- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07803783
A Study to Compare the Efficacy and Safety of YL201 With Standard Chemotherapy in Patients With Metastatic Pancreatic Cancer After Failure of Gemcitabine-Based Systemic Chemotherapy
A Randomized, Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of YL201 Versus Liposomal Irinotecan in Combination With 5-Fluorouracil/Leucovorin in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Failed Prior Gemcitabine-based Systemic Therapy
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: MediLink Study Team
- Telefonnummer: +86 512 62858368
- E-post: clinicaltrials@medilinkthera.com
Studieorter
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200127
- Shanghai Jiaotong University School of Medicine
-
Kontakt:
- Study Coordinator
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Participants must voluntarily sign a written informed consent form (ICF) and be willing and able to comply with protocol requirements.
- Participants must be ≥18 and ≤75 years of age.
- Participants must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Participants must have a life expectancy of at least 3 months.
- Participants must have histologically or cytologically confirmed incurable metastatic pancreatic ductal adenocarcinoma (PDAC).
- Participants must have received and failed only one prior line of gemcitabine-based systemic therapy.
- Participants must have at least one measurable lesion according to RECIST v1.1.
- Participants must have adequate organ function as defined in the protocol.
- Participants must agree to follow the contraception requirements specified in the protocol.
Exclusion Criteria:
- Participants with another malignancy within 5 years before randomization.
- Participants with pathologically confirmed pancreatic cancer other than PDAC.
- Participants who have previously received B7-H3-targeted therapy.
- Participants who have previously received topoisomerase I inhibitor or antibody-drug conjugate containing topoisomerase I inhibitor.
- 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.
- 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.
- 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.
- 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.
- 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.
- Participants with unresolved toxicity from prior anticancer therapy that has not recovered to the level specified in the protocol.
- Participants with known hypersensitivity to any component of the study treatment, or a history of severe hypersensitivity reactions or severe infusion-related reactions.
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Tambotatug pelitecan
Tambotatug pelitecan, monotherapy
|
Drug: Tambotatug pelitecan 2.0mg/kg (maximum 200mg) Intravenous infusion Every 3 weeks Treatment will continue until disease progression or unacceptable toxicity.
Andra namn:
|
|
Aktiv komparator: Chemotherapy
Active comparator: nal-IRI+5-FU/LV
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PFS by BICR
Tidsram: 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
|
Up to approximately 2 years
|
|
OS
Tidsram: Up to approximately 2 years
|
OS is defined as the time from randomization until death from any cause.
|
Up to approximately 2 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PFS by investigator
Tidsram: Up to approximately 2 year
|
PFS per RECIST v1.1, as assessed by Investigator
|
Up to approximately 2 year
|
|
ORR
Tidsram: Up to approximately 2 years
|
Objective Response Rate (ORR), as assessed by BICR and Investigator
|
Up to approximately 2 years
|
|
DCR
Tidsram: Up to approximately 2 years
|
Disease Control Rate (DCR), as assessed by BICR and Investigator
|
Up to approximately 2 years
|
|
DoR
Tidsram: Up to approximately 2 years
|
Duration of Response (DoR), as assessed by BICR and Investigator
|
Up to approximately 2 years
|
|
TTR
Tidsram: Up to approximately 2 years
|
Time to Response (TTR), as assessed by BICR and Investigator
|
Up to approximately 2 years
|
|
Adverse Event
Tidsram: 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
|
Up to approximately 2 years
|
|
To evaluate the AUC
Tidsram: Up to approximately 2 years
|
Up to approximately 2 years
|
|
|
To evaluate the Cmax
Tidsram: Up to approximately 2 years
|
Up to approximately 2 years
|
|
|
To evaluate the Ctrough
Tidsram: Up to approximately 2 years
|
Up to approximately 2 years
|
|
|
To evaluate the CL
Tidsram: Up to approximately 2 years
|
Up to approximately 2 years
|
|
|
To evaluate the Vd
Tidsram: Up to approximately 2 years
|
Up to approximately 2 years
|
|
|
To evaluate the t1/2
Tidsram: Up to approximately 2 years
|
Up to approximately 2 years
|
|
|
Immunogenicity
Tidsram: Up to approximately 2 years
|
Incidence of anti-drug antibodies of YL201
|
Up to approximately 2 years
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
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Andra studie-ID-nummer
- TAISHAN-305
Läkemedels- och apparatinformation, studiedokument
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