SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer
ConditionCervical Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFujian Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female, aged ≥18 years at the time of signing the informed consent form;
Cohort 1: Cervical squamous cell carcinoma;
Cohort 2: Cervical non-squamous carcinoma (including adenocarcinoma or adenosquamous carcinoma, and other types of cervical cancer)
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;
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Sacituzumab tirumotecan
Drugintravenous (IV) infusion (4mg/kg, Q2W)
QL1706
Drugintravenous (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.
Treatment groups
89 Participants
are divided into 1 treatment groupGroup A: SKB264+QL1706Experimental treatment 2 interventions
Trial outcomes
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
Time frame
Up to approximately 24 monthsSecondary outcomes
1
Overall Survival(OS)
Time from start of treatment to death due to any cause.
Time frame
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.
Time frame
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.
Time frame
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
Time frame
From treatment administration up to a maximum duration of 24 months.Sponsors and contacts
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Source ClinicalTrials.gov