Phase II: To evaluate the safety and tolerability of IAE0972 combined with chemotherapy selected by doctors for R/M HNSCC/NPC after failure or progress of ≤2-line system therapy, and to determine the MTD of combined therapy. Phase III: According to the RECIST 1.1, the effectiveness of IAE0972 combined with chemotherapy regimen chosen by doctors compared with placebo plus chemotherapy regimen chosen by doctors was evaluated through OS in patients with R/M NPC who failed or progressed after treatment with ≤2-line system.
The Phase II is the dose escalation study of IAE0972 combined with the chemotherapy chosen by doctors, aiming at evaluating the safety, tolerance and preliminary effectiveness for patients with R/M HNSCC/NPC;Phase III aims to evaluate the effectiveness and safety of IAE0972+ doctors' chemotherapy compared with doctors' chemotherapy in patients with R/M NPC who have failed or progressed after treatment with ≤2-line system through OS.In the study, the adverse events and reactions were evaluated by clinical observation, vital signs monitoring and laboratory examination, and related samples such as PK and ADA were collected. Taking RECIST 1.1 as the tumor evaluation standard, after the first infusion of the study drug, every two cycles (±7 days, before the next cycle of administration, and the day of administration in this cycle is defined as D1 of the current cycle), the subjects were evaluated for tumor until the disease progressed, new anti-tumor treatment was started, the researchers judged that it was not suitable to continue to participate (such as intolerable adverse reactions), lost the visit, and voluntarily withdrew.When the subject withdraws from or terminates the treatment (+7 days), the subject should be visited before starting the new anti-tumor treatment (except death and lost visit), and relevant laboratory tests and ADA sample collection should be carried out; After that, their OS was followed up by telephone every 12 weeks (±7 days) until they were lost or died.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
IAE0972: every 21 days is defined as a treatment cycle, and IAE0972 is infused intravenously on the 1d, 8d and 15d of each cycle. The first infusion time is about 120 min (which can be adjusted according to the actual situation); If the subjects are well tolerated when they receive the study drug for the first time (according to CTCAE 5.0, the infusion-related reaction is ≤ grade 1), the follow-up infusion time can be 60\~90 min (which can be adjusted according to the actual situation).Methotrexate is used according to the instructions.
IAE0972: every 21 days is defined as a treatment cycle, and IAE0972 is infused intravenously on the 1d, 8d and 15d of each cycle. The first infusion time is about 120 min (which can be adjusted according to the actual situation); If the subjects are well tolerated when they receive the study drug for the first time (according to CTCAE 5.0, the infusion-related reaction is ≤ grade 1), the follow-up infusion time can be 60\~90 min (which can be adjusted according to the actual situation).Docetaxel is used according to the instructions.
IAE0972: every 21 days is defined as a treatment cycle, and IAE0972 is infused intravenously on the 1d, 8d and 15d of each cycle. The first infusion time is about 120 min (which can be adjusted according to the actual situation); If the subjects are well tolerated when they receive the study drug for the first time (according to CTCAE 5.0, the infusion-related reaction is ≤ grade 1), the follow-up infusion time can be 60\~90 min (which can be adjusted according to the actual situation).Gemcitabine is used according to the instructions.
IAE0972: every 21 days is defined as a treatment cycle, and IAE0972 is infused intravenously on the 1d, 8d and 15d of each cycle. The first infusion time is about 120 min (which can be adjusted according to the actual situation); If the subjects are well tolerated when they receive the study drug for the first time (according to CTCAE 5.0, the infusion-related reaction is ≤ grade 1), the follow-up infusion time can be 60\~90 min (which can be adjusted according to the actual situation).Taxanes is used according to the instructions.
IAE0972: every 21 days is defined as a treatment cycle, and IAE0972 is infused intravenously on the 1d, 8d and 15d of each cycle. The first infusion time is about 120 min (which can be adjusted according to the actual situation); If the subjects are well tolerated when they receive the study drug for the first time (according to CTCAE 5.0, the infusion-related reaction is ≤ grade 1), the follow-up infusion time can be 60\~90 min (which can be adjusted according to the actual situation).Capecitabine is used according to the instructions.
Number of participants with treatment-related adverse events assessed by CTCAE v5.0.
AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.
Time frame: up to 2 years
Overall survival (OS)
OS is defined as the time from the date of first dosing to death from any cause
Time frame: up to 2 years
Objective response rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1
Time frame: up to 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1
Time frame: up to 2 years
Progression-free survival (PFS)
PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1 criteria) or death from any cause (whichever occurs first)
Time frame: up to 2 years
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