A Phase Ia/Ib Safety and Tolerability Evaluation of Low-dose Radiation in Combination with CS1001 in relapsed SCLC patients
This is a dose-escalation study of Low-dose Radiation in combination with CS1001 in relapsed SCLC patients. Patients are assigned to 3 treatment groups received from 3 Gy to 15Gy, to determine the safety, tolerability and the maximal tolerant dose. Biomarkers and immunological markers are collected and analyzed as well.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
low-dose radiation+CS1001 1200mg Q3W. In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. Dose A: 3Gy/1f; Dose B: 9Gy/3f; Dose C: 15Gy/5f; In the dose expansion part, more SCLC patients will be assigned.
West China Hospital, Sichuan University
Chengdu, Sichuan, China
To determine the recommended radiation dose and preliminarily evaluate the anti-tumor efficacy of CS1001 in combination with low-dose radiotherapy in subjects with limited or extensive stage SCLC who failed the firstline treatment
Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Incidence of Adverse Events (AE) and Dose-Limiting Toxicity (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) V4.03
Time frame: From first dose to 30 days after last dose of CS1001, up to 2 years.
Cmax: Peak concentration, the maximum drug concentration measured during one dosing cycle
Time frame: From first dose to 30 days after last dose of CS1001, up to 2 years.
The number and percentage of subjects with detectable Anti-drug Antibody (ADA)
Time frame: From first dose to 30 days after last dose of CS1001, up to 2 years.
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