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

Shanghai Yingli Pharmaceutical

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: Nab-paclitaxel; Drug: HY-0102; Drug: YL-13027; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06662669

YL-13027-004

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

GroupA (YL-13027+AG )

Experimental group

Description:

YL-13027: 180mg BID PO Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W

Treatment:

Drug: Gemcitabine

Drug: YL-13027

Drug: Nab-paclitaxel

Group B (HY-0102+AG )

Experimental group

Description:

HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W

Treatment:

Drug: Gemcitabine

Drug: Nab-paclitaxel

Drug: HY-0102

Group C (YL-13027+HY-0102+AG)

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine

Drug: YL-13027

Drug: Nab-paclitaxel

Drug: HY-0102

Group D (AG)

Active Comparator group

Description:

Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W

Treatment:

Drug: Gemcitabine

Drug: Nab-paclitaxel