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A Study to Assess YH002 in Combination With YH001 in Subjects With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT05169697
Recruitment Status : Recruiting
First Posted : December 27, 2021
Last Update Posted : July 22, 2022
Information provided by (Responsible Party):
Eucure (Beijing) Biopharma Co., Ltd

Brief Summary:
A multicenter, open-label, phase I dose escalation study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YH002 in combination with YH001 in subjects with advanced solid tumors

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: A:YH002+YH001 Drug: B:YH002+YH001 Drug: YH002+YH001 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YH002 in Combination With YH001 in Subjects With Advanced Solid Tumors
Actual Study Start Date : February 21, 2022
Estimated Primary Completion Date : February 21, 2024
Estimated Study Completion Date : February 21, 2025

Arm Intervention/treatment
Experimental: YH002 in combination with YH001
Dose escalation:A traditional 3+3 dose escalation algorithm will be utilized to identify MTD and/or RP2D Dose expansion:One selected dose after the escalation stage will be expanded to enroll additional 20 subjects. The subjects will be divided into two groups:A and B.
Drug: A:YH002+YH001
YH002 on CnD1,YH001 on CnD8,Q3W

Drug: B:YH002+YH001
YH002 and YH001 on same day,Q3W

Drug: YH002+YH001
A traditional 3+3 dose escalation algorithm

Primary Outcome Measures :
  1. Determined the maximum tolerated dose (MTD) [ Time Frame: Up to 1 year after the last dosing ]
    The safety profile of combination treatment will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0

  2. Determined the recommended Phase II dose (RP2D) [ Time Frame: Up to 1 year after the last dosing ]
    The safety profile of combination treatment will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

To be eligible for study entry patients must satisfy all of the following criteria:

  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 and and must have at least 1 unidimensional measurable lesion by RECIST 1.1.
  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. Subjects must be age 18 to 80 years of age at the time of screening.
  5. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. Life expectancy ≥3 months based on investigator's judgement.
  7. Subjects have adequate bone marrow and other organ function at the screening visit.
  8. Women of reproductive potential must have negative serum beta human chorionic gonadotropin (β -HCG) pregnancy test within 7 days of the first dosing. Women of reproductive potential are those who have not been post-menopausal for at least 12 months or who have not undergone bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy.

Exclusion Criteria:

Subjects who meet any of the following criteria cannot be enrolled:

  1. Subjects have another active invasive malignancy within 5 years.
  2. Previous exposure to TNFR such as anti-OX40 antibodies.
  3. Subjects must not have received any anticancer therapy or another investigational agent within the shorter of 4 weeks or 5 half-lives before the first dose of the study treatment(subject to the longer one).
  4. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that have not recovered to ≤ Grade 1 per CTCAE 5.0, except alopecia ≤ Grade 2.
  5. Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.
  6. Subjects must not have a known or suspected history of an autoimmune disorder, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment.
  7. Clinically uncontrolled intercurrent illness, including but not limit to an ongoing active infection, active coagulopathy, uncontrolled diabetes (blood glucose > 250 mg/dl), uncontrolled pleural and peritoneal effusion, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies
  8. Subjects must not have active infection of human immunodeficiency virus, hepatitis B, hepatitis C or Covid-19.

Information from the National Library of Medicine

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): NCT05169697

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Contact: Fangxia Pan +86 01085950770 ext 8006 fangxia.pan@eucure.com

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Australia, New South Wales
Orange Health Services Recruiting
Orange, New South Wales, Australia, 2800
Contact: Robert Zielinski    63693380 ext +02    rob.zielinski@health.nsw.gov.au   
Macquarie University Hospital Active, not recruiting
Sydney, New South Wales, Australia, 2109
Australia, Victoria
Peninsula and South Eastern Haematology & Oncology Group Recruiting
Frankston, Victoria, Australia, 3199
Contact: Vinod Ganju    91131307 ext +61    ag@paso.com   
Cabrini Hospital Malvern Active, not recruiting
Malvern, Victoria, Australia, 3144
China, Henan
Henan Tumor Hospital Not yet recruiting
Zhengzhou, Henan, China, 450008
Contact: Suxia Luo    18638553211    luosxrm@163.com   
China, Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Not yet recruiting
Wuhan, Hubei, China, 430022
Contact: Tao Zhang    13808640033    1277577866@qq.com   
China, Liaoning
Liaoning Cancer Hospital Not yet recruiting
Shenyang, Liaoning, China, 110801
Contact: Tao Sun    1890091 7877    lnzlrxnsy@163.com   
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Not yet recruiting
Shanghai, Shanghai, China, 200020
Contact: Yan Shi    13810561979    sy_rjh@aliyun.com   
China, Zhejiang
Sir Run Run Shaw Hospital Recruiting
Hangzhou, Zhejiang, China, 310020
Contact: Hongming Pan    13605716662    panhongming@zju.edu.cn   
Sponsors and Collaborators
Eucure (Beijing) Biopharma Co., Ltd
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Principal Investigator: Hongming Pan Sir Run Run Shaw Hospital
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Responsible Party: Eucure (Beijing) Biopharma Co., Ltd
ClinicalTrials.gov Identifier: NCT05169697    
Other Study ID Numbers: YH002004
First Posted: December 27, 2021    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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