Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

September 27, 2024

Primary Completion Date

July 30, 2026

Study Completion Date

July 30, 2026

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

HER3 Monoclonal antibodies-Dose A

Dose A, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).

DRUG

HER3 Monoclonal antibodies-Dose B

Dose B, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).

DRUG

HER3 Monoclonal antibodies-Dose C

Dose C, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).

OTHER

HER3 Monoclonal antibodies-Dose D

The optimal recommended dosage (RP2D) of SIBP-03intravenous, infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).

OTHER

Placebo

SIBP-03 solvent without HER3 antibody, intravenous infusion (IV), once every one weeks, 21 days as a cycle.

COMBINATION_PRODUCT

Cetuximab injection

Medications used for combination therapy, intravenous infusion (IV). Administer once a week.

Trial Locations (1)

Unknown

RECRUITING

Shanghai East Hospital, Shanghai

All Listed Sponsors
lead

Shanghai Institute Of Biological Products

INDUSTRY