Cervical CancerPhase 1NCT06552598
The Safety, Tolerability, and Efficacy of KD01 in Gynecologic Malignancies
A Phase 1 study testing KD01(the recombinant oncolytic adenovirus) in people with Cervical Cancer and Gynecologic Malignancies, run by Tongji Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Gynecologic Malignancies, Endometrial Cancer
- What is being tested?
- KD01(the recombinant oncolytic adenovirus)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 1.History of Severe Cardiovascular and Cerebrovascular Diseases, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities requiring clinical intervention (e.g., symptomatic ventricular arrhythmias, Grade II-III atrioventricular block);
- Corrected QT interval (QTcF) ≥ 460 ms on 12-lead electrocardiogram at rest;
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥ 3 cardiovascular events within 6 months prior to the first dose;
- New York Heart Association (NYHA) Functional Class ≥ II, left ventricular ejection fraction (LVEF) < 50%, or other structural heart diseases deemed high-risk by the investigator;
- Clinically uncontrolled hypertension.
Show all 21Show fewer
- 2.Phase II: Imaging evidence of significant retroperitoneal lymph node metastasis;Cohort A (Cervical Cancer Cohort): Imaging evidence of lower uterine segment or endometrial involvement; Cohort B (Endometrial Cancer Cohort): Imaging evidence of deep myometrial, cervical, or extrauterine tumor invasion.
- 3.Clinically significant serous effusion requiring intervention within 4 weeks prior to informed consent.
- 4.History of autoimmune disease, immune system dysfunction, or organ transplantation.
- 5.Active infection requiring systemic anti-infective therapy (routine prophylactic anti-infective therapy per clinical trial institution is excluded); or unexplained fever > 38.5°C during screening.
- 6.Positive results for human immunodeficiency virus antibody (HIV-Ab) or treponema pallidum antibody; active hepatitis B (hepatitis B surface antigen [HBsAg] positive with HBV-DNA > 500 IU/mL or above the lower limit of detection of the clinical trial institution, if the lower limit is higher than 500 IU/mL); active hepatitis C (patients with positive HCV antibody but undetectable HCV-RNA are eligible). Patients receiving prophylactic antiviral therapy (excluding interferon) are eligible.
- 7.Uncontrolled seizures, central nervous system disorders, or psychiatric conditions resulting in cognitive impairment.
- 8.Adverse reactions from prior anti-tumor therapy have not resolved to grade ≤ 1 (per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0), with the exception of toxicities judged by the investigator to pose no safety risks (e.g., alopecia).
- 9.Current requirement for antiviral therapy, or use of antiviral drugs within 2 weeks prior to the first dose of study drug.
- 10.Receipt of nitrosourea or mitomycin C within 6 weeks prior to the first dose;Receipt of oral fluoropyrimidines or small-molecule targeted agents within 2 weeks prior to the first dose or within 5 half-lives of the drug (whichever is longer);Receipt of traditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first dose;Receipt of other chemotherapy, radiotherapy, biological therapy, endocrine therapy (excluding progestogen use in Phase II Cohort B), immunotherapy, etc., within 4 weeks prior to the first dose.
- 11.Receipt of systemic glucocorticoids (prednisone > 10 mg/day or equivalent dose of similar drugs) or other immunosuppressive agents within 14 days prior to the first dose, excluding: Topical, ophthalmic, intra-articular, intranasal, or inhaled glucocorticoid therapy;Short-term glucocorticoid use for prophylactic purposes (e.g., prevention of contrast-induced allergy).
- 12.Prior treatment with oncolytic viruses or oncolytic bacteria.
- 13.Vaccination within 28 days prior to the first dose.
- 14.Pregnant or lactating women.
- 15.History of severe allergies or allergic diathesis.
- 16.Other conditions deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qinglei Gao, PhD, MD, +86-13871127473, qingleigao@hotmail.com
Qinglei Gao, PhD, MD
About this study
Official title: Phase I/II Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Local Administration of Recombinant Oncolytic Adenovirus Injection (KD01) in Patients With Gynecologic Malignancies
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.
- Being tested
- KD01(the recombinant oncolytic adenovirus)
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KD01(the recombinant oncolytic adenovirus)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| KD01 treatment | Experimental | Local administration of Recombinant Oncolytic Adenovirus Injection (KD01) in gynecologic malignancies. Receives: Drug: KD01(the recombinant oncolytic adenovirus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAEs and AEs in Phase I
Incidence of serious adverse events (SAEs), incidence and severity of adverse events (AEs).
Measured: 2 years
MTD and RD in Phase I
Determine the maximum tolerated dose (MTD) based on the incidence of dose-limiting toxicities (DLTs), and derive the recommended dose (RD) for monotherapy.
Measured: 2 years
ORR in Phase II Cohort A
Objective response rate (ORR) following neoadjuvant therapy (preoperative treatment).
Measured: 2 years
CR in Phase II Cohort B
Complete response (CR) rate at 6 months.
Measured: 6 months
Secondary outcomes (5)
Biodistribution in Phase I
The detected concentrations of KD01 in blood, urine, feces, saliva, and injection site tissues.
Measured: 2 years
RFS in Phase II
2-year recurrence-free survival (RFS) rate.
Measured: 2 years
pCR in Phase II Cohort A
Pathological complete response (pCR) rate following neoadjuvant therapy (preoperative treatment)
Measured: 2 years
Disease response rate in Phase II Cohort B
Disease response rate at 12 months.
Measured: 12 months
SAEs and AEs in Phase II
Incidence of serious adverse events (SAEs), incidence and severity of adverse events (AEs).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qinglei Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552598
- Sponsor's protocol ID
- 2024-TJ-KD01
- Status last verified
- Jan 2026
- First submitted
- 11 Aug 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Local Administration of Recombinant Oncolytic Adenovirus Injection (KD01) in Patients With Gynecologic Malignancies
- ClinicalTrials.gov ID
- NCT06552598
- Acronym / sponsor ID
- 2024-TJ-KD01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KD01 treatment | Experimental | Drug: KD01(the recombinant oncolytic adenovirus)Local administration of Recombinant Oncolytic Adenovirus Injection (KD01) in gynecologic malignancies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- 1.History of Severe Cardiovascular and Cerebrovascular Diseases, including but not limited to:
- 2.Phase II: Imaging evidence of significant retroperitoneal lymph node metastasis;Cohort A (Cervical Cancer Cohort): Imaging evidence of lower uterine segment or endometrial involvement; Cohort B (Endometrial Cancer Cohort): Imaging evidence of deep myometrial, cervical, or extrauterine tumor invasion.
- 3.Clinically significant serous effusion requiring intervention within 4 weeks prior to informed consent.
- 4.History of autoimmune disease, immune system dysfunction, or organ transplantation.
- 5.Active infection requiring systemic anti-infective therapy (routine prophylactic anti-infective therapy per clinical trial institution is excluded); or unexplained fever > 38.5°C during screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | KD01 treatment |
Primary outcome
SAEs and AEs in Phase I
Time frame: 2 years
Incidence of serious adverse events (SAEs), incidence and severity of adverse events (AEs).
MTD and RD in Phase I
Time frame: 2 years
Determine the maximum tolerated dose (MTD) based on the incidence of dose-limiting toxicities (DLTs), and derive the recommended dose (RD) for monotherapy.
ORR in Phase II Cohort A
Time frame: 2 years
Objective response rate (ORR) following neoadjuvant therapy (preoperative treatment).
CR in Phase II Cohort B
Time frame: 6 months
Complete response (CR) rate at 6 months.
5 secondary outcomes
Biodistribution in Phase I
Time frame: 2 years
RFS in Phase II
Time frame: 2 years
pCR in Phase II Cohort A
Time frame: 2 years
Disease response rate in Phase II Cohort B
Time frame: 12 months
SAEs and AEs in Phase II
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KD01(the recombinant oncolytic adenovirus) in people with Cervical Cancer and Gynecologic Malignancies, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qinglei Gao, PhD (15391566981, qingleigao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAEs and AEs in Phase I (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.