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Metastatic Pancreatic CancerPhase 1/2NCT06662669

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

A Phase 1/2 study testing YL-13027, HY-0102 and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Shanghai YingLi Pharmaceutical Co. Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
YL-13027, HY-0102 and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
30 Nov 2024to 30 Aug 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zhingqiang Wang contact

020-87343571

wangzhq@sysucc.org.cn

About this study

Official title: A Randomized, Open, Parallel-controlled, Multi-center , Phase Ib/Ⅱ Clinical Trial of YL-13027 and/or HY-0102 Combined With AG（Nab-paclitaxel and Gemcitabine) 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.

Being tested
YL-13027, HY-0102, Gemcitabine, Nab-paclitaxel
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YL-13027Drug

    Also called YL-13027 tablet

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

  • HY-0102Drug

    Also called HY-0102 injection

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

  • GemcitabineDrug

    Also called Gemcitabine Hydrochloride for Injection

    Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.

  • Nab-paclitaxelDrug

    Also called Paclitaxel for Injection (albumin bound)

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

Study groups in NCT06662669
Study groupRoleWhat they receive
GroupA (YL-13027+AG )ExperimentalYL-13027: 180mg BID PO Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
Receives: Drug: YL-13027; Drug: Gemcitabine; Drug: Nab-paclitaxel
Group B (HY-0102+AG )ExperimentalHY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
Receives: Drug: HY-0102; Drug: Gemcitabine; Drug: Nab-paclitaxel
Group C (YL-13027+HY-0102+AG)ExperimentalYL-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
Receives: Drug: YL-13027; Drug: HY-0102; Drug: Gemcitabine; Drug: Nab-paclitaxel
Group D (AG)Active comparatorNab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    The proportion of subjects who have a complete response or partial response.

    Measured: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.

  2. Progression-free survival

    Progression-free survival is defined clinically as the time from randomization to disease progression or death from any cause

    Measured: 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)

  1. Disease control rate

    The proportion of subjects who have a complete response, partial response and stable disease.

    Measured: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.

  2. Adverse events

    Incidence of adverse events evaluated by NCI CTCAE v5.0

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

  3. Plasma concentration of YL-13027 and HY-0102

    This composite endpoint will measure the plasma concentration of YL-13027 and HY-0102.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2024
  2. Study start30 Nov 2024 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06662669
Sponsor's protocol ID
YL-13027-004
Status last verified
Oct 2024
First submitted
22 Oct 2024
Last updated
29 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing YL-13027, HY-0102 and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Shanghai YingLi Pharmaceutical Co. Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhingqiang Wang (020-87343571, wangzhq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06662669.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.

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