Advanced Solid TumorsPhase 1/2NCT05457517
A Phase 1b/2 Study of YL-13027 Combined With Sintilimab in Patients With Advanced Solid Tumors
A Phase 1/2 study testing YL-13027，Sintilimab in people with Advanced Solid Tumors, run by Shanghai YingLi Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
This study is a one-arm, open, multicenter phase 1b/2 clinical trial of YL-13027 combined with Sintilimab in patients with Advanced Solid Tumors, aiming at exploring the MTD and RP2D and observing the preliminary efficacy.The trial can be divided into two parts: dose escalation part and expansion part.Sintilimab is… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- YL-13027，Sintilimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2022to 1 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Males and/or females age from 18 to 75.
- Histologically or cytologically confirmed patients with advanced malignant solid tumors, extracranial solid tumors must be malignant tumors, including but not limited to lung cancer, head and neck cancer, renal clear cell carcinoma, urinary epithelial carcinoma, chordoma, etc. Intracranial primary tumors include malignant tumors and some benign tumors lacking effective standard treatment after current recurrence, including but not limited to glioma, meningioma, ependymoma, craniopharyngioma, refractory pituitary tumor, etc. Eligible patients must have failed standard treatment, have no standard treatment, have refused standard treatment, or have been determined by the investigator to be unsuitable for standard treatment at this stage.
- At least 1 measurable lesion according to tumor assessment criteria.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Life expectancy of at least 3 months.
- Acceptable organ function: Absolute neutrophil count(ANC)≥1.5×109/L, Platelet count(PLT)≥100×109/L, Hemoglobin(Hb)≥90 g/L, Total bilirubin(TBIL)≤1.5×Upper limit of normal value(ULN), Alanine aminotransferase(ALT)≤2.5×ULN, Aspartate aminotransferase(AST)≤2.5×ULN, Creatinine(Cr)≤1.5×ULN, Creatinine clearance ≥50ml/min, Left Ventricular Ejection Fractions(LVEF)≥50%, QTcF<450 ms.
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- The washout period from the last time accepting any anti-tumor treatment (including chemotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, tumor embolization) to participating in this test should be 3 weeks or more.The washout period of oral fluorouracil should be 2 weeks or more, and that of mitomycin and nitrosocarbamide should be 6 weeks or more.The washout period of drugs with anti-tumor angiogenic effects (those targeting VEGF, VEGF receptors including, but not limited to bevacizumab, anlotinib, apatinib, furquinib, lenvatinib, sorafenib, regorafenib, etc.) should be 8 weeks or more. The washout period of other anti-tumor treatments (radiotherapy, treatment with other test drugs) should be 4 weeks or more.
- Fertile male and female must agree to use medically approved contraceptives during the study and within 6 months after the last dose of the study.
- Blood pregnancy test of female who is capable of conceivingshould be negative 7 days before the first dose.Patients cannot breastfeed.If the patient has stopped breastfeeding at the time of study entry, the cessation of breastfeeding must be from the day of first dose to more than 30 days after the last dose.
- The last time participate in an investigational drug study should be more than one month prior to the study entry.
- According to the judgment of the investigator, the patient has high compliance and is willing to complete the experiment and comply with the protocol.
- Voluntary participation in this clinical trial, understanding of the study procedures and the ability to sign informed consent forms (ICFs).
Who cannot join
- There is third interstitial effusion (such as massive pleural effusion and ascites) which can not be controlled by drainage or other methods.
- Within 3 months before the first dose, grade 3 or grade 4 gastrointestinal bleeding or varicose bleeding and requiring blood transfusion or endoscopic or surgical intervention has happened.
- Medical history of difficulty in swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
- Patients with a definitely history of neurological or psychiatric disorders.
- Known infection with human immunodeficiency virus (HIV), hepatitis B virus(HBV), or hepatitis C virus (HCV).
- History of immunodeficiency, including HIV positive test, other acquired or congenital immunodeficiency disorders, organ transplantation or allogeneic bone marrow transplantation.
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- Exists moderate or severe heart disease: (1) Within 6 months before the first dose,myocardial infarction, angina, grade II/III/IV congestive heart failure, pericardial effusion, uncontrollable severe hypertension (up to 150/90 mmHg or more) . (2) ECG abnormalities with clinical significance: symptomatic or persistent atrial or ventricular arrhythmias, degree II or III atrioventricular block, bundle branch block. (3) The echocardiogram shows significant abnormalities: For example, moderate or severe heart valve function defects are assessed according to the normal lower limit of the institution;Patients with minor or mild valve regurgitation (tricuspid, pulmonary, mitral, or aortic) can be included in this study. (4) Laboratory examination shows troponin T levels increasing. (5) Various factors that may increase the risk of QTcF prolonging or arrhythmia events. (6) Predisposition factors cause the development of ascending aorta or aortic arch aneurysm: For example, marfan syndrome, CT records of the history of cardiac vascular injury. (7) History of heart or aortic surgery.
- Intracerebral lesions with significant space occupying effects (needing Dehydration treatment, glucocorticoid treatment or diuretic treatment)，spinal cord or pia mater dissemination.
- At the beginning of the study, the unrecovered toxicity of the previous treatment exceeded CTCAE5.0 grade 1(except for hair loss).
- According to the judgement of the researcher,there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study (such as severe hypertension, diabetes, thyroid diseases, etc.).
- Patients has received vaccines other than inactivated vaccine within 30 days before enrollment.
- The investigator considers that the patient has other reasons for not being suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
ruofan huang, phD, ruofanhuang@fudan.edu.cn
About this study
Official title: A Multi-Center, Open-Label, Phase Ib/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YL-13027 Combined With Sintilimab in Patients With Advanced Solid Tumors
This study is a one-arm, open, multicenter phase 1b/2 clinical trial of YL-13027 combined with Sintilimab in patients with Advanced Solid Tumors, aiming at exploring the MTD and RP2D and observing the preliminary efficacy.The trial can be divided into two parts: dose escalation part and expansion part.Sintilimab is administered as a fixed-dose intravenous injection(200mgQ3w）.
Read the detailed description
Part 1 (Phase Ib):
This is a dose escalation,3+3 design study, to evaluate the safety and tolerability, and to determine the RP2D of YL-13027 when administered b.i.d. in patients with advanced solid tumors. One cycle is 21 days.
Part 2 (Phase II):
This is an expansion phase in patients with advantage advanced solid tumors to further evaluate the safety, tolerability and preliminary anti-tumor activity of YL-13027 at the RP2D combined with Sintilimab.
- Conditions
- Advanced Solid Tumors
- Being tested
- YL-13027，Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YL-13027，SintilimabDrug
Also called YL-13027 tablet，Sintilimab injection
YL-13027 combined with Sintilimab will be used as a cycle for 21 days. YLl-13027 is administered orally twice a day. Starting dose of YL-13027 is 240mg/d，with escalation to 360mg/d in phase Ib, and RP2D was administered orally twice a day in phase II.
Sindilizumab is administered intravenously 200mg every three weeks
| Study group | Role | What they receive |
|---|---|---|
| YL-13027+Sintilimab | Experimental | YL-13027 tablets will be given daily for 21 days in 21-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the patient discontinues from the study treatment for other reasons.
Sindilizumab injection will be given 200mg every three weeks. Receives: Drug: YL-13027，Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Adverse events evaluated by NCI CTCAE v5.0
Measured: from the first dose to within 30 days after the last dose.
Secondary outcomes (7)
Maximum concentration (Cmax)
One of Pharmacokinetic (PK) parameters.
Measured: within 42 days after the first dose
Time to maximum concentration (Tmax)
One of Pharmacokinetic (PK) parameters.
Measured: within 42 days after the first dose
Area under the curve (AUC)
One of Pharmacokinetic (PK) parameters.
Measured: within 42 days after the first dose
Half-life (t1/2)
One of Pharmacokinetic (PK) parameters.
Measured: within 42 days after the first dose
Clearance (CL)
One of Pharmacokinetic (PK) parameters.
Measured: within 42 days after the first dose
Objective response rate
the proportion of patients 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.
Disease control rate
the proportion of patients who have a Complete Response, Partial Response or 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start24 Sep 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- YL-13027 combined with Sintilimab was used as a cycle for 21 days.
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanying Bao, PhD, Study director, Shanghai YingLi Pharmaceutical Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457517
- Sponsor's protocol ID
- YL-13027-002
- Status last verified
- Sep 2022
- First submitted
- 27 Jun 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Phase Ib/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YL-13027 Combined With Sintilimab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05457517
- Acronym / sponsor ID
- YL-13027-002
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a one-arm, open, multicenter phase 1b/2 clinical trial of YL-13027 combined with Sintilimab in patients with Advanced Solid Tumors, aiming at exploring the MTD and RP2D and observing the preliminary efficacy.The trial can be divided into two parts: dose escalation part and expansion part.Sintilimab is administered as a fixed-dose intravenous injection(200mgQ3w）.
Detailed description
Part 1 (Phase Ib):
This is a dose escalation,3+3 design study, to evaluate the safety and tolerability, and to determine the RP2D of YL-13027 when administered b.i.d. in patients with advanced solid tumors. One cycle is 21 days.
Part 2 (Phase II):
This is an expansion phase in patients with advantage advanced solid tumors to further evaluate the safety, tolerability and preliminary anti-tumor activity of YL-13027 at the RP2D combined with Sintilimab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- YL-13027 combined with Sintilimab was used as a cycle for 21 days.
| Arm | Type | Receives |
|---|---|---|
| YL-13027+Sintilimab | Experimental | Drug: YL-13027，SintilimabYL-13027 tablets will be given daily for 21 days in 21-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the patient discontinues from the study treatment for other reasons. Sindilizumab injection will be given 200mg every three weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males and/or females age from 18 to 75.
- Histologically or cytologically confirmed patients with advanced malignant solid tumors, extracranial solid tumors must be malignant tumors, including but not limited to lung cancer, head and neck cancer, renal clear cell carcinoma, urinary epithelial carcinoma, chordoma, etc. Intracranial primary tumors include malignant tumors and some benign tumors lacking effective standard treatment after current recurrence, including but not limited to glioma, meningioma, ependymoma, craniopharyngioma, refractory pituitary tumor, etc. Eligible patients must have failed standard treatment, have no standard treatment, have refused standard treatment, or have been determined by the investigator to be unsuitable for standard treatment at this stage.
- At least 1 measurable lesion according to tumor assessment criteria.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Life expectancy of at least 3 months.
Key exclusion criteria (12 listed)
- There is third interstitial effusion (such as massive pleural effusion and ascites) which can not be controlled by drainage or other methods.
- Within 3 months before the first dose, grade 3 or grade 4 gastrointestinal bleeding or varicose bleeding and requiring blood transfusion or endoscopic or surgical intervention has happened.
- Medical history of difficulty in swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
- Patients with a definitely history of neurological or psychiatric disorders.
- Known infection with human immunodeficiency virus (HIV), hepatitis B virus(HBV), or hepatitis C virus (HCV).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YL-13027，SintilimabAlso: YL-13027 tablet，Sintilimab injectionYL-13027 combined with Sintilimab will be used as a cycle for 21 days. YLl-13027 is administered orally twice a day. Starting dose of YL-13027 is 240mg/d，with escalation to 360mg/d in phase Ib, and RP2D was administered orally twice a day in phase II. Sindilizumab is administered intravenously 200mg every three weeks | Drug | YL-13027+Sintilimab |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: from the first dose to within 30 days after the last dose.
Adverse events evaluated by NCI CTCAE v5.0
7 secondary outcomes
Maximum concentration (Cmax)
Time frame: within 42 days after the first dose
Time to maximum concentration (Tmax)
Time frame: within 42 days after the first dose
Area under the curve (AUC)
Time frame: within 42 days after the first dose
Half-life (t1/2)
Time frame: within 42 days after the first dose
Clearance (CL)
Time frame: within 42 days after the first dose
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.
Disease control 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanying Bao, PhD study director
Shanghai YingLi Pharmaceutical Co. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing YL-13027，Sintilimab in people with Advanced Solid Tumors, run by Shanghai YingLi Pharmaceutical Co. Ltd. at 1 site in China.
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 12 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanying Bao, PhD (86 21-51370693, hybao@yl-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: from the first dose to within 30 days after the last dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2022.