Can a smart drug outsmart pancreatic cancer?
NCT ID NCT07803783
First seen Sep 04, 2026 · Last updated Sep 04, 2026
Summary
This phase III trial tests an experimental drug called YL201 against standard chemotherapy in people with metastatic pancreatic cancer that has progressed after gemcitabine-based treatment. YL201 is designed to deliver a toxin directly to cancer cells that carry a specific marker, B7-H3. The study compares how long the cancer stays under control and how long participants live with YL201 versus the usual care. Around 320 adults will take part, receiving either YL201 every three weeks or standard chemotherapy every two weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tambotatug pelitecan (also called YL201), an experimental antibody-drug conjugate given by intravenous infusion every 3 weeks
- What this could lead to
- If YL201 works, it could offer a new treatment option for people with metastatic pancreatic cancer who have already tried gemcitabine-based chemotherapy, potentially slowing tumor growth and extending life.
- What could go wrong
- This is an early-stage test in a tough-to-treat cancer, so YL201 may not prove better than standard care. Side effects from the drug could also be serious, and results from this trial will need confirmation before the treatment becomes available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 320 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Oct 2026
An estimate. Start dates often move.
- Expected to finish
-
May 2029
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic pancreatic cancer are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a pill duo outsmart a Hard-to-Treat pancreatic cancer mutation?
- AI takes aim at pancreatic cancer: can it forecast chemotherapy outcomes?
- Can a Triple-Drug combo outsmart pancreatic cancer?
- Can removing liver tumors alongside the whipple procedure extend life in stage IV pancreatic cancer?
- A phone call could unlock early cancer detection for High-Risk groups
- Can a One-Two punch of radiation and immunotherapy tame pancreatic cancer?