This is an open-label, dose-escalation and cohort expansion study to evaluate the safety and preliminary efficacy of YSCH-01 in subjects with pulmonary metastasis of advanced solid tumors and advanced non-small cell lung cancer by nebulized inhalation administration. This study is consisting of two phases: the dose escalation phase and the cohort expansion phase.
In dose escalation phase, subjects with pulmonary metastasis of advanced solid tumors and advanced non-small cell lung cancer will be enrolled to receive YSCH-01 treatment by inhalation via nebulization. The "3+3" design will be adopted to explore the MTD and determine RP2D. Two dose groups will be established as follows: Dose group 1: 2E+11 VP; Dose group 2: 4E+11 VP. All the subjects received a single dose of YSCH-01 treatment, followed by a 21-day DLT observation period. If no DLT occurred, the YSCH-01 will administered once a week thereafter until the investigator deemed that the subjects no longer benefited significantly, experienced intolerable toxicity, withdrew their informed consent, had disease progression, died, were lost to follow-up, or the investigator deemed that terminating the treatment was in the best interest of the subjects (whichever occurred first). In cohort expansion phase, subjects will receive the optimal dose and administration schedule determined during the dose escalation phase. The cohort expansion phase further evaluated the safety and preliminary efficacy of YSCH-01 and planned to include 3 cohorts, with 10-30 subjects in each cohort.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
YSCH-01, 2.0×10¹¹ VP, inhalation via nebulizer; the second administration is to be given 21 days after the first administration, and then once weekly thereafter.
YSCH-01, 4.0×10¹¹ VP, inhalation via nebulizer; the second administration is to be given 21 days after the first administration, and then once weekly thereafter.
No.17 Panjiayuan Nanli, Chaoyang District, Beijing
Beijing, China
RECRUITINGIncidence and characteristics of AE/SAE
Type, frequency, severity, and relationship to study treatment of AEs and SAEs assessed per NCI-CTCAE v5.0
Time frame: From the date of first dose up to 28 days after the date of last dose
Incidence of Dose Limiting Toxicities (DLT)
The proportion of subjects who experienced the defined DLT as per the protocol during the DLT observation period after receiving YSCH-01 treatment
Time frame: Within 21 days following the date of the first administration of YSCH-01
Determine the maximum tolerated dose (if applicable)
Maximum tolerated dose is defined as the highest dose level with a DLT incidence rate ≤ 1/6 per standard "3+3" dose escalation rules.
Time frame: Within 21 days following the date of the first administration of YSCH-01
Objective Response Rate (ORR)
The proportion of subjects who achieved confirmed CR or PR during the period from the first dose up to 12 months following the last dose of study treatment, and who did not initiate any new anticancer therapy within 12 months after the last dose of study treatment. Tumor assessments will be performed every 6 weeks after the first dose during treatment. For subjects who discontinue study treatment without disease progression, tumor assessments will be conducted every 12 weeks thereafter until disease progression, initiation of new anticancer therapy, withdrawal of informed consent, death, or 12 months following the last dose of study treatment, whichever occurs first.
Time frame: The maximum estimated time for each subject to undergo tumor assessment is 30 months.
Disease Control Rate (DCR)
The proportion of patients whose tumor assessment reached SD, PR or CR during the research process among the total number of enrolled patients; The patients whose tumor assessment reached SD, PR or CR include the following types: 1. Subjects who were evaluated as SD, PR or CR during the study treatment; 2. Subjects who were not PD and were excluded from the study, and after exclusion, did not receive other anti-tumor drug treatment, and whose tumors were evaluated as SD, PR or CR. (For subjects excluded due to non-PD, a tumor assessment will be conducted every 12 weeks until disease progression, initiation of new anti-cancer treatment, withdrawal of informed consent, death, or 12 months after the last study treatment administration, whichever occurs earlier.
Time frame: The maximum estimated time for each subject to undergo tumor assessment is 30 months.
progression free survival (PFS)
The period from the first dose to the date of the first occurrence of disease progression or death due to any cause
Time frame: The maximum estimated time for each subject to undergo tumor assessment is 30 months.
overall survival (OS)
The period from the time of the first dose to the date of death due to any cause by the subject
Time frame: The maximum estimated time for each subject to undergo tumor assessment is 30 months.
LI NING Vice President of Cancer Hospital, Chinese Academy of Medical, Doctorate
CONTACT
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