NCT06662669Not yet recruitingPhase 1/2
YL-13027 and/or HY-0102 Combined With AG Regimen Chemotherapy for Metastatic Pancreatic Cancer
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
Source: ClinicalTrials.gov · Last updated 29 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 22 Oct 2024
- Start date
- 30 Nov 2024
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.
- Diseases
- Pancreatic cancer
- NCT number
- NCT06662669
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 120
- From 30 Nov 2024 to the primary completion date, 30 Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject suitable for potentially curative surgery.
- The subject has previously received gemcitabine and nab-paclitaxel combination therapy within 6 months of progression or intolerance.
Other
- The subject confirmed by tissue or cytology as other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, etc.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.