Metastatic Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma (PDAC)
Conditions
Keywords
YL201, Tambotatug pelitecan, Tam-Peli, PDAC
Brief summary
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.
Interventions
DRUGTambotatug pelitecan
Drug: Tambotatug pelitecan 2.0mg/kg (maximum 200mg) Intravenous infusion Every 3 weeks Treatment will continue until disease progression or unacceptable toxicity.
DRUGLiposomal irinotecan
Liposomal irinotecan Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity.
DRUG5 Fluorouracil
5 Fluorouracil Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity.
DRUGLeucovorin
Leucovorin Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity.
Sponsors
MediLink Therapeutics (Suzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Participants must voluntarily sign a written informed consent form (ICF) and be willing and able to comply with protocol requirements. 2. Participants must be ≥18 and ≤75 years of age. 3. Participants must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 4. Participants must have a life expectancy of at least 3 months. 5. Participants must have histologically or cytologically confirmed incurable metastatic pancreatic ductal adenocarcinoma (PDAC). 6. Participants must have received and failed only one prior line of gemcitabine-based systemic therapy. 7. Participants must have at least one measurable lesion according to RECIST v1.1. 8. Participants must have adequate organ function as defined in the protocol. 9. Participants must agree to follow the contraception requirements specified in the protocol.
Exclusion criteria
1. Participants with another malignancy within 5 years before randomization. 2. Participants with pathologically confirmed pancreatic cancer other than PDAC. 3. Participants who have previously received B7-H3-targeted therapy. 4. Participants who have previously received topoisomerase I inhibitor or antibody-drug conjugate containing topoisomerase I inhibitor. 5. Participants who are concurrently enrolled in another clinical study, unless it is an observational, non-interventional study or the participant is in the follow-up period of an interventional study. 6. Participants who have not met the protocol-specified washout requirements for prior systemic therapy, relevant concomitant medications, radiotherapy, or surgery before randomization, or who have not adequately recovered from prior surgery or are planning to undergo major surgery during the study. 7. Participants with protocol-specified exclusionary conditions related to central nervous system (CNS) metastases, history of transplantation, immunosuppressive therapy, live vaccine administration, or autoimmune or inflammatory diseases. 8. Participants with uncontrolled or clinically significant concomitant diseases, including serious gastrointestinal, cardiovascular or cerebrovascular, pulmonary, thromboembolic, bleeding-related, effusion-related, or ascites-related safety risks. 9. Participants with recent serious infection, active infection, active tuberculosis or syphilis, HIV positivity or immunodeficiency, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 10. Participants with unresolved toxicity from prior anticancer therapy that has not recovered to the level specified in the protocol. 11. Participants with known hypersensitivity to any component of the study treatment, or a history of severe hypersensitivity reactions or severe infusion-related reactions. 12. Participants who are pregnant or breastfeeding, planning to become pregnant or breastfeed, or who have any other medical, psychiatric, social, or compliance-related factors that, in the investigator's opinion, would make them unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS by BICR | Up to approximately 2 years | Progression-free Survival (PFS) is assessed by Blinded Independent Central Review（BICR） per response evaluation criteria in solid tumors (RECIST) v1.1 |
| OS | Up to approximately 2 years | OS is defined as the time from randomization until death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS by investigator | Up to approximately 2 year | PFS per RECIST v1.1, as assessed by Investigator |
| ORR | Up to approximately 2 years | Objective Response Rate (ORR), as assessed by BICR and Investigator |
| DCR | Up to approximately 2 years | Disease Control Rate (DCR), as assessed by BICR and Investigator |
| DoR | Up to approximately 2 years | Duration of Response (DoR), as assessed by BICR and Investigator |
| TTR | Up to approximately 2 years | Time to Response (TTR), as assessed by BICR and Investigator |
| Adverse Event | Up to approximately 2 years | 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 |
| To evaluate the AUC | Up to approximately 2 years | — |
| To evaluate the Cmax | Up to approximately 2 years | — |
| To evaluate the Ctrough | Up to approximately 2 years | — |
| To evaluate the CL | Up to approximately 2 years | — |
| To evaluate the Vd | Up to approximately 2 years | — |
| To evaluate the t1/2 | Up to approximately 2 years | — |
| Immunogenicity | Up to approximately 2 years | Incidence of anti-drug antibodies of YL201 |
Countries
China
Contacts
CONTACTMediLink Study Team
Outcome results
None listed