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 age is 18~75 years old (including the critical value), regardless of gender.
Phase II cohort 1, cohort 2: locally advanced squamous cell carcinoma of the head and neck which only occurred in the oral cavity, oropharynx, hypopharynx and larynx after histological diagnosis or had no indication of radical local treatment; In the past, I only received ≤2 line therapy for recurrent and metastatic head and neck squamous cell carcinoma.
Phase II cohort 3, cohort 4, cohort 5: Histologically confirmed nasopharyngeal carcinoma, stage IVb or recurrent nasopharyngeal carcinoma that is not suitable for local treatment according to the TNM of AJCC nasopharyngeal carcinoma in the 8th edition of 2017; In the past, they only received ≤2 line therapy for recurrent and metastatic nasopharyngeal carcinoma.
According to the researcher's judgment, the chemotherapy in this experiment is applicable.
Received other unlisted clinical research drugs or treatments within 4 weeks before using the research drugs.
The adverse reactions of previous anti-tumor treatments have not recovered to NCI CTCAE 5.0 grade evaluation ≤1 grade or the relevant provisions of the selection criteria (except for the toxicity that the researchers judged to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.).
It is known that it has hypersensitivity to any antibody drugs (NCI CTCAE 5.0 rating is ≥3), or it has hypersensitivity to research drugs, active ingredients or inactive excipients of chemotherapy schemes.
Have received major surgery (excluding puncture biopsy), major trauma or need to undergo elective surgery during the trial within 4 weeks before the first use of the study drug.
Single group
IAE0972+ Methotrexate
Biological/VaccineIAE0972: 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+Docetaxel
Biological/VaccineIAE0972: 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+Gemcitabine
Biological/VaccineIAE0972: 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+Taxanes
Biological/VaccineIAE0972: 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+Capecitabine
Biological/VaccineIAE0972: 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.
Overall survival (OS)
OS is defined as the time from the date of first dosing to death from any cause
Objective response rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1
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)
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