A Phase I Study of YY-20394 in Patients With Advanced Solid Tumors

August 7, 2019 updated by: Shanghai YingLi Pharmaceutical Co. Ltd.

A Single-Arm, Open-Label, Multi-Center, Phase I Study of YY-20394 in Patients With Advanced Solid Tumors

Protocol YY-20394-003 is a phase I single arm, open label study. The primary objective is to assess the safety of YY-20394 in subjects with advanced solid tumor. The secondary objective is to determine the preliminary efficacy and pharmacokinetics (PK).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this clinical trials, patients will be dosed YY-20394 orally at 80mg per day until disease progression, unacceptable toxicity, or withdrawal from the study. A treatment cycle is defined as 28 days. Drug safety will be evaluated by NCI-CTC AE5.0 every week within 28 days after first dose and every 2 weeks in the following cycles. Efficacy will be assessed by RECIST1.1 after 2 cycles.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200123
        • Shanghai East Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and/or females over age 18
  2. Histologically or cytologically confirmed advanced solid tumors. Failure or lack of standard treatment.
  3. Eastern Cooperative Oncology Group performance status of 0 to 2
  4. Life expectancy of at least 3 months
  5. At least one measurable lesion according to RECIST1.1.

  6. Acceptable hematologic status:

    Absolute neutrophil count(ANC)≥1.5×10^9/L; Platelet count(PLT)≥75×10^9/L; Hemoglobin(Hb)≥80 g/L; Total bilirubin(TBIL)≤1.5×Upper limit of normal value(ULN); Alanine aminotransferase(ALT)≤1.5×ULN; Aspartate aminotransferase(AST)≤1.5×ULN; Creatinine(Cr)≤1.5×ULN; Left Ventricular Ejection Fractions(LVEF)≥50%； QTcF：male<450 ms,female<470 ms

  7. Accept to use proper contraceptives throughout the study period and within 6 months after the last dose.
  8. Ability to respect the protocol approved by investigator.
  9. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Previously treated with PI3Kδ inhibitors and cause disease progression (removed from the study because of intolerance is not included).
  2. Any anti-tumor treatment, within 4 weeks prior to study entry, such as chemotherapy, radiotherapy and immunotherapy. Nitrosoureas or mitomycin C within 6 weeks prior to study entry. Oral drug of fluorouracil or small molecular targeted drugs 2 weeks prior to study entry.
  3. Any other investigational agents within 4 weeks prior to study entry.
  4. Any surgery on main organ (needle biopsy not included) or serious injury within 4 weeks prior to study entry. Selective operation is required during the study period.
  5. Adverse events of previous anti-cancer treatment have not recovered to CTCAE v5.0 ≤1.
  6. There are third interstitial effusions (such as massive pleural effusion and ascites) which can not be controlled by drainage or other methods.
  7. The dosage of steroid hormone (prednisone equivalent) was greater than 20mg/day, and lasted for more than 14 days.
  8. Medical history of difficulty in swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested drug.
  9. During the study period, drugs that may prolong the QT (such as anti arrhythmic drugs) could not be interrupted.
  10. Patients with central nervous system (CNS) matastasis or meningeal metastasis with clinical symptoms, or there are evidences of CNS matastasis or meningeal metastasis uncontrolled approved by investigators.
  11. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy(such as pneumonia).
  12. Active hepatitis b (HBV titers>1000 copies/ml or 200IU/ml), prophylactic antiviral therapies other than interferon are allowed. Patients with Hepatitis C virus (hepatitis C antibody test positive).
  13. History of immunodeficiency, including HIV positive test, other acquired or congenital immunodeficiency disorders, organ transplantation or allogeneic bone marrow transplantation.
  14. Has suffered from any heart disease within 6 months prior to study entry, including: (1) angina pectoris; (2) medicated or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) any other heart disease judged by the researchers not suitable for the test.
  15. The baseline pregnancy test was positive in pregnant women, lactating women or fertile women.
  16. According to the judgement of the investigator, 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.
  17. Patients suffering from other primary malignant tumors in the past 5 years. Patients with curable local tumors (such as basal or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix or of the breast) could be enrolled after completely cured.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: YY-20394
YY-20394 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons.
Drug: YY-20394
YY-20394 is a new type of PI3K-δ selective inhibitor which differs structurally from idelalisib and its analogs, showing high potency against PI3Kδ, but with markedly improved selectivity (>1,000-fold selectivity for PI3K-δ versus PI3Kγ). This higher selectivity for PI3Kδ may decrease the risk of serious infection seen with idelalisib and especially with duvelisib due to strong immune suppression.Preclinical evaluation has demonstrated improved efficacy and safety for YY-20394 compared to idelalisib.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse events evaluated by NCI CTCAE v5.0
Time Frame: with in 2 years after the first dose
Incidence of adverse events of YY-20394
with in 2 years after the first dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: with in 56 days after the first dose
Response will be determined by Response evaluation criteria in solid tumours; v1.1
with in 56 days after the first dose
Disease control rate
Time Frame: with in 56 days after the first dose
DCR will be determined by Response evaluation criteria in solid tumours v1.1
with in 56 days after the first dose
Maximum concentration (Cmax)
Time Frame: 10 mins pre-dose in D1, D7, D14; 0.5, 1, 2, 4, 6, 8, 24 hours after the first dose
One of Pharmacokinetic (PK) parameters.
10 mins pre-dose in D1, D7, D14; 0.5, 1, 2, 4, 6, 8, 24 hours after the first dose
Time to maximum concentration (Tmax)
Time Frame: 10 mins pre-dose in D1, D7, D14; 0.5, 1, 2, 4, 6, 8, 24 hours after the first dose
One of Pharmacokinetic (PK) parameters.
10 mins pre-dose in D1, D7, D14; 0.5, 1, 2, 4, 6, 8, 24 hours after the first dose
Minimum concentration(Cmin)
Time Frame: 10 mins pre-dose in D1, D7, D14; 0.5, 1, 2, 4, 6, 8, 24 hours after the first dose
One of Pharmacokinetic (PK) parameters.
10 mins pre-dose in D1, D7, D14; 0.5, 1, 2, 4, 6, 8, 24 hours after the first dose
Area under the curve (AUC)
Time Frame: 10 mins pre-dose in D1, D7, D14; 0.5, 1, 2, 4, 6, 8, 24 hours after the first dose
One of Pharmacokinetic (PK) parameters.
10 mins pre-dose in D1, D7, D14; 0.5, 1, 2, 4, 6, 8, 24 hours after the first dose
Half-life (t1/2)
Time Frame: 10 mins pre-dose in D1, D7, D14; 0.5, 1, 2, 4, 6, 8, 24 hours after the first dose
One of Pharmacokinetic (PK) parameters.
10 mins pre-dose in D1, D7, D14; 0.5, 1, 2, 4, 6, 8, 24 hours after the first dose
Clearance (CL)
Time Frame: 10 mins pre-dose in D1, D7, D14; 0.5, 1, 2, 4, 6, 8, 24 hours after the first dose
One of Pharmacokinetic (PK) parameters.
10 mins pre-dose in D1, D7, D14; 0.5, 1, 2, 4, 6, 8, 24 hours after the first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai YingLi Pharmaceutical Co. Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YY-20394-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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