this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Study coordinator: Lingying Wu, Medical PhD

Conditions Ovarian Cancer; Breast Cancer; Pancreatic Cancer; Prostatic Cancer; Colorectal Cancer; Poly polymerase-1 inhibitor; HS-10502; Prostate Cancer, Colorectal Cancer