Status:
NOT_YET_RECRUITING
Phase I Study of HS-20108 in Participants With Advanced Solid Tumors
Lead Sponsor:
Hansoh BioMedical R&D Company
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I clinical study of HS-20108. The purpose of this study is to evaluate the safety, tolerability, PK and efficacy of intravenous HS-20108 in patients with advanced solid tumors.
Detailed Description
This is a multicenter, open-label Phase I clinical study to evaluate the safety, tolerability, PK and efficacy of intravenous HS-20108 in patients with advanced solid tumors. The study consists of Pha...
Eligibility Criteria
Inclusion
- Men or women aged more than or equal to (≥) 18 years.
- Participants with pathologically confirmed advanced solid tumors.
- At least one measurable lesion in accordance with RECIST 1.1
- Fresh or archival tumor tissue available for submission.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0\~1.
- Estimated life expectancy \>12 weeks.
- Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.
- Females must have evidence of non-childbearing potential.
- Signed and dated Informed Consent Form.
Exclusion
- Treatment with any of the following:
- Having received cytotoxic chemotherapy agents, investigational drugs, Chinese medicine treatment with anti-tumor indications, or other anti-tumor therapy (including endocrine therapy, molecular targeted therapy, or biotherapy) within 14 days before the first dose of study treatment.
- Having received macromolecular anti-tumor drug therapy (including immunotherapy, such as monoclonal antibody drugs and bispecific antibody drugs) within 28 days before the first dose of study treatment.
- Local radiotherapy for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.
- Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
- Inadequate bone marrow reserve or serious organ dysfunction.
- Uncontrolled pleural effusion or ascites or pericardial effusion.
- Known and untreated, or active central nervous system metastases.
- Active autoimmune diseases or active infectious disease
- Known to have interstitial pneumonia or immune pneumonia
- History of severe allergic reaction, serious transfusion reactions or Allergy to any component of HS-20108
- The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator.
- The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator.
- Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study.
- History of neuropathy or mental disorders, including epilepsy and dementia.
Key Trial Info
Start Date :
April 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 27 2027
Estimated Enrollment :
502 Patients enrolled
Trial Details
Trial ID
NCT06936735
Start Date
April 17 2025
End Date
November 27 2027
Last Update
April 20 2025
Active Locations (1)
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1
Jilin Cancer Hospital
Jilin, Jilin, China, 130000