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Advanced Solid TumorsPhase 1NCT04699929

A Study to Evaluate YH001 in Subjects With Advanced Solid Tumors

A Phase 1 study testing YH001 in people with Advanced Solid Tumors, run by Eucure (Beijing) Biopharma Co., Ltd at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, dose-escalation study of the study drug YH001 . The study is designed to determine the safety, tolerability and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of 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 Tumors
What is being tested?
YH001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
3 sitesChina
Study dates
26 Jan 2021to 8 Oct 2022
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

  • Male or female, aged ≥ 18 years;
  • Patients with histologically or cytologically confirmed solid tumors who have failed standard of care or have no standard of care;
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1;
  • Have life expectancy of at least 3 months based on investigator's judgement;
  • Organ function levels must meet the following requirements:
  • A:Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count ≥ 100 x 10^9/L, hemoglobin (Hb) ≥ 100 g/L ; B:Liver: serum total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (patients with primary liver cancer or liver metastases: AST and/or ALT < 5 × ULN); C:Kidney: creatinine clearance (CrCL) ≥ 50 mL/min;
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  • International normalized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN, activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN;
  • All women of reproductive potential, men whose partner is a woman of reproductive potential, or their spouses should use adequate barrier contraception throughout the study and for 3 months after the last dose;
  • Voluntary and agree to sign the informed consent and follow the study treatment protocol as well as follow-up plan.

Who cannot join

  • Subjects with prior anti-CTLA-4 checkpoint inhibitors should be excluded;
  • Patients with any other malignancy within the past 5 years or currently, except for completely cured non-melanoma skin cancer, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast;
  • Received other anti-tumor therapies (such as chemotherapy, radiotherapy, surgery, endocrine therapy, targeted therapy, immunotherapy, etc.) within 4 weeks or 5 half-lives (whichever is longer) before the first dose, or received modern Chinese medicine preparations with anti-tumor effect approved by NMPA within 2 weeks prior to the first dose;
  • Major surgery (excluding vascular access establishment surgery) was received within 4 weeks prior to the first dose;
  • Has received immunosuppressive therapy within 4 weeks prior to the first dose. However, enrollment is permitted under the following circumstances:
  • In the absence of active autoimmune disease, patients are allowed to receive inhaled or topical glucocorticoids, or other glucocorticoids at doses ≤ 10 mg/day prednisone equivalent.
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  • Patients with primary central nervous system (CNS) tumors, or symptomatic CNS tumors, or spinal cord compression, or carcinomatous meningitis; with the following exceptions:
  • Patients with asymptomatic brain metastases (i.e., no progressive central nervous system symptoms due to brain metastatic sites, no need for corticosteroids, and lesion size ≤ 1.5 cm); Patients whose symptoms are controlled by treatment, i.e., their condition is stable and asymptomatic at least 4 weeks after treatment;
  • Use of any other study drug within 4 weeks prior to the first dose, or participation in other clinical studies;
  • Have received live or attenuated vaccines within 4 weeks prior to the first dose;
  • Patients with known severe allergic reactions (≥ Grade 3) to the active ingredient and excipients of the investigational drug, other monoclonal antibodies or "Immuno-oncology drugs;
  • Toxic and side effects caused by prior anti-tumor therapy before the first dose did not recover to ≤ Grade 1 (CTCAE v5.0), except for alopecia and sensory neuropathy below Grade 2;
  • History of interstitial pneumonia or non-infectious pneumonitis requiring corticosteroids, except for radiation therapy, or current presence of interstitial pneumonia or non-infectious pneumonitis;
  • ≥ Grade 2 immune-related pneumonitis occurred during prior immunotherapy;
  • History of ≥ Grade 3 immune-related adverse reactions or any adverse reactions leading to discontinuation of immunotherapy during prior immunotherapy;
  • Past or existing active tuberculosis ;
  • Patients with active auto-immune disease, history of auto-immune disease requiring systemic therapy, or history of auto-immune disease within 2 years prior to the first dose, with the following exceptions: leucoderma, childhood asthma/specific reactions, type I diabetes mellitus, hypothyroidism which can be treated with replacement therapy;
  • Clinically uncontrollable disease, including, but not limited to, severe diabetes (fasting glucose > 250 mg/dl,1 mg/dl = 18 mmol/L), uncontrollable hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg), or other serious disease requiring systemic treatment;
  • Patients with active infections, including active hepatitis B, active hepatitis C, and human immunodeficiency virus infection;
  • Patients with active infection requiring intravenous infusion;
  • Serious cardiovascular and cerebrovascular diseases, such as cerebrovascular rupture, stroke, myocardial infarction, unstable angina pectoris, congestive heart failure (New York Heart Association Grade ≥ II), severe uncontrolled arrhythmia, etc., occurred within 6 months prior to the first dose;
  • Patients with clinically significant ECG abnormalities: QTcF ≥ 470 msec (corrected by Fridericia), or having history of congenital long QT syndrome, or taking any known QTc prolonging medication;
  • Patients who have received allogeneic bone marrow transplant or organ transplant;
  • Known psychiatric disorders, drug abuse, drug use, or alcohol dependence that may affect trial compliance;
  • Other conditions that were considered not suitable for the study by the investigator.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • West China Hospital,Sichuan University

    Chengdu, Sichuan, 610041

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

Other trials in China

About this study

Official title: A Open-Label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability,Efficacy and Pharmacokinetics of YH001 in Subjects With Advanced Solid Tumors

This is an open-label, dose-escalation study of the study drug YH001 . The study is designed to determine the safety, tolerability and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of YH001 in subjects with advanced solid tumors.

Read the detailed description

This is a single arm clinical trial in subjects with advanced solid tumor receiving multiple doses of YH001 intravenously (IV). YH001 will be administered (IV) in 19-37 patients with advanced solid tumors. An accelerated titration method followed by a traditional 3+3 dose escalation scheme will be utilized to determine MTD(maximum tolerated dose) and/or RP2D(recommended phase 2 dose). Patients will be dosed at Dose A, Dose B, Dose C, Dose D, Dose E, Dose F and Dose G every 3 weeks (Q3W) for 15 weeks (5 cycles).

Being tested
YH001

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YH001Drug

    YH001 will be administered intravenously over 60minutes every three weeks (Q3W) for up to 1 years .

Study groups in NCT04699929
Study groupRoleWhat they receive
Intervention/treatmentExperimentalAll subject will receive YH001 intravenously as single agent every three weeks (Q3W) for up to 1 years, until intolerable toxicity, confirmed disease progression, withdrawal of consent, or Investigator decision, whichever comes first.
Receives: Drug: YH001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall safety and tolerability profile of YH001 (adverse events)

    The safety profile of YH001 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

    Measured: From screening up to 1 year

  2. Maximum tolerated dose (MTD)

    The MTD will be determined based on the data of safety and tolerability

    Measured: Cycle 1 of each cohort. Duration of one cycle is 21 day

  3. Recommended phase 2 dose (RP2D)

    The RP2D will be determined based on the data of safety and tolerability

    Measured: Cycle 1 of each cohort. Duration of one cycle is 21 day

Secondary outcomes (4)

  1. Maximum serum concentration (Cmax)

    To determine the PK profile of YH001

    Measured: Up to 1 year

  2. Trough concentration before the next dose is administered (Ctrough)

    To determine the PK profile of YH001

    Measured: Up to 1 year

  3. Time to reach maximum serum concentration (Tmax)

    To determine the PK profile of YH001

    Measured: Up to 1 year

  4. Clearance (CL)

    To determine the PK profile of YH001

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2021
  2. Study start26 Jan 2021
  3. Primary completion8 Oct 2022
  4. Study completion8 Oct 2022

Resources

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04699929
Sponsor's protocol ID
YH001003
Status last verified
May 2022
First submitted
30 Dec 2020
Last updated
12 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YH001 in people with Advanced Solid Tumors, run by Eucure (Beijing) Biopharma Co., Ltd at 3 sites in China.

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 25 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 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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?

Overall safety and tolerability profile of YH001 (adverse events) (time frame: From screening up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04699929.

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 12 Dec 2022.

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