The purpose of this study is to evaluate the safety and efficacy of an investigational B7-H3 antibody drug-conjugate administered as monotherapy, compared with standard of care (SOC) chemotherapy in metastatic pancreatic cancer patients who have failed prior Gemcitabine-based systemic therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
Drug: Tambotatug pelitecan 2.0mg/kg (maximum 200mg) Intravenous infusion Every 3 weeks Treatment will continue until disease progression or unacceptable toxicity.
Liposomal irinotecan Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity.
5 Fluorouracil Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity.
Leucovorin Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity.
Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
PFS by BICR
Progression-free Survival (PFS) is assessed by Blinded Independent Central Review(BICR) per response evaluation criteria in solid tumors (RECIST) v1.1
Time frame: Up to approximately 2 years
OS
OS is defined as the time from randomization until death from any cause.
Time frame: Up to approximately 2 years
PFS by investigator
PFS per RECIST v1.1, as assessed by Investigator
Time frame: Up to approximately 2 year
ORR
Objective Response Rate (ORR), as assessed by BICR and Investigator
Time frame: Up to approximately 2 years
DCR
Disease Control Rate (DCR), as assessed by BICR and Investigator
Time frame: Up to approximately 2 years
DoR
Duration of Response (DoR), as assessed by BICR and Investigator
Time frame: Up to approximately 2 years
TTR
Time to Response (TTR), as assessed by BICR and Investigator
Time frame: Up to approximately 2 years
Adverse Event
The incidence and severity of AEs, SAEs and AESIs per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0
Time frame: Up to approximately 2 years
To evaluate the AUC
Time frame: Up to approximately 2 years
To evaluate the Cmax
Time frame: Up to approximately 2 years
To evaluate the Ctrough
Time frame: Up to approximately 2 years
To evaluate the CL
Time frame: Up to approximately 2 years
To evaluate the Vd
Time frame: Up to approximately 2 years
To evaluate the t1/2
Time frame: Up to approximately 2 years
Immunogenicity
Incidence of anti-drug antibodies of YL201
Time frame: Up to approximately 2 years
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