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

Korábbi kezelés

• 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.

Más betegség

• 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.

Laborértékek

• Diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months prior to the first dose of study treatment; glycosylated hemoglobin ≥ 7.5%.

Egyéb

• 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.

• 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.