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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

ConditionsMetastatic Pancreatic CancerPancreatic Ductal Adenocarcinoma (PDAC)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMediLink Therapeutics (Suzhou) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tambotatug pelitecan

    Drug

    Drug: Tambotatug pelitecan 2.0mg/kg (maximum 200mg) Intravenous infusion Every 3 weeks Treatment will continue until disease progression or unacceptable toxicity.

  • Liposomal irinotecan

    Drug

    Liposomal irinotecan Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity.

  • 5 Fluorouracil

    Drug

    5 Fluorouracil Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity.

  • Leucovorin

    Drug

    Leucovorin Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity.

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Tambotatug pelitecanExperimental treatment 1 intervention
Group B: ChemotherapyActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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
2

OS

OS is defined as the time from randomization until death from any cause.

Time frame
Up to approximately 2 years

Secondary outcomes

1

PFS by investigator

PFS per RECIST v1.1, as assessed by Investigator

Time frame
Up to approximately 2 year
2

ORR

Objective Response Rate (ORR), as assessed by BICR and Investigator

Time frame
Up to approximately 2 years
3

DCR

Disease Control Rate (DCR), as assessed by BICR and Investigator

Time frame
Up to approximately 2 years
4

DoR

Duration of Response (DoR), as assessed by BICR and Investigator

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

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

MediLink Therapeutics (Suzhou) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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