The Safety, Tolerability, and Efficacy of KD01 in Cervical Malignancies

PHASE1RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

April 1, 2028

Study Completion Date

April 1, 2028

Conditions
Cervical Cancer
Interventions
DRUG

KD01(the recombinant oncolytic adenovirus)

"Phase Ia PART 1 (Dose Escalation Phase with Monotherapy): Subjects in each dose group will continue to undergo a 21-day assessment for Dose-Limiting Toxicity (DLT) after completing the first cycle of treatment (D1-5), totaling 26 days starting from D1.~Phase Ib PART 2 (Dose Expansion Phase with Monotherapy): Subjects will receive intratumoral injections, starting on D1. Further treatment will continue based on the patient's willingness, with a maximum of 5 administrations. The final administration will be followed by surgery 7-14 days later, until the patient is discharged."

Trial Locations (1)

430030

RECRUITING

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan

All Listed Sponsors
lead

Tongji Hospital

OTHER