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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

2. september 2026 oppdatert av: MediLink Therapeutics (Suzhou) Co., Ltd.

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

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

320

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200127
        • Shanghai Jiaotong University School of Medicine
        • Ta kontakt med:
          • Study Coordinator

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Andre navn:
  • YL201, Tam-Peli
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
PFS by BICR
Tidsramme: 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
Tidsramme: Up to approximately 2 years
OS is defined as the time from randomization until death from any cause.
Up to approximately 2 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
PFS by investigator
Tidsramme: Up to approximately 2 year
PFS per RECIST v1.1, as assessed by Investigator
Up to approximately 2 year
ORR
Tidsramme: Up to approximately 2 years
Objective Response Rate (ORR), as assessed by BICR and Investigator
Up to approximately 2 years
DCR
Tidsramme: Up to approximately 2 years
Disease Control Rate (DCR), as assessed by BICR and Investigator
Up to approximately 2 years
DoR
Tidsramme: Up to approximately 2 years
Duration of Response (DoR), as assessed by BICR and Investigator
Up to approximately 2 years
TTR
Tidsramme: Up to approximately 2 years
Time to Response (TTR), as assessed by BICR and Investigator
Up to approximately 2 years
Adverse Event
Tidsramme: 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
Tidsramme: Up to approximately 2 years
Up to approximately 2 years
To evaluate the Cmax
Tidsramme: Up to approximately 2 years
Up to approximately 2 years
To evaluate the Ctrough
Tidsramme: Up to approximately 2 years
Up to approximately 2 years
To evaluate the CL
Tidsramme: Up to approximately 2 years
Up to approximately 2 years
To evaluate the Vd
Tidsramme: Up to approximately 2 years
Up to approximately 2 years
To evaluate the t1/2
Tidsramme: Up to approximately 2 years
Up to approximately 2 years
Immunogenicity
Tidsramme: Up to approximately 2 years
Incidence of anti-drug antibodies of YL201
Up to approximately 2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. januar 2029

Studiet fullført (Antatt)

1. mai 2029

Datoer for studieregistrering

Først innsendt

31. august 2026

Først innsendt som oppfylte QC-kriteriene

2. september 2026

Først lagt ut (Faktiske)

4. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

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