[Translation] A multicenter, open-label phase I/II clinical study evaluating the safety, tolerability, immunogenicity, and preliminary efficacy of KDTV001 injection in the treatment of high-grade squamous intraepithelial lesions (HSIL) of the cervix.
主要目的:
I期剂量递增阶段:
评价KDTV001注射液治疗子宫颈高级别鳞状上皮内病变(HSIL)的安全性、耐受性和免疫原性;确定评价KDTV001注射液在子宫颈高级别鳞状上皮内病变(HSIL)试验参与者中的最佳生物剂量(optimal biological dose,OBD)或最大耐受剂量(Maximal tolerance dose, MTD)。
Ⅱ期剂量扩展阶段:评估KDTV001注射液在子宫颈HSIL的初步有效性。
次要目的:
I期剂量递增阶段:评估KDTV001注射液治疗子宫颈HSIL的初步有效性;
Ⅱ期剂量扩展阶段:评价KDTV001注射液的免疫原性;评价KDTV001注射液治疗子宫颈HSIL的安全性、耐受性。
探索性目的:
KDTV001治疗宫颈HSIL的伴随生物标记物。
[Translation] Primary Objectives:
Phase I Dose Escalation Phase: To evaluate the safety, tolerability, and immunogenicity of KDTV001 injection in the treatment of high-grade squamous intraepithelial lesions (HSIL) of the cervix; to determine the optimal biological dose (OBD) or maximum tolerated dose (MTD) of KDTV001 injection in participants of HSIL trials.
Phase II Dose Expansion Phase: To assess the preliminary efficacy of KDTV001 injection in cervical HSIL.
Secondary Objectives:
Phase I Dose Escalation Phase: To assess the preliminary efficacy of KDTV001 injection in the treatment of cervical HSIL;
Phase II Dose Expansion Phase: To evaluate the immunogenicity of KDTV001 injection; to evaluate the safety and tolerability of KDTV001 injection in the treatment of cervical HSIL.
Exploratory Objectives: To identify accompanying biomarkers for KDTV001 treatment of cervical HSIL.