NCT07348861
Not yet recruiting
Phase 2
A Phase II, Prospective, Single-Arm, Multicenter, Open-Label Study of Sacituzumab Tirumotecan in Combination With Iparomlimab and Tuvonralimab as Neoadjuvant Therapy for Locally Advanced Cervical Cancer
Zheng Min1 site in 1 country25 target enrollmentStarted: February 1, 2026Last updated:
InterventionsSacituzumab tirumotecan plus Iparomlimab
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Zheng Min
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Rate of pathological complete response
Overview
Brief Summary
This is a phase II, prospective, single-arm, multicenter, open-label study to evaluate the efficacy and safety of sacituzumab tirumotecan in combination with iparomlimab and tuvonralimab as neoadjuvant therapy in patients with locally advanced cervical cancer
Detailed Description
The goal of this clinical trial is to learn if Sacituzumab tirumotecan plus Iparomlimab and Tuvonralimab works to treat locally advanced cervical cancer. It will also learn about the safety of the combination of these two drugs. The main questions it aims to answer are:
- Does Sacituzumab tirumotecan plus Iparomlimab and Tuvonralimab increase the rate of pathological complete response?
- What medical problems do participants have when treating Sacituzumab tirumotecan plus Iparomlimab and Tuvonralimab? Researchers will calculate the rate of pathological complete response and collect the adverse events to see the efficacy and safety of Sacituzumab tirumotecan plus Iparomlimab and Tuvonralimab in locally advanced cervical cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Voluntary participation in the clinical study; complete understanding, knowledge of this study and signing informed consent; willingness to follow and ability to complete all trial procedures;
- •Histopathology confirmed cervical scaly carcinoma, adenocarcinoma, and adenocarcinoma. If there are small cell carcinomas, neuroendocrine carcinomas, and sarcoma components, they cannot be grouped ;
- •Locally advanced cervical cancer, according to FIGO2018 stage, conforming to stage IIB/IIIc1r with IB3, IIA2, and tumor diameter ≥ 4 cm;
- •Has not previously received any other anti-tumor treatment ;
- •Age 18-65 years ;
- •The physical fitness score of the Eastern U.S. Oncology Cooperation Group (ECOG) was 0 to 1 score ;
- •Life expectancy exceeds 3 months ;
- •Organ function and hematopoietic function must meet the following requirements:
- •Hemoglobin (HGB) ≥80g/L; Leukocyte count (WBC) ≥ 3×109/L; absolute neutrophil count (ANC) ≥ 1.5 × 109/L ; Platelet count (PLT) ≥80×109/L; Total cholugin (TBIL) ≤ 1.5 × normal value upper limit (ULN) ; aspartate transaminase AST) and aspartate transaminase (ALT) ≤ 2.5 × ULN ; If hepatic dysfunction is caused by tumor hepatic metastasis, AST and ALT ≤ 5 × ULN ; Serum creatinine (Cr) ≤ 1.5 × ULN; or creatinine clearance rate (CrCl) ≥ 50 mL/min; International standardized ratio (INR) or plasma coagulase prime time (PT) ≤ 1.5 × ULN.
- •Female subjects in childbearing age must agree to effective contraception measures within 5 months after signing a informed consent form, during the study period, and after the last administration of the drug ;
Exclusion Criteria
- •Research treatments that have begun to receive other anti-tumor treatments (including chemotherapy, molecular targeting therapy, radiotherapy, immunotherapy, monoclonal antibody therapy), or that have participated in other non-marketing drug clinical studies ;
- •Subjects known to have previously been allergic to macromolecular protein preparations / monoclonal antibodies, or known to be allergic to the composition of any experimental drug ;
- •pregnant or breastfeeding women ;
- •Those with active autoimmune diseases and who have received systematic treatment (such as corticosteroids or immunosuppressive drugs) within the past 2 years (such as, but not limited to: meningitis, enteritis, hepatitis, pituitary, vascular, nephritis, hyperthyroidism, hypothyroidism \[inclusive for non-clinical symptomatic hypothyroidism or hypothyroidism due to chemotherapy\]; those with vitiligo or who had complete remission of asthma in childhood and need no intervention in adulthood;)
- •Whole-body corticosteroid (dosage equivalent to or greater than 10 mg/day strong pine) or other immunosuppressive drug therapists were required within 14 days prior to group admission or during the study period ;
- •Individuals who received live vaccination within 4 weeks of treatment initiation ;
- •Those who have received anti-tumor vaccines, or those who have received anti-tumor therapies with systemic immunostimulatory effects ;
- •With serious medical conditions, such as severe infections, uncontrollable diabetes, cardiovascular disease (classified by the New York Heart Association as Class III or IV heart failure, cardiovascular obstruction above Class II, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc.) or pulmonary disease (history of interstitial pneumonia, obstructive pulmonary disease, and symptomatic Bronchospasm);
- •Hepatitis C virus deoxyribonucleic acid (HBV DNA) \> 103 copies/ml positive for hepatitis C surface antigen (HBsAg) and/or hepatitis C core antibody (HBcAb), or hepatitis C virus antibody positive; syphilis positive;
- •Has a history of human immunodeficiency virus infection, or has other acquired, congenital immunodeficiency diseases ;
Arms & Interventions
Sacituzumab tirumotecan plus Iparomlimab
Experimental
Intervention: Sacituzumab tirumotecan plus Iparomlimab (Drug)
Outcomes
Primary Outcomes
Rate of pathological complete response
Time Frame: From enrollment to the end of treatment at 8 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Zheng Min
Profeesor
Sun Yat-sen University
Study Sites (1)
Loading locations...
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