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

NCT06552598 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2026-01-15

No results posted yet for this study

Summary

Recombinant oncolytic adenovirus injection (KD01)is an oncolytic vius product. Its main component is a conditionally replicativerecombinant human type 5 adenovirus, where part of the E3 region has been replaced with the gene encoding the tBid apoptoticprotein.AK104 is a humanized bispecific antibody co-targeting PD-1 (Programmed Cell Death Protein 1) and CTLA-4 (Cytotoxic T-Lymphocyte-Associated Antigen 4)-two key immune checkpoint receptors. It is designed as a novel tetrameric construct that preferentially binds to tumor-infiltrating lymphocytes (TILs) co-expressing PD-1 and CTLA-4 in the tumor microenvironment (withhigher avidity than in peripheral tissues).This study aims to investigate the therapeutic efficacy and safety of recombinant oncolytic adenovirus (KD01) in patients with gynecologic malignancies. Meanwhile, it will explore the impact of KD01 on the immune function of cervical cancer patients as well as its tumor cell-killing mechanism. This research is expected to provide novel strategies and approaches for the treatment of gynecologic malignancies, and contribute to improving the rehabilitation and quality of life of patients.

The study is divided into Phase I and Phase II. Phase II consists of Cohort A (cervical cancer cohort) and Cohort B (endometrial cancer cohort).Phase I will include patients with gynecologic malignancies who have failed systemic therapy.Phase II will include reproductive-aged women with a strong desire to preserve fertility.Phase II Cohort A will include patients with cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma, staged as IB1 (tumor size ≥1 cm), IB2, IB3 (tumor size ≤5 cm) and IIA1 (based on FIGO 2018 staging system); baseline MRI examination confirms that the lesion does not involve the lower uterine segment; for patients in Stage II , the length of vaginal involvement is \< 2 cm.Phase II Cohort B will include patients with endometrial atypical hyperplasia or endometrial adenocarcinoma (FIGO Grade 1-Grade 2, FIGO 2023 Stage IA1 and IA2), with mismatch repair deficiency (MMRd) or no response to progestogen therapy; baseline MRI examination combined with chest CT or PET/CT confirms that the lesion is limited to the endometrial layer or superficial myometrium, without obvious involvement of the deep myometrium, cervix or extrauterine sites.

Conditions

Interventions

DRUG

KD01(the recombinant oncolytic adenovirus)

Drug: Phase I: KD01(1×10¹¹ VP, 1×10¹¹ VP, and 6×10¹¹ VP) Phase II Cohort A: KD01(3×10¹¹ VP)+AK104(6 mg/kg)+thymalfasin + rhGM-CSF Phase II Cohort B: KD01(1×10¹¹ VP) + LNG-IUS Administration： Phase I: KD01 will be administered of Cycle 1 (Days 1-5). And subsequent cycles will be repeated every 26 + 7 days thereafter. Phase II Cohort A: KD01 will be administered daily on Days 1-5).AK104will be administered on Day 14.KD01 will be resumed daily for up to 5 doses.A second dose of AK104 will be administered on Day 28.Concurrent administration of thymalfasin and rhGM-CSF.Efficacy assessment will be performed on Day 42 . The first elective surgery will be scheduled after evaluation by the investigator. Phase II Cohort B: Hysteroscopy will be performed on Day 1; subsequently, KD01 will be administered, and a LNG-IUS will be placed. Thereafter, hysteroscopic diagnostic curettage/biopsy will be carried out every 3 months, accompanied by administration of KD01 and placement of LNG-IUS.

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2028-04-01
Completion
2028-04-01

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 NCT06552598 on ClinicalTrials.gov