OncoMatch/Clinical Trials/NCT06552598
The Safety, Tolerability, and Efficacy of KD01 in Gynecologic Malignancies
Is NCT06552598 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Cervical Cancer
Endometrial Cancer
Biomarker criteria
Required: MLH1 loss
Required: MSH2 loss
Required: MSH6 loss
Required: PMS2 loss
Disease stage
Required: Stage IA1, IA2 (FIGO)
Grade: Grade 1, Grade 2 (FIGO)
Cohort A: staged as IB1 (tumor size ≥ 1 cm), IB2, IB3 (tumor size ≤ 5 cm), or IIA1 (FIGO 2018 ). Cohort B: FIGO Grade 1-Grade 2, FIGO 2023 Stage IA1 and IA2
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: oncolytic viruses
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; PLT ≥ 75 × 10⁹/L; Hb ≥ 90 g/L
Kidney function
Cr ≤ 1.5 × ULN; Ccr > 50 mL/min (if Cr > 1.5 × ULN)
Liver function
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; LVEF ≥ 50%; NYHA < II
No major organ dysfunction, including but not limited to hematopoietic, cardiac, pulmonary, hepatic, and renal function. Hematological: ANC ≥ 1.5 × 10⁹/L, PLT ≥ 75 × 10⁹/L, Hb ≥ 90 g/L. Hepatic: TBIL ≤ 1.5 × ULN, ALT ≤ 3 × ULN (≤ 5 × ULN with liver mets or primary liver cancer), AST ≤ 3 × ULN (≤ 5 × ULN with liver mets or primary liver cancer). Renal: Cr ≤ 1.5 × ULN; Ccr > 50 mL/min (if Cr > 1.5 × ULN). Cardiac: QTcF < 460 ms; LVEF ≥ 50%; NYHA < II.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06552598 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior oncolytic viruses, oncolytic bacteria disqualifies patients from enrollment.
Does this trial require MLH1?
Yes, MLH1 loss is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 loss is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 loss is a required biomarker for enrollment.
What disease stage is eligible?
Stage IA1 or IA2 is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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