Chemotherapy

YL-13027 + Chemotherapy for Pancreatic Cancer

Houston, TX

Phase 1

Waitlist Available

Led By Jordi Rodon Ahnert, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group performance status of 0 or 1

Participants with histologically confirmed metastatic pancreatic adenocarcinoma

Must not have

Prior therapy with a TGF-β pathway-targeted agent

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is being conducted to find out if it is safe to give the study drug, YL-13027, along with gemcitabine and nab-paclitaxel to people with

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Who is the study for?

This trial is for individuals with metastatic pancreatic cancer that hasn't responded to previous treatments. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments.Check my eligibility

What is being tested?

The study is testing the safety of a new drug called YL-13027 when given alongside two chemotherapy drugs, Gemcitabine and Nab-paclitaxel, in patients with advanced pancreatic cancer.See study design

What are the potential side effects?

While specific side effects for YL-13027 aren't listed, common side effects from chemotherapy like Gemcitabine and Nab-paclitaxel include nausea, weakness, hair loss, low blood cell counts increasing infection risk, and potential nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have been diagnosed with metastatic pancreatic cancer.

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I am 18 years old or older.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with a TGF-β pathway-targeted agent before.

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I have HIV with a low CD4+ count or high viral load.

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My heart's pumping ability is below normal.

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I have been treated with gemcitabine, nab-paclitaxel, or both.

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I have no lasting side effects from previous treatments.

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I have active hepatitis.

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I haven't taken strong CYP3A affecting drugs in the last 14 days or more.

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I do not have severe or uncontrolled health problems besides my cancer.

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I have brain metastases or a primary brain tumor that causes symptoms.

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I can swallow pills and don't have major GI issues affecting medication absorption.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR) of YL-13027 in combination with gemcitabine and nab-paclitaxel

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment3 Interventions

Participants will receive YL-13027 in combination with gemcitabine and nab-paclitaxel at the recommended dose that was found in the Dose Escalation part.

Group II: Dose EscalationExperimental Treatment3 Interventions

Participants will be assigned to a dose level of YL-13027 in combination with gemcitabine and nab-paclitaxel based on when you join this study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nab-paclitaxel

2014

Completed Phase 3

~2490

Gemcitabine

2017