ClinicalTrials.gg
Not yet recruitingNCT07803783Updated Sep 4, 2026

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 interventional study of Tambotatug pelitecan and Liposomal irinotecan in Metastatic Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma (PDAC), sponsored by MediLink Therapeutics (Suzhou) Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by MediLink Therapeutics (Suzhou) Co., Ltd. · Phase 3, Interventional, and Treatment

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 3
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 629 studies in Pancreatic Neoplasms with a site in China — 334 open to participants now, 359 under way, 30 of them phase 3. Pancreatic Neoplasms · China.

Planned enrollment
56th of 507
320 · median 58
Started
2026
with 56 others
Phase 3
41 of 629
22 open now
Primary completion
2029-01
later than 335 of 358 live
Registered
617th of 629
by date

Among the 629 studies in Pancreatic Neoplasms with a site in China, this one is the 56th largest by planned enrollment of the 507 interventional ones that give a count, is one of 57 that started in 2026, is one of 41 in phase 3, reaches primary completion later than 335 of the 358 other live ones, and was the 617th registered.

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,005 are open to participants now.

Browse Pancreatic Neoplasms studies →

Open to participants now

334 of the 629 studies in Pancreatic Neoplasms with a site in China are open now. Recruiting first, the newest first:

329 more — sign in →

All 334 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 629 studies in Pancreatic Neoplasms with a site in China, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Metastatic Pancreatic Cancer
  • Pancreatic Ductal Adenocarcinoma (PDAC)

Keywords

  • YL201
  • Tambotatug pelitecan
  • Tam-Peli
  • PDAC
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants must voluntarily sign a written 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 performance status (ECOG PS) of 0 or 1.
  4. Participants must have a of at least 3 months.
  5. Participants must have or cytologically confirmed incurable 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 according to v1.1.
  8. Participants must have adequate organ function as defined in the protocol.
  9. Participants must agree to follow the requirements specified in the protocol.

Exclusion criteria

Exclusion Criteria:

  1. Participants with another within 5 years before randomization.
  2. Participants with 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) , history of transplantation, therapy, administration, or or inflammatory diseases.
  8. Participants with uncontrolled or 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, positivity or immunodeficiency, or active virus (HBV) or 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 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.
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
320 participants (estimated)

Study arms

  • Experimental
    Tambotatug pelitecan

    Tambotatug pelitecan, monotherapy

    Drug: Tambotatug pelitecan

  • Active comparator
    Chemotherapy

    Active comparator: nal-IRI+5-FU/LV

    Drug: Liposomal irinotecan · Drug: 5 Fluorouracil · Drug: Leucovorin

Interventions

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

    Also known as: YL201, Tam-Peli

  • 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.

06

What researchers measure

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

  5. TTR

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

    Time frame: 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

    Time frame: Up to approximately 2 years

  7. To evaluate the AUC

    Time frame: Up to approximately 2 years

  8. To evaluate the Cmax

    Time frame: Up to approximately 2 years

  9. To evaluate the Ctrough

    Time frame: Up to approximately 2 years

  10. To evaluate the CL

    Time frame: Up to approximately 2 years

  11. To evaluate the Vd

    Time frame: Up to approximately 2 years

  12. To evaluate the t1/2

    Time frame: Up to approximately 2 years

  13. Immunogenicity

    Incidence of anti-drug antibodies of YL201

    Time frame: Up to approximately 2 years

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jan 2029, 27 months later.

Of 84 phase 3 interventional studies under Pancreatic Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 77. This study's planned 27 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2026
First posted
Sep 4, 2026
StartEst.
Oct 2026
Primary completionEst.
Jan 2029
CompletionEst.
May 2029
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07803783
Responsible party
Sponsor
First posted
Sep 4, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jan 2029 (estimated)
Completion
May 2029 (estimated)
Last update
Sep 4, 2026

Study contacts

MediLink Study Team
Contact
clinicaltrials@medilinkthera.com
+86 512 62858368

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Tambotatug pelitecan

Start the discussion