Study of HS-20105 for Injection in Patients With Advanced Solid Tumors.

• Status: Not yet recruiting
• Trial end date: 2027-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hansoh BioMedical R&D Company

Criteria

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.