NCT06199466

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Given by IV
DRUG	Nab-paclitaxel	Given by IV
DRUG	YL-13027	Given by PO

Timeline

• Start date: 2024-01-22
• Primary completion: 2025-09-15
• Completion: 2025-09-15
• First posted: 2024-01-10
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study