A Phase II Study of Neoadjuvant Sacituzumab Tirumotecan in Combination With Iparomlimab and Tuvonralimab in Locally Advanced Cervical Cancer

NCT07348861 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: B2025-751-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Cervical Cancer

Keywords

Locally advanced cervical cancer; cervical cancer stage IB3 (FIGO2018); cervical cancer stage IIA2 (FIGO2018); tumor size ≥ 4 cm cervical cancer stage IIIc1r (FIGO2018)

Outcome Measures

Primary Outcomes (1)

• Rate of pathological complete response

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

Sacituzumab tirumotecan plus Iparomlimab

EXPERIMENTAL

Drug: Sacituzumab tirumotecan plus Iparomlimab

Interventions

Sacituzumab tirumotecan plus Iparomlimab DRUG

Sacituzumab tirumotecan 5mg/kg iv. drip,Q2W Iparomlimab and Tuvonralimab 3mg/kg iv.drip, Q2W

Sacituzumab tirumotecan plus Iparomlimab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ;
• Subjects must agree to provide sufficient tumor tissue samples for PD-L1, TROP2 expression detection. This includes archived tumor samples (paraffin blocks or untainted sections in quantity that meet the testing requirements specified by this institute); without archived tumor tissue samples, subjects agree to undergo tumor lesion rebiometry.

You may not qualify if:

• 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 ;
• Those with an active tuberculosis infection history within 1 year prior to group admission ;
• Patients with other malignancies within 5 years of group entry, except for any previously cured type of in situ carcinoma and cured skin basal-cell carcinoma or skin scaly carcinoma ;
• Previously received exogenous hematopoietic stem cell or solid organ transplantation ;
• Those with a history of gastrointestinal perforation or who underwent excessive surgical surgery (excluding baseline tumor biopsies) or who suffered severe trauma, active ulcers, intestinal perforation, intestinal obstruction, and unhealed fractures within the first 4 weeks of study treatment ;
• Has a history of alcoholism, drug use or drug abuse within the past 1 year ;

Sponsors & Collaborators

• Zheng Min: lead
• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: collaborator
• Qilu Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Baoyue Pan

CONTACT

+8602087343104; panby@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Profeesor

Model Details: Sacituzumab tirumotecan, 5mg/kg iv. drip，Q2W Iparomlimab and Tuvonralimab, 3mg/kg iv.drip, Q2W

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 16, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)