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

NCT07803783 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: TAISHAN-305
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma (PDAC)

Keywords

YL201; Tambotatug pelitecan; Tam-Peli; PDAC

Outcome Measures

Primary Outcomes (2)

• 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

  Up to approximately 2 years

• OS

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

  Up to approximately 2 years

Secondary Outcomes (13)

• PFS by investigator

  Up to approximately 2 year

• ORR

  Up to approximately 2 years

• DCR

  Up to approximately 2 years

• DoR

  Up to approximately 2 years

• TTR

  Up to approximately 2 years

Study Arms (2)

Tambotatug pelitecan

EXPERIMENTAL

Tambotatug pelitecan, monotherapy

Drug: Tambotatug pelitecan

Chemotherapy

ACTIVE COMPARATOR

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

Drug: Liposomal irinotecan; Drug: 5 Fluorouracil; Drug: Leucovorin

Interventions

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.

Also known as: YL201, Tam-Peli

Tambotatug pelitecan

5 Fluorouracil DRUG

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

Chemotherapy

Liposomal irinotecan DRUG

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

Chemotherapy

Leucovorin DRUG

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

Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• MediLink Therapeutics (Suzhou) Co., Ltd.: lead

Study Sites (1)

Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

irinotecan sucrosofate; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Central Study Contacts

MediLink Study Team

CONTACT

+86 512 62858368; clinicaltrials@medilinkthera.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: September 4, 2026

Record last verified: 2026-09

Locations

CN (1)