Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Conditions
Keywords
Small Cell Lung Cancer, HS-20093, B7H3, Antibody-Drug Conjugates, ZG006, DLL3, PD-L1 inhibitor
Brief summary
This is a multicenter, open-label Phase I study evaluating the safety, tolerability, pharmacokinetic, and efficacy of Intravenous HS-20093 in combination with ZG006 with or without adebrelimab in patients with extensive-stage small cell lung cancer.
Detailed description
This is a multicenter, open-label Phase I study evaluating the safety, tolerability, pharmacokinetic, and efficacy of Intravenous HS-20093 in combination with ZG006 with or without adebrelimab in patients with extensive-stage small cell lung cancer. The study involves two cohorts, Cohort 1: HS-20093 in combination with ZG006; Cohort 2: HS-20093 in combination with ZG006 and adebrelimab. Each cohort contains two dosing regimens: every two weeks (Q2W) and every three weeks (Q3W). Two phases are included in each cohort: dose exploration phase and dose expansion phase.
Interventions
The patient will be treated with HS-20093.
DRUGZG006
The patient will be treated with ZG006.
The patient will be treated with adebrelimab.
Sponsors
Hansoh BioMedical R&D Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent. 2. Men or women aged more than or equal to (≥) 18 years. 3. At least one extra-cranial measurable lesion according to RECIST 1.1. 4. Histologically or cytologically diagnosed as ES-SCLC. 5. Adequate organ function. 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1. 7. Life expectancy \>= 12 weeks. 8. Men or women should be using adequate contraceptive measures throughout the study. 9. Female participants with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.
Exclusion criteria
1. Uncontrolled pleural effusion or peritoneal effusion. 2. Adverse reactions caused by previous treatments. 3. History of other primary solid tumors. 4. Severe, uncontrolled or active cardiovascular or cerebrovascular diseases. 5. Severe or uncontrolled diabetes or hypertension. 6. Clinically significant hemorrhage symptoms or significant hemorrhagic tendency. 7. History of severe arterial-venous thrombosis within 3 months prior to the first administration. 8. History of severe infection within 4 weeks prior to the first administration. 9. Active autoimmune diseases or active infectious diseases. 10. History of severe neurological or mental disorders. 11. Hepatic encephalopathy, hepatorenal syndrome, or ≥ Child-Pugh class B cirrhosis. 12. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period. 13. Any condition that probably endangers the safety of the participants or interferes with the study assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The maximum tolerated dose (MTD) or maximum applicable dose (MAD) for combination treatments | Up to day 21 or 28 from the first dose | To determine the MTD or MAD for further evaluation of HS-20093 with other anti-cancer agents in subjects with Extensive Stage Small Cell Lung Cancer |
| The incidence rate of dose-limiting toxicities (DLT) events in combination treatments | Up to day 21 or 28 from the first dose | To determine the incidence rate of DLT events for further evaluation of HS-20093 with other anti-cancer agents in subjects with Extensive Stage Small Cell Lung Cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) determined by investigators | up to approximately 24 months | ORR is defined as the percentage of patients with a CR or PR that is confirmed at a subsequent scan at least 4 weeks later, as assessed according to RECIST version 1.1 |
| Disease control rate (DCR) determined by investigators | up to approximately 24 months | Disease control is defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 5 weeks). |
| Duration of response (DoR) determined by investigators | up to approximately 24 months | The duration of remission (DoR) is defined as the time period between the date of the first occurrence of remission and the date of the first disease progression or any cause of death. |
| Progression-free survival (PFS) determined by investigators according to RECIST 1.1 | up to approximately 24 months | PFS is defined as the time from first dose until PD or death from any cause (whichever occurred first). |
| Overall survival (OS) | Up to approximately 24 months. | OS is defined as time from first study treatment to death due to any cause. |
Outcome results
None listed