A Clinical Trial to Evaluate Effect of IAE0972 Combined with Chemotherapy for R/M HNSCC or NPC(Note: It is Currently Phase II.).

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

January 1, 2028

Study Completion Date

January 1, 2028

Conditions
NPCHNSCCRecurrenceMetastasis
Interventions
BIOLOGICAL

IAE0972+ Methotrexate

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.

BIOLOGICAL

IAE0972+Docetaxel

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.

BIOLOGICAL

IAE0972+Gemcitabine

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.

BIOLOGICAL

IAE0972+Taxanes

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.

BIOLOGICAL

IAE0972+Capecitabine

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.

All Listed Sponsors
lead

SUNHO(China)BioPharmaceutical CO., Ltd.

INDUSTRY

NCT06719479 - A Clinical Trial to Evaluate Effect of IAE0972 Combined with Chemotherapy for R/M HNSCC or NPC(Note: It is Currently Phase II.). | Biotech Hunter | Biotech Hunter