SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer

NCT07256236 | Recruiting Phase 2

• 1 other identifier: SHINE
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (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

  Up to approximately 24 months

Secondary Outcomes (5)

• Overall Survival(OS)

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

• Progression Free Survival(PFS)

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

• Duration of Response(DoR)

  Through study completion, an expected average of 24 months.

• Disease Control Rate (DCR)

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

• Percentage of Participants With Adverse Events (AEs)

  Up to approximately 24 months.

Study Arms (1)

SKB264+QL1706

EXPERIMENTAL

Drug: Sacituzumab tirumotecan; Drug: QL1706

Interventions

Sacituzumab tirumotecan DRUG

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

Also known as: SKB264, Sac-TMT, MK-2870

SKB264+QL1706

QL1706 DRUG

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.

SKB264+QL1706

Eligibility Criteria

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

You may qualify if:

• 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:
• (a) 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;
• 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;

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (14)

Fujian Cancer Hospital

Fuzhou, Fujian, 350011, China

RECRUITING

Fujian Medical University Affiliated Second Hospital

Fuzhou, Fujian, 362000, China

NOT YET RECRUITING

Zhangzhou Affiliated Hospital of Fujian Medical University

Zhangzhou, Fujian, 363000, China

RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

NOT YET RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530213, China

NOT YET RECRUITING

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010030, China

NOT YET RECRUITING

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116027, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

NOT YET RECRUITING

The Second Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

NOT YET RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, 250013, China

NOT YET RECRUITING

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Affiliated Hospital of Jining Medical University

Jining, Shandong, 272113, China

NOT YET RECRUITING

Qilu Hospital of Shandong University(Qingdao)

Qingdao, Shandong, 266011, China

NOT YET RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030013, China

NOT YET RECRUITING

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

Qin Xu, Ph.D

CONTACT

0591-0-62752366; xuqin@fjmu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14)