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A Trial of YL-13027 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Refractory Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE1

A Trial of YL-13027 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Refractory Metastatic Pancreatic Cancer

A Phase 1b Trial of YL-13027 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Refractory Metastatic Pancreatic Cancer

NCT06199466•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

To learn if the study drug, YL-13027, is safe to give in combination with gemcitabine and nab-paclitaxel to participants with pancreatic cancer.

Detailed Description

Primary Objectives 1. To determine the safety and tolerability of YL-13027 in combination with gemcitabine and nab-paclitaxel in participants with refractory metastatic pancreatic cancer. 2. To determine the objective response rate (ORR) of YL-13027 in combination with gemcitabine and nab-paclitaxel in participants with refractory metastatic pancreatic cancer. Secondary Objectives 1. To evaluate other indicators of the antitumor activity of YL-13027 in combination with gemcitabine and nab-paclitaxel. 2. To evaluate the PK of YL-13027 in combination with gemcitabine and nabpaclitaxel. Exploratory Objectives 1. To evaluate the PD effects of YL-13027 in combination with gemcitabine and nabpaclitaxel. 2. To evaluate biomarkers of response and resistance to YL-13027 in combination with gemcitabine and nab-paclitaxel.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years.
•2. Ability to understand and the willingness to sign a written informed consent document. 3. Ability to comply with the study protocol, in the investigator's judgment.
•4\. Participants with histologically confirmed metastatic pancreatic adenocarcinoma.
•6\. Measurable disease with at least one lesion amenable to response assessment per the RECIST v1.1 (Appendix 2).
•7\. Eastern Cooperative Oncology Group performance status of 0 or 1 (Appendix 3).
•8\. Adequate organ and marrow function as defined below :
•Hemoglobin ≥8.0 g/dL o Absolute neutrophil count ≥1500/mm3
•Platelets ≥100,000/mm3
•Total bilirubin ≤1.5 × upper limit of normal (ULN) or direct bilirubin ≤ ULN for participants with total bilirubin levels \>1.5 × ULN
•AST/ALT ≤2.5 × institutional ULN or ≤5 × ULN for patients with liver metastases
+6 more criteria

Exclusion Criteria

•1. Prior therapy with a TGF-β pathway-targeted agent.
•2. Prior treatment with gemcitabine, nab-paclitaxel, or the combination of gemcitabine and nab-paclitaxel.
•3. Unresolved toxicities from prior therapy (defined as having not resolved to NCI CTCAE v.5.0 Grade ≤1 or baseline) or any other toxicity that is deemed irreversible by the investigator. Exceptions include endocrinopathies from prior therapy or disease and successfully treated (such as hypothyroidism, diabetes mellitus), alopecia, vitiligo, and Grade ≤2 peripheral neuropathy.
•4. Known symptomatic brain metastases or primary CNS malignancy. Participants who have stable symptoms and are requiring steroids of 4 mg/day dexamethasone equivalent or less for 2 weeks prior to enrollment are permitted.
•5. Live vaccines within 30 days prior to study treatment initiation.
•6. Human immunodeficiency virus (HIV) infection with a current history of acquired immunodeficiency syndrome-defining illness or HIV infection with CD4+ T cell count \<350 cells/µL and HIV viral load more than 400 copies/µL.
•7. Participants with active viral (any etiology) hepatitis are excluded. However, participants with serologic evidence of chronic hepatitis B virus (HBV) infection (positive hepatitis B surface antigen test and a positive hepatitis B core antibody test) who have a viral load below the limit quantification (HBV DNA titer \<1000 cps/mL or 200 IU/mL) and are not currently on viral suppressive therapy may be eligible and should be discussed with the principal investigators (PIs) and IND Sponsor. The addition of HBV suppressive medication (i.e., entecavir) should be considered during the period of study treatment. Participants with a history of hepatitis C virus infection who have completed curative antiviral treatment and have a viral load below the limit of quantitation may be eligible and should be discussed with the PIs and Investigational New Drug (IND) Sponsor.
•8. Any of the following cardiac criteria experienced currently or within 6 months prior to enrollment: a. Congestive heart failure (New York Heart Association Functional Classification of ≥ Class 2) b. Acute coronary syndrome c. Clinically significant cardiac arrhythmia
•9. Mean QTcF \>470 ms at screening.
•10. Left ventricular ejection fraction \<50% or the lower limit of normal (per institutional standard) at screening.
+7 more criteria

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

January 22, 2024

Primary Completion Date

September 15, 2025

Completion Date

September 15, 2025

Last Updated

December 8, 2025

Enrollment

ACTUAL participants

Conditions

Metastatic Pancreatic Cancer

Interventions

Gemcitabine

DRUG

Nab-paclitaxel

DRUG

YL-13027

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Trial of YL-13027 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Refractory Metastatic Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

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Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

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