Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic and the Therapeutic Potential of HS-20105 for Injection in Patients With Advanced Solid Tumors.

HS-20105-101

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 pharmacokinetics (PK), safety and preliminary anti-tumor activity of HS-20105 in patients with advanced solid tumors.

2024-03-01

2026-03-01

2027-03-01

Not yet recruiting

Early phase I

402

Inclusion Criteria: * 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 Criteria: * Has received or is currently undergoing the following treatment: 1. Previously or current treatment with drugs targeting Trop-2 or other ADC drugs conjugated with HS-9265; 2. Received traditional Chinese medicine therapy with anti-tumor indications within 2 weeks prior to the first administration of HS-20105; 3. 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; 4. Received macromolecular anti-tumor drugs or experimental drug therapy within 4 weeks before the first administration of HS-20105; 5. 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; 6. Received major surgery within 4 weeks before the first administration of HS-20105. 7. 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. 8. 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 402, 'type': 'ESTIMATED'}}

2023-11-22