Solid TumorPhase 1NCT05228600
YL-13027 in Patients With Advanced Solid Tumors
A Phase 1 study testing YL-13027 in people with Solid Tumor, run by Shanghai YingLi Pharmaceutical Co. Ltd. at 1 site in United States.
Trial summary
Part 1 (Phase Ia): 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. Up to 4 cohorts of 3-6 patients each will be treated in part 1 of the study. One cycle is 28 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- YL-13027
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2022to 1 Dec 2023
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- In order to be eligible for participation in this trial, the patient must meet all the following inclusion criteria:
- Patients with advanced solid tumors that is unresectable or metastatic and considered refractory to or not candidates for all available approved therapy.
- Measurable disease with at least one lesion amenable to response assessment per RECIST 1.1.
- Demonstrate adequate organ function as defined below. All screening laboratories should be performed within 7 days of study treatment initiation.
- System Laboratory Value Hematological Absolute neutrophil count (ANC)
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- 1.5 × 109/L Platelets
- 100 × 109/L Hemoglobin
- 9 g/dL or ≥5.6 mmol/L Renal Creatinine* or
- ≤1.5 × the upper limit of normal (ULN) or Measured or calculated creatinine clearance (CrCl) (Cockroft-Gault)
- 50 mL/min for patient with creatinine levels >1.5 × institutional ULN Hepatic Total bilirubin
- 1.5 × ULN or direct bilirubin ≤ULN for patients with total bilirubin levels > 1.5× ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
- 2.5 × ULN or ≤5 × ULN for patients with liver metastases Cardiac CK-MB, Troponin T, BNP < ULN
- Has a ECOG performance status of 0-1.
- Life expectancy >12 weeks at baseline.
- Women of childbearing potential must have negative serum or urine pregnancy test within 72 hours prior to receiving the first study drug administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- For women of childbearing potential, must be willing to use an adequate method of contraception from 30 days prior to the first study drug administration and at least 3 months following last day study drug administration.
- Male patients of childbearing potential must be surgically sterile, or must agree to use adequate method of contraception during the study and at least 3 months following the last day of study drug administration.
- Age ≥18 years at screening.
- Able and willing to provide written informed consent and to follow study instructions.
- Washout from prior anti-tumor therapy:
- Previous Treatment Length of Time Prior to (Study entry/enrollment/first dose of study treatment) Cytotoxic therapies
- 4 weeks Mitomycin C or nitrosoureas
- 6 weeks Small molecule inhibitors
- 2 weeks or 5x T1/2, whichever is longer Biologic agents (e.g., antibodies)
- 4weeks Immunotherapy (e.g., CTLA4, PD-1, PD-L1 inhibitors)
- 4 weeks Radiotherapy
- 4 weeks Limited field radiotherapy or palliative radiotherapy
- 2 weeks Major surgery, excluding biopsy
- 4 weeks. Patients with recent major surgery must have recovered, in the opinion of the investigator, from the toxicity and/or complication from the intervention before starting therapy
Who cannot join
- The patient will be excluded from participating in the trial if any of the following exclusion criteria are met:
- Prior therapy with a TGF-ß signaling targeted agent.
- Known symptomatic brain metastases requiring steroids above physiologic replacement doses.
- Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
- Live vaccines within 30 days of study treatment.
- Unresolved toxicities from prior therapy, defined as having not resolved to NCI CTCAE v.5.0 Grade ≤1 or baseline, with exception of endocrinopathies from prior therapy and successfully treated (such as hypothyroidism), alopecia, vitiligo, and ≤ grade 2 peripheral neuropathy.
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- Human immunodeficiency virus (HIV) infection with a current or a known history of AIDS-defining illness or HIV infection with a CD4+ T cell count <350 cells/μL and an HIV viral load more than 400 copies/μL.
- Patients with active viral (any etiology) hepatitis are excluded. However, patients with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen test and a positive anti-hepatitis core antigen antibody test) who have a viral load below the limit quantification (HBV DNA titer <1000 cps/mL or 200 IU/mL), and are not currently on viral suppressive therapy may be eligible and should be discussed with the Medical Monitor. Patients with a history of hepatitis C virus (HCV) infection who have completed curative antiviral treatment and have a viral load below the limit of quantitation may be eligible and should be discussed with the Medical Monitor.
- Any of the following cardiac criteria experienced currently or within the last 6 months:
- Congestive heart failure (New York Heart Association ≥ Class 2).
- Any clinically significant abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block or third-degree heart block.
- Acute coronary syndrome within 6 months.
- Clinically significant cardiac arrhythmia.
- Mean QTC interval corrected (Frederica) for heart rate >470 ms.
- Left ventricular ejection fraction (LVEF) <50% or the lower limit of normal (per institutional standard).
- Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection, as determined by the investigator.
- Any condition that impairs a patient's ability to swallow whole pills. Presence of an active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of YL-13027, as determined by the investigator.
- History of interstitial lung disease.
- An active additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Known allergy to any component of YL-13027.
- Participation in another clinical trial of an investigational agent within 30 days of screening.
- Patient has known psychiatric, substance abuse or other disorders that would interfere with cooperation with the requirements of the trial, in the opinion of the investigator.
- Patients who are pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of trial treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Jordi Ahnert Rodon
About this study
Official title: A Multi-Center, Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YL-13027 in Patients With Advanced Solid Tumors
Part 1 (Phase Ia):
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. Up to 4 cohorts of 3-6 patients each will be treated in part 1 of the study. One cycle is 28 days.
Part 2:
This is a dose expansion phase to further evaluate the safety, tolerability and preliminary anti-tumor activity of YL-13027 at the RP2D.
Read the detailed description
3.1.3. Parts 1 and 2: Patients will receive study treatment until criteria for study termination are met.
A Safety Follow-up Visit will be conducted 30 days (±7 days) after the last dose of study treatment Patients who discontinue study treatment for reasons other than disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, patient withdraws consent, is lost to follow-up, death, or until the Sponsor stops the study, whichever comes first.
Adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
Tumor response will be assessed by physical examination, computed tomography (CT) and/or magnetic resonance imaging (MRI) scan using RECIST 1.1 criteria, assessed by the investigator. Patients who discontinue study treatment for reasons other than disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, patient withdraws consent, is lost to follow-up, death, or until the Sponsor stops the study, whichever comes first.
Specific procedures to be performed during the study, as well as their prescribed times and associated visit windows, are outlined in the Schedule of Activities (SoA) see Appendix 1. Details of each procedure are provided in Section 7. The Safety Monitoring Committee (SMC) will monitor safety during the duration of the study. The SMC will make reviews based on Investigator site dose adjustments, adverse events, serious adverse events or discontinuation study treatment and make any appropriate recommendations to the Sponsor.
- Conditions
- Solid Tumor
- Being tested
- YL-13027
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YL-13027Drug
YL-13027 is a novel small molecule TGF-βR1 inhibitor. 1.1.1. Chemical Properties
Chemical Name:
6-(5-fluoro-2-(6-methylpyridin-2-yl)phenyl)imidazo[1,2-a]pyridine-3-carboxamide Molecular Formula C20H15FN4O Molecular Weight 346.36 Formulation YL-13027 is provided as pink film coated tablets for oral administration in two strengths, 30 mg and 120 mg.
Packaging and Storage YL-13027 tablets are packaged (30 tablets/bottle) in the 45 mL opaque HDPE bottles with child resistant polypropylene caps, induction-sealed inner polypropylene liners. YL-13027 tablets should be protected from light in a closed container and stored at room temperature.
Stability The shelf-life of YL-13027 oral tablets is tentatively set at 24 months when stored at room temperature.
| Study group | Role | What they receive |
|---|---|---|
| YL-13027 | Experimental | YL-13027 is a novel small molecule TGF-βR1 inhibitor. 1.1.1. Chemical Properties
Chemical Name:
6-(5-fluoro-2-(6-methylpyridin-2-yl)phenyl)imidazo[1,2-a]pyridine-3-carboxamide Molecular Formula C20H15FN4O Molecular Weight 346.36 Formulation YL-13027 is provided as pink film coated tablets for oral administration in two strengths, 30 mg and 120 mg.
Packaging and Storage YL-13027 tablets are packaged (30 tablets/bottle) in the 45 mL opaque HDPE bottles with child resistant polypropylene caps, induction-sealed inner polypropylene liners. YL-13027 tablets should be protected from light in a closed container and stored at room temperature.
Stability The shelf-life of YL-13027 oral tablets is tentatively set at 24 months when stored at room temperature. Receives: Drug: YL-13027 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency, duration and severity of Adverse Events and Serious Adverse Events
Primary Outcome Measure(s):
Part 1:
Frequency, duration and severity of Adverse Events and Serious Adverse Events.
Part 2:
Frequency, duration and severity of Adverse Events and Serious Adverse Events.
Measured: Throughout the study for approximately 2 years
Secondary outcomes (6)
Pharmacokinetics
Secondary Outcome Measures:
- Pharmacokinetics of YL-13027; to include: AUC, AUClast, AUCinf, AUMC, Cmin, Cmax, CL, T1/2, Tmax, and Vd
Measured: Throughout the study for approximately 2 years
ORR
Efficacy
- Overall Response Rate (ORR).
Measured: Throughout the study for approximately 2 years
DOR
- Efficacy
- Duration of Response (DOR).
Measured: Throughout the study for approximately 2 years
PFS
Efficacy
- Progression Free Survival (PFS).
Measured: Throughout the study for approximately 2 years
Duration of Stable Disease
Efficacy
- Duration of Stable Disease
Measured: Throughout the study for approximately 2 years
Clinical Benefit Rate
Efficacy
- Clinical Benefit Rate (CR+PR+SD)
Measured: Throughout the study for approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start17 May 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yingli Pharma US, Inc
- Responsible party
- Sponsor
- Investigators
- Jordi Ah Rodon, Ph D, Principal investigator, MD Anderson Cancer Center Houston TX 77030Trisha Wi Draper, Ph D, Principal investigator, University of Cincinnati Cincinnati, OH 45267-0562Martin E Gutierrez, MD, Principal investigator, Hackensack University Medical Center Hackensack, NJ 07601Ignacio Ga Laguna,, MD, Ph.D, Principal investigator, Huntsman Cancer Institute Salt Lake City, UT 84112
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228600
- Sponsor's protocol ID
- YL-13027-003
- Status last verified
- Dec 2021
- First submitted
- 20 Dec 2021
- Last updated
- 20 May 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YL-13027 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05228600
- Acronym / sponsor ID
- YL-13027-003
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Yingli Pharma US, Inc
- Study start
- 17 May 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 8 Feb 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.
Part 1 (Phase Ia):
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. Up to 4 cohorts of 3-6 patients each will be treated in part 1 of the study. One cycle is 28 days.
Part 2:
This is a dose expansion phase to further evaluate the safety, tolerability and preliminary anti-tumor activity of YL-13027 at the RP2D.
Detailed description
3.1.3. Parts 1 and 2: Patients will receive study treatment until criteria for study termination are met.
A Safety Follow-up Visit will be conducted 30 days (±7 days) after the last dose of study treatment Patients who discontinue study treatment for reasons other than disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, patient withdraws consent, is lost to follow-up, death, or until the Sponsor stops the study, whichever comes first.
Adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
Tumor response will be assessed by physical examination, computed tomography (CT) and/or magnetic resonance imaging (MRI) scan using RECIST 1.1 criteria, assessed by the investigator. Patients who discontinue study treatment for reasons other than disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, patient withdraws consent, is lost to follow-up, death, or until the Sponsor stops the study, whichever comes first.
Specific procedures to be performed during the study, as well as their prescribed times and associated visit windows, are outlined in the Schedule of Activities (SoA) see Appendix 1. Details of each procedure are provided in Section 7. The Safety Monitoring Committee (SMC) will monitor safety during the duration of the study. The SMC will make reviews based on Investigator site dose adjustments, adverse events, serious adverse events or discontinuation study treatment and make any appropriate recommendations to the Sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YL-13027 | Experimental | Drug: YL-13027YL-13027 is a novel small molecule TGF-βR1 inhibitor. 1.1.1. Chemical Properties Chemical Name: 6-(5-fluoro-2-(6-methylpyridin-2-yl)phenyl)imidazo[1,2-a]pyridine-3-carboxamide Molecular Formula C20H15FN4O Molecular Weight 346.36 Formulation YL-13027 is provided as pink film coated tablets for oral administration in two strengths, 30 mg and 120 mg. Packaging and Storage YL-13027 tablets are packaged (30 tablets/bottle) in the 45 mL opaque HDPE bottles with child resistant polypropylene caps, induction-sealed inner polypropylene liners. YL-13027 tablets should be protected from light in a closed container and stored at room temperature. Stability The shelf-life of YL-13027 oral tablets is tentatively set at 24 months when stored at room temperature. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- -
- In order to be eligible for participation in this trial, the patient must meet all the following inclusion criteria:
- Patients with advanced solid tumors that is unresectable or metastatic and considered refractory to or not candidates for all available approved therapy.
- Measurable disease with at least one lesion amenable to response assessment per RECIST 1.1.
- Demonstrate adequate organ function as defined below. All screening laboratories should be performed within 7 days of study treatment initiation.
Key exclusion criteria (23 listed)
- The patient will be excluded from participating in the trial if any of the following exclusion criteria are met:
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-13027YL-13027 is a novel small molecule TGF-βR1 inhibitor. 1.1.1. Chemical Properties Chemical Name: 6-(5-fluoro-2-(6-methylpyridin-2-yl)phenyl)imidazo[1,2-a]pyridine-3-carboxamide Molecular Formula C20H15FN4O Molecular Weight 346.36 Formulation YL-13027 is provided as pink film coated tablets for oral administration in two strengths, 30 mg and 120 mg. Packaging and Storage YL-13027 tablets are packaged (30 tablets/bottle) in the 45 mL opaque HDPE bottles with child resistant polypropylene caps, induction-sealed inner polypropylene liners. YL-13027 tablets should be protected from light in a closed container and stored at room temperature. Stability The shelf-life of YL-13027 oral tablets is tentatively set at 24 months when stored at room temperature. | Drug | YL-13027 |
Primary outcome
Frequency, duration and severity of Adverse Events and Serious Adverse Events
Time frame: Throughout the study for approximately 2 years
Primary Outcome Measure(s): Part 1: Frequency, duration and severity of Adverse Events and Serious Adverse Events. Part 2: Frequency, duration and severity of Adverse Events and Serious Adverse Events.
6 secondary outcomes
Pharmacokinetics
Time frame: Throughout the study for approximately 2 years
ORR
Time frame: Throughout the study for approximately 2 years
DOR
Time frame: Throughout the study for approximately 2 years
PFS
Time frame: Throughout the study for approximately 2 years
Duration of Stable Disease
Time frame: Throughout the study for approximately 2 years
Clinical Benefit Rate
Time frame: Throughout the study for approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 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.
Jordi Ah Rodon, Ph D principal investigator
MD Anderson Cancer Center Houston TX 77030
Trisha Wi Draper, Ph D principal investigator
University of Cincinnati Cincinnati, OH 45267-0562
Martin E Gutierrez, MD principal investigator
Hackensack University Medical Center Hackensack, NJ 07601
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YL-13027 in people with Solid Tumor, run by Shanghai YingLi Pharmaceutical Co. Ltd. at 1 site in United States.
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 30 inclusion and 23 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 20 May 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 United States. 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 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.
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 Meiyue Hong (13918087228, myhong@yl-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency, duration and severity of Adverse Events and Serious Adverse Events (time frame: Throughout the study for approximately 2 years). 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 20 May 2022.