Advanced Solid TumorPhase 1NCT05169697
A Study to Assess YH002 in Combination with YH001 in Subjects with Advanced Solid Tumors
A Phase 1 study testing A:YH002+YH001, B:YH002+YH001 and YH002+YH001 in people with Advanced Solid Tumor, run by Eucure (Beijing) Biopharma Co., Ltd at 9 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- A:YH002+YH001, B:YH002+YH001 and YH002+YH001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 21 Feb 2022to 4 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for study entry patients must satisfy all of the following criteria:
- Subjects must have the ability to understand and willingness to sign a written informed consent document.
- Subjects must have histologically advanced or cytologically confirmed solid tumor and and must have at least 1 unidimensional measurable lesion by RECIST 1.1.
- 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.
- Subjects must be age 18 to 80 years of age at the time of screening.
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Show all 9Show fewer
- Life expectancy ≥3 months based on investigator's judgement.
- Subjects have adequate bone marrow and other organ function at the screening visit.
- 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.
Who cannot join
- Subjects who meet any of the following criteria cannot be enrolled:
- Subjects have another active invasive malignancy within 5 years.
- Previous exposure to TNFR such as anti-OX40 antibodies.
- 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).
- 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.
- Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.
Show all 9Show fewer
- 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.
- 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
- Subjects must not have active infection of human immunodeficiency virus, hepatitis B, hepatitis C or Covid-19.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
China5 sites
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310020
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200020
Liaoning Cancer Hospital
Shenyang, Liaoning, 110801
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Henan Tumor Hospital
Zhengzhou, Henan, 450008
Australia4 sites
Peninsula and South Eastern Haematology & Oncology Group
Frankston, Victoria, 3199
Cabrini Hospital Malvern
Malvern, Victoria, 3144
Orange Health Services
Orange, New South Wales, 2800
Macquarie University Hospital
Sydney, New South Wales, 2109
About this study
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
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
- Conditions
- Advanced Solid Tumor
- Being tested
- A:YH002+YH001, B:YH002+YH001, YH002+YH001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A:YH002+YH001Drug
YH002 on CnD1,YH001 on CnD8,Q3W
B:YH002+YH001Drug
YH002 and YH001 on same day,Q3W
YH002+YH001Drug
A traditional 3+3 dose escalation algorithm
| Study group | Role | What they receive |
|---|---|---|
| YH002 in combination with YH001 | Experimental | 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. Receives: Drug: A:YH002+YH001; Drug: B:YH002+YH001; Drug: YH002+YH001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 1 year after the last dosing
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
Measured: Up to 1 year after the last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start21 Feb 2022
- Primary completion4 Jul 2023
- Study completion4 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eucure (Beijing) Biopharma Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongming Pan, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169697
- Sponsor's protocol ID
- YH002004
- Status last verified
- Jul 2023
- First submitted
- 10 Dec 2021
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05169697
- Acronym / sponsor ID
- YH002004
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Eucure (Beijing) Biopharma Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 4 Jul 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YH002 in combination with YH001 | Experimental | Drug: A:YH002+YH001, Drug: B:YH002+YH001, Drug: YH002+YH001Dose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must have the ability to understand and willingness to sign a written informed consent document.
- Subjects must have histologically advanced or cytologically confirmed solid tumor and and must have at least 1 unidimensional measurable lesion by RECIST 1.1.
- 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.
- Subjects must be age 18 to 80 years of age at the time of screening.
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (9 listed)
- Subjects have another active invasive malignancy within 5 years.
- Previous exposure to TNFR such as anti-OX40 antibodies.
- 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).
- 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.
- Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A:YH002+YH001YH002 on CnD1,YH001 on CnD8,Q3W | Drug | YH002 in combination with YH001 |
| B:YH002+YH001YH002 and YH001 on same day,Q3W | Drug | YH002 in combination with YH001 |
| YH002+YH001A traditional 3+3 dose escalation algorithm | Drug | YH002 in combination with YH001 |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongming Pan principal investigator
Sir Run Run Shaw Hospital
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A:YH002+YH001, B:YH002+YH001 and YH002+YH001 in people with Advanced Solid Tumor, run by Eucure (Beijing) Biopharma Co., Ltd at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determined the maximum tolerated dose (MTD) (time frame: Up to 1 year after the last dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.