The purpose of this study is to evaluate the efficacy and safety of KC1036 in combination with PD-1 antibody and platinum-based chemotherapy as a first-line treatment for patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).
This multicenter Phase II study evaluates KC1036 in combination with PD-1 antibody and platinum-based chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma. The trial comprises a Phase IIa dose-escalation and expansion phase to assess the safety of KC1036 at 20, 30, or 40 mg QD, followed by a Phase IIb randomized evaluation of 2-3 cohorts (up to 50 subjects per arm) to identify the recommended Phase III dose. Subjects receive daily oral KC1036 plus toripalimab, paclitaxel, and cisplatin every 3 weeks until confirmed disease progression assessed by the RECIST V1.1 standard, death, intolerable toxicity, initiation of a new anti-tumor therapy, other reasons leading to treatment discontinuation as specified by protocol.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Dosage: 20 mg, 30 mg, or 40 mg; Route: Oral; Frequency: Once daily (QD) under fasting conditions (at least 2 hours before and 1 hour after dosing), 21 days as a cycle.
Dosage: 240 mg; Route: Intravenous (IV) infusion; Frequency: Every 3 weeks (Q3W) on Day 1 of each 21-day cycle, for up to 2 years.
Dosage: 175 mg/m2; Route: IV infusion; Frequency: Day 1 of each 21-day cycle, for a maximum of 6 cycles.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGObjective Response Rate (ORR)
ORR is defined as the proportions of patients with a complete response (CR) or partial response (PR) according to RECIST 1.1.
Time frame: Baseline to study completion (approximately 24 months)
Progression-free survival (PFS)
PFS is defined as the time from the first study drug administration to the date of the first documented progressive disease (PD) according to RECIST 1.1 or death.
Time frame: Baseline to study completion (approximately 24 months)
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a best overall complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.
Time frame: Baseline to study completion (approximately 24 months)
Duration of Response (DOR)
DOR is defined as the time from first documented objective response (complete response (CR)or partial response (PR)) to the date of first documented disease progression (PD) or death.
Time frame: Baseline to study completion (approximately 24 months).
TTR
TTR is defined as the time from the start of the first study drug administration to the date of the first documented response of complete response (CR) or partial response (PR) according to RECIST 1.1.
Time frame: Baseline to study completion (approximately 24 months)
Adverse events (AEs)
Assessed by treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the treatment assessed by NCI CTCAE 5.0.
Time frame: Baseline to 30 days after the last dose of study treatment
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Dosage: 60-75 mg/m2; Route: IV infusion; Frequency: Day 1 of each 21-day cycle, for a maximum of 6 cycles.
Dosage: Selected doses from Phase IIa (20 mg, 30 mg, or 40 mg); Route: Oral; Frequency: Once daily (QD) under fasting conditions, 21 days as a cycle.