YL-13027 And/or HY-0102 Combined With AG Regimen Chemotherapy For Metastatic Pancreatic Cancer

Study Overview

YL-13027 and/or HY-0102 Combined With AG 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.

N/A

Metastatic Pancreatic Cancer

DRUG: YL-13027
DRUG: HY-0102
DRUG: Gemcitabine
DRUG: Nab-paclitaxel

YL-13027-004

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-10-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-10-27
First Submitted that Met QC Criteria 2024-10-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-10-29
First Posted (ACTUAL) 2024-10-29	Results First Posted N/A	Last Verified 2024-10

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

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. DRUG: Gemcitabine Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent. DRUG: Nab-paclitaxel Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis
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: HY-0102 HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody. DRUG: Gemcitabine Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent. DRUG: Nab-paclitaxel Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis
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. DRUG: HY-0102 HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody. DRUG: Gemcitabine Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent. DRUG: Nab-paclitaxel Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis
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. DRUG: Nab-paclitaxel Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis

Primary Outcome Measures	Measure Description	Time Frame
Objective response rate	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	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	Measure Description	Time Frame
Disease control rate	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	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	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.

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

Name: Zhingqiang Wang

Phone Number: 020-87343571

Email: wangzhq@sysucc.org.cn

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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