Status:
NOT_YET_RECRUITING
Study of HS-20105 for Injection in Patients With Advanced Solid Tumors.
Lead Sponsor:
Hansoh BioMedical R&D Company
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
HS-20105 is a novel antibody-drug conjugate (ADC) targeting Trop-2. This first-in-human trial is aimed to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the phar...
Detailed Description
This is a multicenter, open-label Phase I clinical study evaluating the safety, tolerability, PK, and efficacy of HS-20105 in patients with advanced solid tumors. The study includes Phase Ia (dose esc...
Eligibility Criteria
Inclusion
- Men or women aged more than or equal to (≥) 18 years.
- Advanced solid tumor patients confirmed by histology or cytology for who that standard treatment is failed or intolerable.
- Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required). Patients with only brain and/or bone lesions as target lesions will not be included.
- Fresh or archived tumor tissue samples need to be provided (fresh samples are preferred, and tumor tissue samples within 2 years before the first administration can be accepted; the sample type is formalin fixed, paraffin embedded \[FFPE\] tumor tissue block or FFPE slides).
- ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks.
- Estimated life expectancy greater than (\>) 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 the evidence of non-childbearing potential.
- Sign informed consent form.
Exclusion
- Has received or is currently undergoing the following treatment:
- Previously or current treatment with drugs targeting Trop-2 or other ADC drugs conjugated with HS-9265;
- Received traditional Chinese medicine therapy with anti-tumor indications within 2 weeks prior to the first administration of HS-20105;
- Received cytotoxic chemotherapy drugs or other anti-tumor system therapies (including endocrine therapy, molecular targeted therapy, or biological therapy) within 3 weeks prior to the first administration of HS-20105;
- Received macromolecular anti-tumor drugs or experimental drug therapy within 4 weeks before the first administration of HS-20105;
- Received local radiotherapy within 2 weeks before the first administration of HS-20105; Received more than 30% of bone marrow irradiation or extensive radiation therapy within 4 weeks before the first administration of HS-20105;
- Received major surgery within 4 weeks before the first administration of HS-20105.
- Received strong inhibitors or inducers of CYP3A4, CYP2D6, P-gp or BCRP, or drugs with narrow treatment windows for CYP3A4, CYP2D6, P-gp or BCRP sensitive substrates, have been used.
- Receiving medication that is known to prolong the QT interval or may lead to torsade de pointes.
- Existing abnormal CTCAE ≥ grade 2 resulted from previous treatment.
- History of other malignancy.
- Uncontrolled pleural, ascites or pericardial effusion.
- Known and unstable central nervous system metastases.
- Inadequate bone marrow reserve or serious organ dysfunction.
- Severe, uncontrolled, or active cardiovascular disease.
- Severe or poorly controlled diabetes.
- Severe or poorly controlled hypertension.
- Clinically significant bleeding symptoms within 1 month before the first administration of HS-20105.
- Serious thrombosis events within 3 months before the first administration of HS-20105.
- Serious infection within 4 weeks before the first administration of HS-20105.
- Received continuous glucocorticoid treatment for more than 7 days within 28 days before the first administration of HS-20105.
- Active infectious disease.
- Hepatic encephalopathy, hepatorenal syndrome, or ≥ Child-Pugh B-grade cirrhosis.
- Serious or uncontrolled eye disease.
- Moderate to severe lung diseases that may interfere with the detection or management of drug-related pulmonary toxicity and seriously affect respiratory function.
- Severe neurological or mental disorders that can interfere with assessment.
- Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study.
- History of hypersensitivity to any active or inactive ingredient of HS-20105.
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT06144723
Start Date
March 1 2024
End Date
March 1 2027
Last Update
November 22 2023
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