A Multicenter, Open-label, Phase II Umbrella Study to Evaluate the Efficacy and Safety of the Investigational Product in Participants With Advanced or Metastatic Pancreatic Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • SKB571

    Drug

    q3w

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Cohort A: SKB571 monotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

ORR as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Time frame
Up to approximately 24 months.

Secondary outcomes

1

Progression-free survival (PFS)

Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.

Time frame
Up to approximately 24 months.
2

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.

Time frame
Up to approximately 24 months.
3

Disease control rate (DCR)

Assessed by the investigators as per RECIST v1.1

Time frame
Up to approximately 24 months.
4

Overall Survival (OS)

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

Time frame
Up to approximately 24 months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: