ClinicalTrials.gg
CompletedNCT05169697Updated Jan 6, 2025

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

A Phase 1 interventional study of A:YH002+YH001 and B:YH002+YH001 in Advanced Solid Tumor, sponsored by Eucure (Beijing) Biopharma Co., Ltd. Completed at 9 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-06.

Sponsored by Eucure (Beijing) Biopharma Co., Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Advanced Solid Tumor
03

In context

Lead sponsor

Eucure (Beijing) Biopharma Co., Ltd is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • 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 · Drug: B:YH002+YH001 · Drug: YH002+YH001

Interventions

  • DrugA:YH002+YH001

    YH002 on CnD1,YH001 on CnD8,Q3W

  • DrugB:YH002+YH001

    YH002 and YH001 on same day,Q3W

  • DrugYH002+YH001

    Drug page: Futermestotug

    A traditional 3+3 dose escalation algorithm

06

What researchers measure

Primary outcomes

  1. Determined the maximum tolerated dose (MTD)

    The safety profile of combination treatment will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0

    Time frame: Up to 1 year after the last dosing

  2. Determined the recommended Phase II dose (RP2D)

    The safety profile of combination treatment will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0

    Time frame: Up to 1 year after the last dosing

07

Study locations

9 sites
  • Orange Health Services
    Orange, New South Wales 2800, Australia
  • Macquarie University Hospital
    Sydney, New South Wales 2109, Australia
  • Peninsula and South Eastern Haematology & Oncology Group
    Frankston, Victoria 3199, Australia
  • Cabrini Hospital Malvern
    Malvern, Victoria 3144, Australia
  • Henan Tumor Hospital
    Zhengzhou, Henan 450008, China
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
  • Liaoning Cancer Hospital
    Shenyang, Liaoning 110801, China
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
    Shanghai, Shanghai Municipality 200020, China
  • Sir Run Run Shaw Hospital
    Hangzhou, Zhejiang 310020, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05169697
Lead sponsor
Eucure (Beijing) Biopharma Co., Ltd
Responsible party
Sponsor
First posted
Dec 27, 2021
Start date
Feb 21, 2022
Primary completion
Jul 4, 2023
Completion
Jul 4, 2023
Last update
Jan 6, 2025

Study contacts

Hongming Pan
principal investigator · Sir Run Run Shaw Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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