Cervical CancerPhase 2NCT07348861
A Phase II Study of Neoadjuvant Sacituzumab Tirumotecan in Combination With Iparomlimab and Tuvonralimab in Locally Advanced Cervical Cancer
A Phase 2 study testing Sacituzumab tirumotecan plus Iparomlimab in people with Cervical Cancer, run by Zheng Min at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Sacituzumab tirumotecan plus Iparomlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 Jan 2028
- Phase
- Phase 2
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ;
Show all 11Show fewer
- 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.
Who cannot join
- 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 ;
Show all 20Show fewer
- 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 ;
- Having a clear history of neurological or mental disorders, such as epilepsy, dementia, and dependence disorder;
- Other severe, acute, or chronic diseases or laboratory abnormalities that may increase the risk of participation in studies and study drug use, or may interfere with the interpretation of study results ;
- People with previous eye surface disorders, e.g.: dry eye disease, corneal inflammation, etc. conditions ;
- The presence of a relative or absolute taboo condition for abdominal cervical cancer surgery ;
- Researchers consider participants unsuitable for this study due to other reasons.
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Baoyue Pan, +8602087343104, panby@sysucc.org.cn
About this study
Official title: 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
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
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Sacituzumab tirumotecan plus Iparomlimab
- Keywords
- Locally advanced cervical cancer, cervical cancer stage IB3 (FIGO2018), cervical cancer stage IIA2 (FIGO2018), tumor size ≥ 4 cm cervical cancer stage IIIc1r (FIGO2018)
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab tirumotecan plus IparomlimabDrug
Sacituzumab tirumotecan 5mg/kg iv. drip,Q2W Iparomlimab and Tuvonralimab 3mg/kg iv.drip, Q2W
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab tirumotecan plus Iparomlimab | Experimental | Not described Receives: Drug: Sacituzumab tirumotecan plus Iparomlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pathological complete response
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Sacituzumab tirumotecan, 5mg/kg iv. drip，Q2W Iparomlimab and Tuvonralimab, 3mg/kg iv.drip, Q2W
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zheng Min
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zheng Min, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348861
- Sponsor's protocol ID
- B2025-751-01
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: ICMJE
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07348861
- Acronym / sponsor ID
- B2025-751-01
- 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)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Zheng MinUniversity, hospital or other
- Collaborators
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Qilu Pharmaceutical Co., Ltd.
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 16 Jan 2026 (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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sacituzumab tirumotecan, 5mg/kg iv. drip，Q2W Iparomlimab and Tuvonralimab, 3mg/kg iv.drip, Q2W
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab tirumotecan plus Iparomlimab | Experimental | Drug: Sacituzumab tirumotecan plus Iparomlimab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 ;
Key exclusion criteria (20 listed)
- 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 ;
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 |
|---|---|---|
| Sacituzumab tirumotecan plus IparomlimabSacituzumab tirumotecan 5mg/kg iv. drip,Q2W Iparomlimab and Tuvonralimab 3mg/kg iv.drip, Q2W | Drug | Sacituzumab tirumotecan plus Iparomlimab |
Primary outcome
Rate of pathological complete response
Time frame: From enrollment to the end of treatment at 8 weeks
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 16 Jan 2026.
- Individual participant dataSharing planned: Yes. ICMJE
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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 2 study testing Sacituzumab tirumotecan plus Iparomlimab in people with Cervical Cancer, run by Zheng Min 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 11 inclusion and 20 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: opening soon, as of the sponsor's last update on 16 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Baoyue Pan (+8602087343104, panby@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of pathological complete response (time frame: From enrollment to the end of treatment at 8 weeks). 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 16 Jan 2026.