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

Launched by JIANGSU HANSOH PHARMACEUTICAL CO., LTD. · Feb 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HS-10502 for patients with advanced solid tumors, including ovarian, breast, pancreatic, prostatic, and colorectal cancers. HS-10502 is designed to target specific genetic changes in tumors that can affect how they repair themselves. The main goals of the study are to determine how safe the treatment is, how well it works, and how it moves through the body.

To participate in this trial, patients need to be between 18 and 75 years old, have a specific type of tumor with certain genetic mutations, and have already tried other treatments that didn’t work or caused intolerable side effects. Participants will receive HS-10502 and will be closely monitored for any side effects and how well the treatment is working. It’s important for potential participants to discuss with their doctor whether they meet the eligibility criteria and to understand the commitment involved in being part of this study.

Gender

ALL

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.