About this trial
This is a multicenter, open-label, Phase II umbrella study conducted in participants with advanced or metastatic pancreatic cancer. This study has set up different cohorts to evaluate the efficacy and safety of multiple investigational products in pancreatic cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form.
Histologically or cytologically confirmed advanced or metastatic pancreatic cancer.
Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 7 days before the first dose.
Disqualifiers
History or current metastases to central nervous system.
Histologically or cytologically confirmed other pathological types or differentiation combined with other pathological types.
Subjects with other malignant tumors within 3 years prior to the first dose.
Presence of any cardiovascular and cerebrovascular disorders or risk factors.
Trial design
Single group
Treatments tested in this trial
SKB571
Drugq3w
Treatment groups
Trial outcomes
Primary outcomes
Objective response rate (ORR)
ORR as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Secondary outcomes
Progression-free survival (PFS)
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
Duration of Response (DOR)
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Disease control rate (DCR)
Assessed by the investigators as per RECIST v1.1
Overall Survival (OS)
Time from start of treatment to death due to any reason.
Locations
Sponsors and contacts
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