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

NCT06662669 | Not Yet Recruiting Phase 1

• 1 other identifier: YL-13027-004
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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.

• Adverse events

  From time of first dose to 30 days after the last dose.

• Plasma concentration of YL-13027 and HY-0102

  From one hour before the first dose to the last dose up to 24months.

Study Arms (4)

GroupA (YL-13027+AG )

EXPERIMENTAL

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; Drug: Gemcitabine; Drug: Nab-paclitaxel

Group B (HY-0102+AG )

EXPERIMENTAL

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; Drug: Gemcitabine; Drug: Nab-paclitaxel

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

EXPERIMENTAL

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; Drug: HY-0102; Drug: Gemcitabine; Drug: Nab-paclitaxel

Group D (AG)

ACTIVE COMPARATOR

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

Drug: Gemcitabine; Drug: Nab-paclitaxel

Interventions

YL-13027 DRUG

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

Also known as: YL-13027 tablet

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

HY-0102 DRUG

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

Also known as: HY-0102 injection

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

Gemcitabine DRUG

Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.

Also known as: Gemcitabine Hydrochloride for Injection

Group B (HY-0102+AG ); Group C (YL-13027+HY-0102+AG); Group D (AG); GroupA (YL-13027+AG )

Nab-paclitaxel DRUG

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

Also known as: Paclitaxel for Injection (albumin bound)

Group B (HY-0102+AG ); Group C (YL-13027+HY-0102+AG); Group D (AG); GroupA (YL-13027+AG )

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai YingLi Pharmaceutical Co. Ltd.: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Injections; 130-nm albumin-bound paclitaxel; Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Administration Routes; Drug Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Zhingqiang Wang

CONTACT

020-87343571; wangzhq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 29, 2024
• Study Start: November 30, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): August 30, 2028
• Last Updated: October 29, 2024

Record last verified: 2024-10