OncoMatch/Clinical Trials/NCT06552598
The Safety, Tolerability, and Efficacy of KD01 in Gynecologic Malignancies
Is NCT06552598 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies KD01(the recombinant oncolytic adenovirus) for cervical cancer.
Treatment: KD01(the recombinant oncolytic adenovirus) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cervical Cancer
Endometrial Cancer
Disease stage
Required: Stage IA1, IA2 (FIGO 2018 (cervical), FIGO 2023 (endometrial))
Grade: Grade 1Grade 2 (FIGO)
Cervical: staged as IB1 (tumor size ≥ 1 cm), IB2, IB3 (tumor size ≤ 5 cm), or IIA1 (FIGO 2018 ). Endometrial: FIGO Grade 1-Grade 2, FIGO 2023 Stage IA1 and IA2
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy
have failed systemic therapy...that have progressed after adequate treatment and for which no effective therapy is available, or no standard therapy exists
Cannot have received: nitrosourea
Receipt of nitrosourea or mitomycin C within 6 weeks prior to the first dose
Cannot have received: mitomycin C
Receipt of nitrosourea or mitomycin C within 6 weeks prior to the first dose
Cannot have received: oral fluoropyrimidine
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)
Cannot have received: small-molecule targeted agent
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)
Cannot have received: traditional Chinese medicine with anti-tumor indications
Receipt of traditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first dose
Cannot have received: chemotherapy
Exception: excluding progestogen use in Phase II Cohort B
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
Cannot have received: radiotherapy
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
Cannot have received: biological therapy
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
Cannot have received: endocrine therapy
Exception: excluding progestogen use in Phase II Cohort B
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
Cannot have received: immunotherapy
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
Cannot have received: oncolytic virus
Prior treatment with oncolytic viruses or oncolytic bacteria
Cannot have received: oncolytic bacteria
Prior treatment with oncolytic viruses or oncolytic bacteria
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L; Platelet Count ≥ 75 × 10⁹/L; Hemoglobin ≥ 90 g/L (no blood transfusion or hematopoietic stimulant therapy within 14 days prior to screening)
Kidney function
Creatinine ≤ 1.5 × ULN; Creatinine Clearance (Ccr) > 50 mL/min if Cr > 1.5 × ULN
Liver function
Total Bilirubin (TBIL) ≤ 1.5 × ULN; ALT ≤ 3 × ULN (≤ 5 × ULN with liver metastases or primary liver cancer); AST ≤ 3 × ULN (≤ 5 × ULN with liver metastases or primary liver cancer)
Cardiac function
No major organ dysfunction, including cardiac; QTcF < 460 ms; NYHA < II; LVEF ≥ 50%
No major organ dysfunction, including but not limited to hematopoietic, cardiac, pulmonary, hepatic, and renal function. Hematological system: ANC ≥ 1.5 × 10⁹/L, Platelet Count ≥ 75 × 10⁹/L, Hemoglobin ≥ 90 g/L (no blood transfusion or hematopoietic stimulant therapy within 14 days prior to screening). Hepatic System: TBIL ≤ 1.5 × ULN; ALT ≤ 3 × ULN (≤ 5 × ULN with liver metastases or primary liver cancer); AST ≤ 3 × ULN (≤ 5 × ULN with liver metastases or primary liver cancer). Renal System: Creatinine ≤ 1.5 × ULN; Ccr > 50 mL/min if Cr > 1.5 × ULN. Cardiac: QTcF < 460 ms; NYHA < II; LVEF ≥ 50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify