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A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for ESCC

NCT07385001 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-02-03

No results posted yet for this study

Summary

A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined with Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for Resectable, Locally Advanced Esophageal Squamous Cell Carcinoma

Conditions

Interventions

DRUG

AK112

Cohort 1- AK112 10 mg/kg, every 3 weeks (Q3W), administered intravenously on day 1. Treatment will begin with the first patient. If the first patient does not experience any treatment-related safety issues, at least 24 hours will pass before the next 2 or 3 patients are treated.The dosing regimen and interval will remain unchanged for all patients

DRUG

AK112

Cohort 2- AK112 dose of 20 mg/kg, every 3 weeks (Q3W), administered intravenously on day 1. Treatment will begin with the first patient. If the first patient does not experience any treatment-related safety issues, at least 24 hours will pass before the next 2 or 3 patients are treated.The dosing regimen and interval will remain unchanged for all patients

DRUG

AK112 + Neoadjuvant chemotherapy

Neoadjuvant chemotherapy: Albumin-paclitaxel 130 mg/m², intravenous infusion on days 1 and 8, every 3 weeks (Q3W), total of 3 cycles Carboplatin with an area under the curve (AUC) of 5 mg/ml/min, intravenous infusion on day 1, every 3 weeks (Q3W), total of 3 cycles AK112: Based on the data collected during the dose-escalation phase 1b

Sponsors & Collaborators

  • Tang-Du Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-28
Primary Completion
2027-01-28
Completion
2028-01-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07385001 on ClinicalTrials.gov