A Study to Evaluate the Combination of YH003, YH001 and Pembrolizumab in Subjects With Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05176509|
Recruitment Status : Recruiting
First Posted : January 4, 2022
Last Update Posted : October 12, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: YH003 Drug: YH001 Drug: Pembrolizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the Combination of YH003, YH001 and Pembrolizumab in Subjects With Advanced Solid Tumors|
|Actual Study Start Date :||April 5, 2022|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||December 2024|
YH003 will be administered intravenously over 60 minutes every 21-day cycle.
YH001 will be administered intravenously over 60 minutes every 21-day cycle.
Pembrolizumab will be administered intravenously over 30 minutes every 21-day cycle.
- Adverse events (AEs) [ Time Frame: up to 1 year after the last dosing ]The safety will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0
- Maximum tolerated dose (MTD) and/or Recommended phase 2 dose (RP2D) [ Time Frame: up to 1 year after the last dosing ]The MTD and/or RP2D will be determined based on the data of safety and tolerability
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 1. Subjects must have the ability to understand and willingness to sign a written informed consent document.
- 2. Subjects must have histologically advanced or cytologically confirmed solid tumor.
- 3. Subjects have progressed on after treatment with at least one standard therapy, or intolerant of the standard therapy, or no standard therapy accessible to the patients due to any reason
- 4. Subject must have at least 1 unidimensional measurable disease by RECIST 1.1(Eisenhauer et al., 2009).
- 5. Subjects must be age 18 years or older.
- 6. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 7. Life expectancy ≥3 months based on investigator's judgement.
- 8. Subjects must meet the following laboratory values at the screening
- 9. Women of reproductive potential must have negative serum beta human chorionic gonadotropin (β -HCG) pregnancy test within 7 days of the first dose of study drugs.
- 10. Women of reproductive potential who are sexually active with a non-sterilized male must consistently use highly effective contraception/birth control between signing of the informed consent and 120 days after the last administration of the study drugs.
- 1. Subjects have another active invasive malignancy within 5 years
- 2. Subjects must not have received any anticancer therapy or another investigational agent within the longer of 4 weeks or 5 half-lives before the first dose of the study treatment
- 3. Subjects with a history of ≥ Grade 3 immune-related adverse events resulted from previous immunotherapy.
- 4. History of clinically significant sensitivity or allergy to monoclonal antibodies and their excipients or known allergies to antibodies produced from Chinese hamster ovary cells, which in the opinion of the Investigator suggests an increased potential for an adverse hypersensitivity to YH003, YH001 or Pembrolizumab.
- 5. Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.
- 6. History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis, or history of interstitial lung disease.
- 7. Subjects must not have a known or suspected history of an autoimmune disorder
- 8. Clinically uncontrolled intercurrent illness, including active coagulopathy, uncontrolled diabetes, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies.
- 9. Has an active infection requiring systemic therapy.
- 10. Severe cardiovascular disease including symptomatic congestive heart failure (New York Heart Association class III or IV), unstable angina, uncontrolled hypertension, active coagulopathy, uncontrolled diabetes (blood glucose > 250 mg/dl), uncontrolled peritoneal effusion, cardiac arrhythmia, a history of myocardial infarction within 6 months or a history of arterial thromboembolic event and pulmonary embolism within 3 months of the first dose of investigational agent.
- 11. QTcF> 480 ms at baseline; no concomitant medications that would prolong the QT interval; no family history of long QT syndrome.
- 12. Subjects must not have active infection of human immunodeficiency virus (HIV), hepatitis B, hepatitis C or Covid-19.
- 13. Subjects must not have a history of primary immunodeficiency.
- 14. Subjects from endemic area will be specifically screened for tuberculosis. Subjects with active tuberculosis are excluded. Subjects who have received BCG vaccination may have a false positive PPD test. These subjects are eligible if they have a negative Interferon Gamma Release Assay (IGRA).
- 15. Subjects must not receive concurrent or prior use of an immunosuppressive agent within 4 weeks of the first dose
- 16. Major surgery within 4 weeks prior to study entry and Minor surgery within 2 weeks prior to the first dose.
- 17. Subjects must not have received any vaccine within 28 days before the first dose, and subjects, if enrolled, should not receive live vaccines during the study or for 180 days after the last dose.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05176509
|Contact: Fangxia Pan||86 010 firstname.lastname@example.org|
|Australia, New South Wales|
|Blacktown Cancer and Haematology Centre, Clinical Trials, Block C, Level 3, 18 Blacktown Road||Recruiting|
|Blacktown, New South Wales, Australia, 2148|
|Contact: Amanda Bryant 2867 05069 Amanda.Bryant1@Health.nsw.gov.au|
|"Oncology Clinical Trial Unit St George Private Hospital 1 South Street"||Recruiting|
|Kogarah, New South Wales, Australia, 2217|
|Contact: Tracy Liaw 2 8594 5785 LiawT@ramsayhealth.com.au|
|55 Commercial Rd, Level 2 WBRC||Recruiting|
|Melbourne, Victoria, Australia|
|Contact: Nikki Cross 390763534 N.Cross@alfred.org.au|
|Level 3, Suite 7, North Building, Frankston Private, 5 Susono Way, Frankston||Recruiting|
|Prahran, Victoria, Australia|
|Contact: Albert Goikhman 3 9113 1307 email@example.com|
|Responsible Party:||Eucure (Beijing) Biopharma Co., Ltd|
|Other Study ID Numbers:||
|First Posted:||January 4, 2022 Key Record Dates|
|Last Update Posted:||October 12, 2022|
|Last Verified:||December 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Antineoplastic Agents, Immunological