AzTrials
AzTrials

Cervical CancerPhase 2NCT07256236

SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer

A Phase 2 study testing Sacituzumab tirumotecan and QL1706 in people with Cervical Cancer, run by Fujian Cancer Hospital at 14 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a prospective, single arm II clinical trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (SKB264) and QL1706 in the treatment of recurrent or metastatic cervical cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Sacituzumab tirumotecan and QL1706
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
14 sitesChina
Study dates
28 Jan 2026to 15 Dec 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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female, aged ≥18 years at the time of signing the informed consent form;
  • Diagnosed with recurrent or metastatic cervical cancer [pathological types include squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma, etc., with pathological report provided], and not suitable for radical treatments such as surgery or radiotherapy. Patients will be divided into the following two cohorts based on pathological type:
  • Cohort 1: Cervical squamous cell carcinoma;
  • Cohort 2: Cervical non-squamous carcinoma (including adenocarcinoma or adenosquamous carcinoma, and other types of cervical cancer)
  • Have experienced failure of at least one prior line of platinum-based standard therapy or intolerance to platinum-based drugs in the recurrent or metastatic setting, or have experienced radiologically confirmed disease progression during or within 6 months after completion (≥4 cycles) of platinum-based neoadjuvant or adjuvant chemotherapy. Specific requirements are as follows:
  • Failure of first-line platinum-based standard therapy: meeting any one of the following criteria: i. Radiologically confirmed disease progression during treatment; ii. Radiologically confirmed disease progression after completion of treatment, provided the patient had a response (Complete Response (CR)/Partial Response (PR)/Stable Disease (SD)) and received ≥4 cycles of treatment; (b) Investigator's judgment that the subject is intolerant to platinum-based drugs; (c) Radiologically confirmed disease progression during or within 6 months after completion (≥4 cycles) of platinum-based neoadjuvant or adjuvant chemotherapy. Weekly chemotherapy administered concurrently with radiotherapy for sensitization purposes should not be counted as chemotherapy cycles;
Show all 18Show fewer
  • According to RECIST (v1.1) criteria, at least one measurable lesion (non-lymph node lesion with longest diameter ≥10 mm, or lymph node lesion with short diameter ≥15 mm). Lesions previously irradiated should not be selected as target lesions; unless there are no other measurable lesions available, in which case a previously irradiated measurable lesion that has shown confirmed progression radiologically may be selected as a target lesion. Subjects with only skin lesions or bone lesions are not eligible;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to dosing;
  • Expected survival period ≥12 weeks;
  • Subjects must have recovered from all toxicities resulting from prior therapy (i.e., improved to Grade 0 or 1, or to the level specified in the eligibility criteria), except for toxicities not considered a safety risk (such as alopecia, vitiligo, and other asymptomatic laboratory abnormalities). Subjects with ≤ Grade 2 neuropathy will be evaluated on a case-by-case basis in consultation with the investigator;
  • Adequate organ and bone marrow function (without transfusion, recombinant human thrombopoietin, or colony-stimulating factor therapy within 2 weeks prior to dosing), defined as follows:
  • Neutrophil count (NEUT#) ≥1.5×10⁹/L; Platelets (PLT) ≥100×10⁹/L; Hemoglobin ≥90 g/L;
  • Liver function: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 × ULN; for subjects with baseline liver metastases, ALT and AST ≤5 × ULN; Albumin ≥30 g/L; Total bilirubin (TBIL) ≤1.5 × ULN;
  • Renal function: Creatinine clearance (Ccr) ≥50 ml/min (calculated using the standard Cockcroft-Gault formula); Urine protein ≤1+; if urine protein ≥2+, then 24-hour urine protein quantification must be ≤1.0 g;
  • Coagulation function: International Normalized Ratio (INR), Activated Partial Thromboplastin Time (APTT), and Prothrombin Time (PT) ≤1.5 × ULN;
  • Cardiac left ventricular ejection fraction (LVEF) ≥50%.
  • For female subjects of childbearing potential, must agree to use effective medical contraception measures from the time of signing the informed consent form until 6 months after the last dose;
  • The subject voluntarily joins this study, signs the informed consent form, and is able to comply with the visits and related procedures stipulated in the protocol.

Who cannot join

  • Subjects who have had a known additional malignancy that is progressing or has required active treatment within the past 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, etc., that has undergone potentially curative therapy.
  • Subjects with known leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or other active central nervous system (CNS) metastases. Subjects with brain metastases treated with local therapy may be enrolled if they meet the following criteria: clinically stable for at least 4 weeks, and no requirement for steroid treatment for at least 14 days prior to the first dose of study drug.
  • Subjects with clinically significant cardiovascular diseases, such as: a) Presence of severe or uncontrolled cardiac disease or clinical symptoms requiring treatment within 6 months prior to the first study dose, including: congestive heart failure classified as New York Heart Association (NYHA) Class III or IV, unstable angina pectoris uncontrolled by medication, severe arrhythmia requiring drug treatment (except for atrial fibrillation or paroxysmal supraventricular tachycardia), and myocardial infarction; b) Previous history of myocarditis or cardiomyopathy; c) QTc interval > 480 ms based on baseline measurement.
  • Subjects with severe and/or uncontrolled concurrent diseases, such as decompensated liver cirrhosis, nephrotic syndrome, uncontrolled hypertension or severe hypertension, clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Subjects diagnosed with active Hepatitis B or Hepatitis C.
  • Subjects with known poorly controlled human immunodeficiency virus (HIV) infection, including HIV infection with a history of Kaposi's sarcoma and/or multicentric Castleman's disease.
Show all 24Show fewer
  • Subjects with known active tuberculosis.
  • Subjects with a history of severe dry eye syndrome, meibomian gland dysfunction, blepharitis, or corneal diseases that affect timely corneal healing.
  • Subjects with a known prior history of fistula of the female reproductive tract (e.g., vesicovaginal fistula, urethrovaginal fistula, vesicocervical fistula, etc.); subjects may be enrolled if the perforation or fistula has been treated with diversion surgery, resection, or repair, and the disease is considered by the investigator to have recovered or resolved.
  • Subjects who have undergone major surgery (as defined by the investigator) within 30 days prior to the first dose of study treatment or have not recovered from prior surgery.
  • Subjects with known allergy or hypersensitivity to the study drug or excipients; history of severe hypersensitivity to monoclonal antibodies.
  • Subjects with a history of interstitial lung disease (ILD), or history of non-infectious pneumonitis requiring steroid treatment, or current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging during screening.
  • Subjects with a history of allogeneic tissue/organ transplantation.
  • Subjects with autoimmune disease that required systemic treatment within the past 2 years or requires immunosuppressive therapy during the study period. Subjects with controlled Type 1 diabetes, thyroiditis with normal thyroid function, hypothyroidism controlled well with hormone replacement therapy (HRT), or skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis) can be enrolled.
  • Subjects who have previously received TROP2-targeted therapy, or any drug containing a topoisomerase I inhibitor, including antibody-drug conjugate (ADC) therapy.
  • Subjects who have previously used any experimental anticancer vaccine, or any drug targeting T-cell co-stimulation pathways.
  • Administration of a live vaccine within 30 days prior to the first dose of study treatment, or planned administration of a live vaccine during the study.
  • Requirement for strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks prior to the first dose of study treatment or during the study.
  • Received any chemotherapy, radiotherapy, immunotherapy, or biologic therapy within 4 weeks prior to the first dose of study treatment; received small molecule tyrosine kinase inhibitors (TKIs), antitumor hormone therapy, systemic immunostimulants (including but not limited to interferon, IL-2), or Chinese herbal patent medicines with approved anti-tumor indications within 2 weeks prior to the first dose of study treatment.
  • Received palliative radiotherapy to known metastatic sites within 2 weeks prior to the first dose of study treatment.
  • Received systemic anti-infection therapy within 1 week prior to the first dose of study treatment.
  • Any condition requiring systemic corticosteroid therapy (at doses >10 mg/day prednisolone or equivalent dose of similar drugs) or other immunosuppressive therapy within 14 days prior to the first dose of study treatment. However, subjects using intranasal, inhaled, topical, or local corticosteroid injections (e.g., intra-articular injection), or using corticosteroids as premedication for hypersensitivity reactions can be enrolled.
  • Women who are pregnant or breastfeeding.
  • Any condition that, in the investigator's judgment, interferes with the evaluation of the study drug, the subject's safety, or the interpretation of study results, or any other circumstance that the investigator considers inappropriate for participation in this study.

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Qin Xu, Ph.D contact

0591-0-62752366

xuqin@fjmu.edu.cn

14 sites in 1 country

China14 sites, 14 recruiting

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116027

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350011

    Qin Xu, +86-13950419396, 1379423879@qq.com

    Recruiting

  • Fujian Medical University Affiliated Second Hospital

    Fuzhou, Fujian, 362000

    Not yet recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

    Not yet recruiting

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010030

    Not yet recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Not yet recruiting

  • The Second Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Not yet recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong, 250013

    Not yet recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

    Not yet recruiting

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272113

    Zhu Qiao

    Not yet recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530213

    Not yet recruiting

  • Qilu Hospital of Shandong University(Qingdao)

    Qingdao, Shandong, 266011

    Not yet recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030013

    Not yet recruiting

  • Zhangzhou Affiliated Hospital of Fujian Medical University

    Zhangzhou, Fujian, 363000

    Yanhong Zhuo, zhuoyanhong928@163.com

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Multicenter, Phase II Study of Sacituzumab Tirumotecan (Sac-TMT/SKB264) in Combination With QL1706 for Recurrent or Metastatic Cervical Cancer

This study is a prospective, single arm II clinical trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (SKB264) and QL1706 in the treatment of recurrent or metastatic cervical cancer.

Read the detailed description

Cervical cancer (CC) is a major global health concern. Current second-line options, including single-agent chemotherapy or PD-1/L1 inhibitors, provide limited benefit, with objective response rates (ORR) of only 5-29%. Patients with cervical adenocarcinoma, which constitutes 20-25% of cases, often have a poorer prognosis, and no specific treatments are recommended for this subtype.

QL1706, a novel dual anti-PD-1/CTLA-4 antibody, has been approved in China for the second-line treatment of CC. Separately, TROP2 is highly expressed in 88.7% of CC and is associated with poor prognosis. Sac-TMT, a TROP2-directed ADC, combined with an anti-PD-1 agent showed a promising ORR of 57.9% in a phase II study, without new safety signals.

Based on the unique mechanisms of action of Sac-TMT and QL1706, as well as the existing research data, their combination is expected to provide a better second-line treatment option for recurrent or metastatic CC. Therefore, we are applying to conduct this Phase II, multicenter, single-arm clinical study to evaluate the efficacy and safety of Sac-TMT in combination with QL1706 for the treatment of recurrent or metastatic CC, in order to improve clinical benefits for patients.

Conditions
Cervical Cancer
Being tested
Sacituzumab tirumotecan, QL1706
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 tirumotecanDrug

    Also called SKB264, Sac-TMT, MK-2870

    intravenous (IV) infusion (4mg/kg, Q2W)

  • QL1706Drug

    intravenous (IV) infusion (3mg/kg, Q2W). Continuous administration will be maintained until radiological disease progression, occurrence of intolerable toxicity, the participant requests to discontinue treatment, or other treatment discontinuation criteria specified in the protocol are met (whichever occurs first). The maximum duration of administration for QL1706 is 24 months.

Study groups in NCT07256236
Study groupRoleWhat they receive
SKB264+QL1706ExperimentalNot described
Receives: Drug: Sacituzumab tirumotecan; Drug: QL1706

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed investigator per RECIST 1.1

    Measured: Up to approximately 24 months

Secondary outcomes (5)

  1. Overall Survival(OS)

    Time from start of treatment to death due to any cause.

    Measured: From treatment administration up to a maximum duration of 24 months.

  2. Progression Free Survival(PFS)

    The time from the beginning of the patient's treatment to the disease progression per RECIST 1.1 based on investigator or death due to any cause, whichever occurs first.

    Measured: From treatment administration up to a maximum duration of 24 months.

  3. Duration of Response(DoR)

    DoR is defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by investigator or death due to any cause, whichever occurs first.

    Measured: Through study completion, an expected average of 24 months.

  4. Disease Control Rate (DCR)

    DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by investigator per RECIST 1.1

    Measured: From treatment administration up to a maximum duration of 24 months.

  5. Percentage of Participants With Adverse Events (AEs)

    Number of participants with adverse events (AEs) according to CTCAE 5.0

    Measured: Up to approximately 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2025
  2. Study start28 Jan 2026
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion15 Dec 2028 (estimated)

Resources

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
Masking
None (open label)
Enrolment
89 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07256236
Sponsor's protocol ID
SHINE
Status last verified
Mar 2026
First submitted
20 Nov 2025
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab tirumotecan and QL1706 in people with Cervical Cancer, run by Fujian Cancer Hospital at 14 sites 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 18 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites 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 Qin Xu, Ph.D (0591-0-62752366, xuqin@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07256236.

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 30 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in