Actively Recruiting
The Safety, Tolerability, and Efficacy of KD01 in Gynecologic Malignancies
Led by Tongji Hospital · Updated on 2026-01-15
97
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Safety, Tolerability, and Efficacy of KD01 in Gynecologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Phase I: Patients with gynecologic malignancies who have failed systemic therapy, with histologically or cytologically confirmed disease.
- Age 18 to 75 years old (inclusive).
- Phase II: Reproductive-aged women (recommended age 240 years or younger) with strong desire to preserve fertility.
- Cohort A: Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma, staged IB1 (tumor 251 cm), IB2, IB3 (tumor 245 cm), or IIA1; baseline MRI shows no involvement of lower uterine segment; vaginal involvement less than 2 cm for Stage II.
- Cohort B: Histologically confirmed endometrial atypical hyperplasia or adenocarcinoma (FIGO Grade 1-2, Stage IA1 and IA2), with mismatch repair deficiency or no response to progestogen therapy; imaging confirms lesions limited to endometrial layer or superficial myometrium without deep myometrium, cervix, or extrauterine involvement.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Expected survival of at least 3 months.
- No major organ dysfunction including hematopoietic, cardiac, pulmonary, hepatic, and renal functions.
- Hematological requirements: Absolute Neutrophil Count 21.5 �d7 10/L; Platelet Count 275 �d7 10/L; Hemoglobin 290 g/L.
- Hepatic function: Total Bilirubin 21.5 times upper limit of normal; ALT and AST 2 to 3 times upper limit of normal (up to 5 times for liver metastases or primary liver cancer).
- Renal function: Creatinine 21.5 times upper limit of normal; Creatinine Clearance (if applicable) above 50 mL/min.
- Coagulation: Activated Partial Thromboplastin Time and INR less than or equal to 1.5 times upper limit of normal.
- Premenopausal women must have a negative pregnancy test at screening.
- Agreement to use reliable contraception from screening until 3 months after last dose.
- Signed informed consent with full understanding of the trial.
You will not qualify if you...
- History of severe cardiovascular or cerebrovascular diseases including serious arrhythmias, corrected QT interval 2460 ms, recent acute coronary syndrome, heart failure, stroke, or other severe cardiovascular events within 6 months.
- New York Heart Association Functional Class 2 or left ventricular ejection fraction less than 50%, or other high-risk structural heart diseases.
- Clinically uncontrolled hypertension.
- Phase II: Imaging showing significant retroperitoneal lymph node metastasis; lower uterine segment or endometrial involvement in Cohort A; deep myometrial, cervical, or extrauterine tumor invasion in Cohort B.
- Clinically significant serous effusion requiring intervention within 4 weeks prior to consent.
- History of autoimmune disease, immune dysfunction, or organ transplant.
- Active infection needing systemic treatment or unexplained fever over 38.5°C during screening.
- Positive HIV antibody or treponema pallidum antibody tests; active hepatitis B or C infection (with some exceptions).
- Uncontrolled seizures, central nervous system or psychiatric disorders causing cognitive impairment.
- Unresolved adverse reactions from prior anti-tumor therapy above grade 1 except for non-safety risks.
- Need for antiviral therapy or antiviral use within 2 weeks before study drug.
- Recent chemotherapy, radiotherapy, biological therapy, endocrine therapy (except progestogen in Phase II Cohort B), or immunotherapy within specified intervals before first dose.
- Use of systemic glucocorticoids or immunosuppressants within 14 days before first dose, with some exceptions.
- Prior treatment with oncolytic viruses or bacteria.
- Vaccination within 28 days prior to first dose.
- Pregnant or lactating women.
- History of severe allergies or allergic conditions.
- Other conditions deemed unsuitable by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
Q
Qinglei Gao, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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