YL-13027 and/or HY-0102 Combined With AG Regimen Chemotherapy for Metastatic Pancreatic Cancer

October 27, 2024 updated by: Shanghai YingLi Pharmaceutical Co. Ltd.

A Randomized, Open, Parallel-controlled, Multi-center , Phase Ib/Ⅱ Clinical Trial of YL-13027 and/or HY-0102 Combined With AG（Nab-paclitaxel and Gemcitabine) Regimen Chemotherapy for Metastatic Pancreatic Cancer

In Phase 1b study, six subjects will be enrolled in Arm A (YL-13027 + AG regimen) and Arm B (HY-0102 + AG regimen). The first 12 subjects will be evaluated for safety after one cycle. After safety assessment, subjects will start to enroll in Arm C (YL-13027 + HY-0102 + AG regimen). Each group is planned to include 12-20 subjects. According to the safety and efficacy results of 3 arms of subjects in phase Ib, 1-2 groups were selected for expansion, and a randomized controlled study will be conducted with the standard treatment AG （Arm 4）regimen chemotherapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject aged between 18 and 75 years.
  • Subject has histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
  • Subject has at least one evaluable metastatic lesion according to RECIST 1.1 criteria;
  • Subject has an ECOG score of 0-1 and is expected to survive more than 3 months;
  • Subjects have a good level of organ function.

Exclusion Criteria:

  • Subject suitable for potentially curative surgery.
  • The subject confirmed by tissue or cytology as other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, etc.
  • The subject has previously received gemcitabine and nab-paclitaxel combination therapy within 6 months of progression or intolerance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GroupA (YL-13027+AG )
YL-13027: 180mg BID PO Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
Drug: YL-13027
YL-13027 is a small molecule inhibitor of the TGF-βRI target.
Other Names:
  • YL-13027 tablet
Drug: Gemcitabine
Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.
Other Names:
  • Gemcitabine Hydrochloride for Injection
Drug: Nab-paclitaxel
Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis
Other Names:
  • Paclitaxel for Injection (albumin bound)
Experimental: Group B (HY-0102+AG )
HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
Drug: Gemcitabine
Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.
Other Names:
  • Gemcitabine Hydrochloride for Injection
Drug: Nab-paclitaxel
Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis
Other Names:
  • Paclitaxel for Injection (albumin bound)
Drug: HY-0102
HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody.
Other Names:
  • HY-0102 injection
Experimental: Group C (YL-13027+HY-0102+AG)
YL-13027: 180mg BID PO HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
Drug: YL-13027
YL-13027 is a small molecule inhibitor of the TGF-βRI target.
Other Names:
  • YL-13027 tablet
Drug: Gemcitabine
Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.
Other Names:
  • Gemcitabine Hydrochloride for Injection
Drug: Nab-paclitaxel
Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis
Other Names:
  • Paclitaxel for Injection (albumin bound)
Drug: HY-0102
HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody.
Other Names:
  • HY-0102 injection
Active Comparator: Group D (AG)
Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
Drug: Gemcitabine
Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.
Other Names:
  • Gemcitabine Hydrochloride for Injection
Drug: Nab-paclitaxel
Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis
Other Names:
  • Paclitaxel for Injection (albumin bound)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
The proportion of subjects who have a complete response or partial response.
From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
Progression-free survival
Time Frame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
Progression-free survival is defined clinically as the time from randomization to disease progression or death from any cause
From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate
Time Frame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
The proportion of subjects who have a complete response, partial response and stable disease.
From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
Adverse events
Time Frame: From time of first dose to 30 days after the last dose.
Incidence of adverse events evaluated by NCI CTCAE v5.0
From time of first dose to 30 days after the last dose.
Plasma concentration of YL-13027 and HY-0102
Time Frame: From one hour before the first dose to the last dose up to 24months.
This composite endpoint will measure the plasma concentration of YL-13027 and HY-0102.
From one hour before the first dose to the last dose up to 24months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai YingLi Pharmaceutical Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

August 30, 2028

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 27, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 27, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YL-13027-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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