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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

50

Phase

  • 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 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

Ages Eligible for Study

16 years to 83 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
Intervention / Treatment
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

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

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

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)

August 1, 2019

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

July 21, 2019

First Submitted That Met QC Criteria

August 7, 2019

First Posted (Actual)

August 8, 2019

Study Record Updates

Last Update Posted (Actual)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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