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Metastatic Pancreatic CancerPhase 3NCT07803783

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 Phase 3 study testing Tambotatug pelitecan, Liposomal irinotecan and 5 Fluorouracil in people with Metastatic Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma (PDAC), run by MediLink Therapeutics (Suzhou) Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Tambotatug pelitecan, Liposomal irinotecan and 5 Fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
1 siteChina
Study dates
Oct 2026to May 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

MediLink Study Team contact

+86 512 62858368

clinicaltrials@medilinkthera.com

China1 site

  • Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200127

    Study Coordinator

Other trials in China

About this study

Official title: 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.

Being tested
Tambotatug pelitecan, Liposomal irinotecan, 5 Fluorouracil, Leucovorin
Keywords
YL201, Tambotatug pelitecan, Tam-Peli, PDAC
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tambotatug pelitecanDrug

    Also called YL201, Tam-Peli

    Drug: Tambotatug pelitecan

    2.0mg/kg (maximum 200mg)

    Intravenous infusion

    Every 3 weeks

    Treatment will continue until disease progression or unacceptable toxicity.

  • Liposomal irinotecanDrug

    Liposomal irinotecan

    Intravenous infusion

    Every 2 weeks

    Treatment will continue until disease progression or unacceptable toxicity.

  • 5 FluorouracilDrug

    5 Fluorouracil

    Intravenous infusion

    Every 2 weeks

    Treatment will continue until disease progression or unacceptable toxicity.

  • LeucovorinDrug

    Leucovorin

    Intravenous infusion

    Every 2 weeks

    Treatment will continue until disease progression or unacceptable toxicity.

Study groups in NCT07803783
Study groupRoleWhat they receive
Tambotatug pelitecanExperimentalTambotatug pelitecan, monotherapy
Receives: Drug: Tambotatug pelitecan
ChemotherapyActive comparatorActive comparator: nal-IRI+5-FU/LV
Receives: Drug: Liposomal irinotecan; Drug: 5 Fluorouracil; Drug: Leucovorin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to approximately 2 years

  2. OS

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

    Measured: Up to approximately 2 years

Secondary outcomes (13)

  1. PFS by investigator

    PFS per RECIST v1.1, as assessed by Investigator

    Measured: Up to approximately 2 year

  2. ORR

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

    Measured: Up to approximately 2 years

  3. DCR

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

    Measured: Up to approximately 2 years

  4. DoR

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

    Measured: Up to approximately 2 years

  5. TTR

    Time to Response (TTR), as assessed by BICR and Investigator

    Measured: Up to approximately 2 years

  6. 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

    Measured: Up to approximately 2 years

  7. To evaluate the AUC

    Measured: Up to approximately 2 years

  8. To evaluate the Cmax

    Measured: Up to approximately 2 years

  9. To evaluate the Ctrough

    Measured: Up to approximately 2 years

  10. To evaluate the CL

    Measured: Up to approximately 2 years

  11. To evaluate the Vd

    Measured: Up to approximately 2 years

  12. To evaluate the t1/2

    Measured: Up to approximately 2 years

  13. Immunogenicity

    Incidence of anti-drug antibodies of YL201

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJan 2029 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07803783
Sponsor's protocol ID
TAISHAN-305
Status last verified
Sep 2026
First submitted
31 Aug 2026
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tambotatug pelitecan, Liposomal irinotecan and 5 Fluorouracil in people with Metastatic Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma (PDAC), run by MediLink Therapeutics (Suzhou) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact MediLink Study Team (+86 512 62858368, clinicaltrials@medilinkthera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS by BICR (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07803783.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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