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

Phase 1

Not yet recruiting

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: YL-13027; Drug: HY-0102; Drug: Gemcitabine; Drug: Nab-paclitaxel

• Registration Number: NCT06662669
• Lead Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.

Brief Summary

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 ...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-27
• Last Update Submitted: 2024-10-27
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29
• Study Start: 2024-11-30
• Primary Completion: 2027-09-30
• Study Completion: 2028-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GroupA (YL-13027+AG )	Nab-paclitaxel	YL-13027: 180mg BID PO Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
GroupA (YL-13027+AG )	YL-13027	YL-13027: 180mg BID PO Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
GroupA (YL-13027+AG )	Gemcitabine	YL-13027: 180mg BID PO Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
Group B (HY-0102+AG )	HY-0102	HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
Group B (HY-0102+AG )	Gemcitabine	HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
Group B (HY-0102+AG )	Nab-paclitaxel	HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
Group C (YL-13027+HY-0102+AG)	YL-13027	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
Group C (YL-13027+HY-0102+AG)	HY-0102	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
Group C (YL-13027+HY-0102+AG)	Gemcitabine	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
Group C (YL-13027+HY-0102+AG)	Nab-paclitaxel	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
Group D (AG)	Gemcitabine	Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
Group D (AG)	Nab-paclitaxel	Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W

Primary Outcome Measures

Name	Time	Method
Objective response rate	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.
Progression-free survival	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

Secondary Outcome Measures

Name	Time	Method
Disease control rate	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.
Adverse events	From time of first dose to 30 days after the last dose.	Incidence of adverse events evaluated by NCI CTCAE v5.0
Plasma concentration of YL-13027 and HY-0102	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.