Advanced Solid Tumors
Conditions
Keywords
Advanced Solid Tumors, HS-20122
Brief summary
This is a first-in-human (FIH) Phase I, multi-center, open-label, study of HS-20122, in patients with advanced solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-20122 in advanced solid tumors.
Interventions
DRUGHS-20122
Intravenous (IV) administration of HS-20122 ; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Sponsors
Hansoh BioMedical R&D Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females, aged ≥ 18 years. * Subjects with histologically or cytologically confirmed locally advanced or metastatic Solid Tumors * Standard treatment is invalid, unavailable or intolerable. * At least 1 target lesion according to RECIST 1.1. * ECOG PS score: 0-1. * Estimated Life expectancy\> 12 weeks. * Men or women should be using adequate contraceptive measures throughout the study. * Women must have the evidence of non-childbearing potential. * Signed and dated Informed Consent Form.
Exclusion criteria
* Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity * History of other primary malignancies. * Inadequate bone marrow reserve or organ dysfunction. * Evidence of cardiovascular risk. * Subjects with severe or poorly controlled diabetes. * Subjects with severe or poorly controlled hypertension. * Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose. * Subjects with severe arteriovenous thrombotic events within 3 months. * Subjects with severe infection within 4 weeks prior to the first dose. * Subjects who have received steroid therapy for more than 30 days . * Presence of known active infectious diseases. * Presence of clinically significant gastrointestinal dysfunction. * Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ Child-Pugh Grade B. * Moderate to severe pulmonary diseases. * Prior history of significant neurological or mental disorders. * Women who are breastfeeding or pregnant or planned to be pregnant during the study period. * Hypersensitivity to any ingredient of HS-20122. * Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator * Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity * History of other primary malignancies. * Inadequate bone marrow reserve or organ dysfunction. * Evidence of cardiovascular risk. * Subjects with severe or poorly controlled diabetes. * Subjects with severe or poorly controlled hypertension. * Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose. * Subjects with severe arteriovenous thrombotic events within 3 months. * Subjects with severe infection within 4 weeks prior to the first dose. * Subjects who have received steroid therapy for more than 30 days . * Presence of known active infectious diseases. * Presence of clinically significant gastrointestinal dysfunction. * Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ Child-Pugh Grade B. * Moderate to severe pulmonary diseases. * Prior history of significant neurological or mental disorders. * Women who are breastfeeding or pregnant or planned to be pregnant during the study period. * Hypersensitivity to any ingredient of HS-20122. * Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator * Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The maximum tolerated dose (MTD) or the maximum applicable dose (MAD) | From time of first dose of HS-20122 to end of DLT period (approximately 21 days) | To determine the MTD or MAD for further evaluation of intravenous administration of HS-20122 in subjects with advanced solid tumors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dose-limiting toxicities (DLT) as defined in the protocol | From time of first dose of HS-20122 to end of DLT period (approximately 21 days) | Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol |
| Observed maximum drug concentration (Cmax) of HS-20122 (including antibody-drug conjugates, total antibody, and payload) | From the date of first dose until 30 days after the final dose | The Cmax is the maximum observed drug concentration of HS-20122 |
| Time to reach maximum observed drug concentration (Tmax) of HS-20122 (including antibody-drug conjugates, total antibody, and payload) | From the date of first dose until 30 days after the final dose. | The Tmax is defined as time to reach maximum observed drug concentration of HS-20122. |
| Incidence and severity of adverse events (AEs) | From time of Informed Consent to 28 days post last dose of HS-20122 | Assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram, and NCI CTCAE v5.0. |
| Area under the curve from time Zero to end of dosing interval (AUC0-∞) of HS-20122 (including antibody-drug conjugates, total antibody, and payload) | From the date of first dose to Cycle 4(each cycle is 28 days) pre-dose | The AUC0-∞ is defined as the area under the drug concentration-time curve from time 0 to infinity |
| Incidence of anti-HS-20122 antibody (ADA) | From the date of first dose until 30 days after the final dose. | ADA incidence was defined as the percentage of participants whose ADA status were identified as positive. |
| Objective response rate (ORR) | up to 24 months | ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigators based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 |
| Area under the curve from time Zero to end of dosing interval (AUC0-t) of HS-20122 (including antibody-drug conjugates, total antibody, and payload) | From the date of first dose to Cycle 4(each cycle is 28 days) pre-dose. | The AUC0-t is defined as the area under the drug concentration-time curve during a dose interval time period(t) |
Countries
China
Contacts
Primary ContactKetao Chen
Outcome results
None listed