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

NCT ID: NCT06662669

Last Updated: 2024-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-30

Study Completion Date

2028-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

YL-13027

Intervention Type DRUG

YL-13027 is a small molecule inhibitor of the TGF-βRI target.

Gemcitabine

Intervention Type DRUG

Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.

Nab-paclitaxel

Intervention Type DRUG

Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis

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

Group Type EXPERIMENTAL

HY-0102

Intervention Type DRUG

HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody.

Gemcitabine

Intervention Type DRUG

Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.

Nab-paclitaxel

Intervention Type DRUG

Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis

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

Group Type EXPERIMENTAL

YL-13027

Intervention Type DRUG

YL-13027 is a small molecule inhibitor of the TGF-βRI target.

HY-0102

Intervention Type DRUG

HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody.

Gemcitabine

Intervention Type DRUG

Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.

Nab-paclitaxel

Intervention Type DRUG

Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis

Group D (AG)

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

Group Type ACTIVE_COMPARATOR

Gemcitabine

Intervention Type DRUG

Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.

Nab-paclitaxel

Intervention Type DRUG

Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis

Interventions

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YL-13027

YL-13027 is a small molecule inhibitor of the TGF-βRI target.

Intervention Type DRUG

HY-0102

HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody.

Intervention Type DRUG

Gemcitabine

Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.

Intervention Type DRUG

Nab-paclitaxel

Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis

Intervention Type DRUG

Other Intervention Names

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YL-13027 tablet HY-0102 injection Gemcitabine Hydrochloride for Injection Paclitaxel for Injection (albumin bound)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai YingLi Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Zhingqiang Wang

Role: CONTACT

020-87343571

Other Identifiers

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YL-13027-004

Identifier Type: -

Identifier Source: org_study_id

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