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Advanced Solid TumorPhase 1NCT06094777

A Study of HY-0102 in Patients With Advanced Solid Tumors

A Phase 1 study testing HY-0102 in people with Advanced Solid Tumor, run by Shanghai YingLi Pharmaceutical Co. Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase 1 open label multicenter study to evaluate the maximum tolerance, safety, tolerance and PK of HY-0102 administered intravenously (IV) once every two weeks in patients with advanced solid tumors, so as to confirm the recommended phase 2 dose of HY-0102 and obtain the preliminary efficacy information of… 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?
HY-0102
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
18 Dec 2023to Dec 2025
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

  • -
  • Participants must meet the following criteria to be considered for inclusion in the study:
  • Demonstrated willingness to voluntarily provide a signed informed consent document.
  • Male or female individuals aged ≥18 years.
  • Advanced malignant solid tumor patients who have experienced treatment failure using established therapeutic methods, have no viable standard treatment options available, or are unable to tolerate standard therapy. (Preference will be given to patients with urothelial carcinoma, colorectal cancer, and pancreatic cancer)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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  • Anticipated minimum survival duration of 3 months.
  • Measurable or evaluable lesions detected by CT/MRI scans; participants in the dose expansion phase must have quantifiable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). Measurable lesions may also include those located in previously irradiated (or subjected to other local therapy) areas, demonstrating evident progression as confirmed by post-radiation therapy imaging.
  • Participants must meet the following laboratory criteria with adequate organ and bone marrow function prior to enrollment:
  • 1) Bone marrow reserve (no blood transfusion or blood product administration within 14 days preceding the first dose, absence of the use of G-CSF or other hematopoietic growth factors for correction): Absolute neutrophil count (ANC) ≥1.5×109/L, white blood cell count (WBC) ≥3.0×109/L, hemoglobin (HB) ≥90 g/L, platelet count (PLT) ≥100×109/L (patients with hepatocellular carcinoma (HCC) may have PLT ≥75×109/L); 2) Liver function: Alanine transaminase (ALT) ≤3×upper limit of normal (ULN), aspartate transaminase (AST) ≤3×ULN, alkaline phosphatase (ALP) ≤2.5×ULN, total bilirubin (TBIL) ≤1.5×ULN (patients with known Gilbert's syndrome and serum bilirubin level ≤3 times ULN can be included), liver metastasis patients: ALT ≤5×ULN, AST ≤5×ULN, ALP ≤5×ULN); 3) Renal function: Creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min calculated using the Cockcroft-Gault formula; 4) Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN (for patients not on anticoagulant therapy, inclusion can be determined by the investigator); 8. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to utilize highly effective contraception methods throughout the treatment period (with a failure rate of less than 1% when used correctly and consistently). Participants receiving HY-0102 treatment should continue contraception for 6 months following the final dose administration. Acceptable contraceptive methods include combined hormonal contraception (including estrogen or progestogen), progestogen-only pills primarily inhibiting ovulation when combined with another barrier method (typically containing a spermicide), intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomy, and sexual abstinence.
  • Considering potential interactions between the investigational drug and oral contraceptives, oral contraceptives should always be combined with alternative contraceptive methods. This requirement also applies to male participants with partners of childbearing potential, who must utilize condoms.
  • Non-menopausal (non-treatment-related amenorrhea for ≥12 months) or non-sterilized female participants must obtain a negative serum pregnancy test result within 7 days prior to initiating the study drug.
  • Women who have undergone tubal ligation or hysterectomy are exempt from contraception requirements.
  • 9. Participants must have sufficiently recovered from all acute toxicities resulting from previous treatment (recovery to Grade 1 or below), excluding alopecia, hyperpigmentation, peripheral neuropathy recovered to <CTCAE Grade 2, and long-term toxicities caused by radiation therapy, at the discretion of the investigator.

Who cannot join

  • -
  • Participants will be excluded if they meet any of the following criteria:
  • Allergies or hypersensitivity to any component of the investigational product.
  • Severe or uncontrolled cardiac diseases, congestive heart failure graded as III or IV according to the New York Heart Association (NYHA), unstable angina that cannot be controlled with medication, history of myocardial infarction within the previous 6 months, or severe arrhythmias requiring medication (excluding atrial fibrillation or paroxysmal supraventricular tachycardia).
  • Active seizures requiring antiepileptic drugs, recent (< 6 months) cerebrovascular accidents or transient ischemic attacks.
  • Symptomatic brain metastases or untreated brain metastases meeting at least one of the following criteria:
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  • Requires the use of corticosteroids or dehydration therapy (excluding antiepileptic drugs after surgery or radiation therapy);
  • Presents with clinically significant symptoms;
  • Tumor stability lasting less than 4 weeks after radiation therapy or surgery.
  • Requires oxygen therapy for daily activities; asthma requiring medical intervention with bronchodilators.
  • Peripheral neuropathy of Grade ≥2.
  • Received any chemotherapy, hormonal therapy, radiation therapy, immunotherapy, or biological therapy within 4 weeks prior to the first dose of the investigational treatment, or within 5 half-lives of the previous treatment, whichever is shorter. The following exceptions are allowed:
  • Local topical or inhaled corticosteroids;
  • Short-term (≤7 days) use of corticosteroids for prophylaxis or treatment of non-autoimmune allergy disorders;
  • Local palliative radiation therapy for bone metastases.
  • Underwent major surgery within 4 weeks prior to enrollment or has not fully recovered from previous surgery (definition of major surgery according to the "Management Measures for Clinical Application of Medical Technologies" implemented on May 1, 2009) or anticipates significant surgery within 28 days during the study.
  • Participants with autoimmune diseases or history of autoimmune diseases, including but not limited to inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis (participants with resolved childhood asthma or vitiligo without any intervention in adulthood may be included).
  • Active viral, bacterial, fungal, or other infections requiring systemic treatment (excluding onychomycosis).
  • Active hepatitis B (positive for hepatitis B surface antigen and/or positive for hepatitis B core antibody with HBV-DNA ≥10^4 copies/mL or ≥2000 IU/mL), active hepatitis C (positive for hepatitis C virus antibodies and/or positive for HCV-RNA), or positive HIV test.
  • Severe infection within 4 weeks prior to first dose administration or active infection requiring oral or intravenous antibiotic treatment within the past 2 weeks as determined by the investigator.
  • Participants with severe concurrent chronic or acute diseases (e.g., cardiovascular or pulmonary diseases, liver diseases, or diseases that the investigator considers as high risk for experimental drug treatment).
  • History of any malignancy within the past 3 years, with the exception of cured basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, cervical carcinoma in situ, or primary lung adenocarcinoma.
  • Vaccination with a live attenuated vaccine within 4 weeks prior to the first dose of study medication or planned administration during the study period.
  • Pregnancy or breastfeeding.
  • Left ventricular ejection fraction (LVEF) <45% as shown on transthoracic echocardiography (ECHO) or multiple gated acquisition (MUGA) scanning.
  • Fridericia-corrected QT interval (QTcF) >480 milliseconds.
  • The investigator believes that there are clinically significant conditions or factors that may affect compliance with the treatment regimen, the participant's ability to provide informed consent, or suitability for participation in the clinical trial.

Trial locations and contacts

1 site in 1 country.

Dingwei Ye, PhD contact

13701663571

dwyeli@163.com

Jian Zhang, PhD contact

18017312991

syner2000@163.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Jian Zhang, 18017312991, dwyeli@163.com

    Dingwei Ye

    Recruiting

Other trials in China

About this study

Official title: A Phase 1, Multicenter, Open-label, Dose-escalation and Dose-expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HY-0102 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumors

This is a phase 1 open label multicenter study to evaluate the maximum tolerance, safety, tolerance and PK of HY-0102 administered intravenously (IV) once every two weeks in patients with advanced solid tumors, so as to confirm the recommended phase 2 dose of HY-0102 and obtain the preliminary efficacy information of patients with advanced solid tumors.

Read the detailed description

This is a Phase I trial to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of HY-0102 administered intravenously (IV) once every two weeks in adult patients with locally advanced/metastatic malignant solid tumors (urothelial carcinoma, colorectal and pancreatic cancers, etc).

Three dosing cohorts are planned with the doses of 5, 10 and 15 mg/kg. The study will apply a standard 3+3 dose escalation design in dose escalation.Dose expansion will enroll approximately 30-40 cases of tumor types that have demonstrated preliminary efficacy in the early escalation phase.

The number of enrolled patients is estimated to be up to 50. The dose limiting toxicity evaluation period will be the first 28 days (Cycle 1) and subsequent cycles will be 4 weeks in duration. Patients will receive the investigational drug on Day 1 of cycle 1 followed by 28 days of observation. HY-0102 will be administered IV once every two weeks for Cycle 2 and beyond.

Being tested
HY-0102
Keywords
Urothelial carcinoma, Colorectal cancer, Pancreatic cancer, NKG2A, Humanized monoclonal antibody
Medical subject headings
Carcinoma, Transitional Cell, Colorectal Neoplasms, Pancreatic Neoplasms

What participants receive

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

  • HY-0102Drug

    Multiple dose cohorts, 60 minute IV infusion, every two weeks, 28 days as a cycle

Study groups in NCT06094777
Study groupRoleWhat they receive
HY-0102ExperimentalDose Escalation(Standard 3+3 Dose escalation) Cohort 1: 5 mg/kg Q2W HY-0102 ivgtt Duration: 24w,DLT observation period: 28 days. Cohort 2: 10 mg/kg Q2W HY-0102 ivgtt Duration: 24w,DLT observation period: 28 days. Cohort 3: 15 mg/kg Q2W HY-0102 ivgtt Duration: 24w,DLT observation period: 28 days. Dose Expansion Within the MTD and sub-MTD dose groups, select 1-2 doses for dose expansion, including approximately 30-40 cases of tumor types that have demonstrated preliminary efficacy in the early escalation phase. Conduct safety, tolerability, and preliminary anti-tumor efficacy evaluations to provide a basis for the recommended phase II clinical dose (RP2D). PK studies will be conducted on 12 subjects in each dose group, including dose escalation trial cases.
Receives: Drug: HY-0102

What is being measured

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

  1. Occurrence of drug limited toxicities (DLTs)

    To assess by the occurrence of Drug Limited Toxicities (DLTs)

    Measured: From Time of First dose through DLT observation period, 28 days

  2. Incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)

    To assess by the occurrence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)

    Measured: From the start of treatment until up to 30(±7) days after the last dose of study drug

  3. Number of patients with changes in laboratory parameters from baseline

    To assess safety of HY-0102

    Measured: From the start of treatment until up to 30(±7) days after the last dose of study drug

  4. Number of patients with changes in electrocariogram (ECG) from baseline

    To assess safety of HY-0102

    Measured: From the start of treatment until up to 30(±7) days after the last dose of study drug

  5. Number of participants with changes in clinically significant vital sign from baseline

    To assess safety of HY-0102

    Measured: From the start of treatment until up to 30(±7) days after the last dose of study drug

Secondary outcomes (12)

  1. ORR (confirmed complete or partial response)

    The overall response rate (ORR) will be estimated based on the proportion of evaluable patients whose overall response (ORR) during study treatment is CR or PR. Disease response will be assessed by the investigator using RECIST v1.1

    Measured: FU period/EOS visits every 3 months (± 14 days) after the EOT visit for 12 months

  2. DCR (confirmed response or stable disease lasting for at least 6 months)

    According to the RECIST v1.1 to assess anti-tumor activity of HY-0102

    Measured: FU period/EOS visits every 3 months (± 14 days) after the EOT visit for 12 months

  3. Duration of Response (DoR)

    According to the RECIST v1.1 to assess anti-tumor activity of HY-0102

    Measured: FU period/EOS visits every 3 months (± 14 days) after the EOT visit for 12 months

  4. Progression Free Survival (PFS)

    According to the RECIST v1.1 to assess anti-tumor activity of HY-0102

    Measured: FU period/EOS visits every 3 months (± 14 days) after the EOT visit for 6 months

  5. Cmax (Maximum observed serum concentration) of HY-0102

    Cmax of HY-0102 is observed directly from data

    Measured: From first dose through 30days(±7) days after the last dose of study medication

  6. Ctrough (Trough observed serum concentration) of HY-0102

    Ctrough of HY-0102 was observed directly from data.

    Measured: From first dose through 30(±7) days after the last dose of study medication

  7. Tmax(Time to maximum plasma concentration)

    Tmax of HY-0102 was observed directly from data as time of Cmax.

    Measured: From first dose through 30(±7) days after the last dose of study medication

  8. AUC(0-T) [Area under the concentration-time curve from time zero to the last quantifiable concentration] of HY-0102

    AUClast of HY-0102 was determined by linear/log trapezoidal method.

    Measured: From first dose through 30(±7) days after the last dose of study medication

  9. AUC(tau) [Area under the concentration-time curve in one dosing interval] of HY-0102

    AUCtau of HY-0102 was determined using linear/log trapezoidal method.

    Measured: From first dose through 30(±7) days after the last dose of study medication

  10. AUC(inf) [Area under the concentration-time curve from time zero to infinity and the extrapolated area] of HY-0102

    AUCinf = AUClast + (Clast*/kel), where Clast* is the estimated concentration at the time of the last measurable concentration and kel is the terminal phase rate constant calculated as the absolute value of the slope of a linear regression during the terminal phase of the natural log-transformed concentration time profile.

    Measured: From first dose through 30(±7) days after the last dose of study medication

  11. T1/2 (Elimination half life) of HY-0102

    T1/2 of HY-0102 was observed directly from data.

    Measured: From first dose through 30 days (+/- 7 days) after the last dose of study medication

  12. Anti-drug Antibody (ADA)

    To assess the immunogenicity of HY-0102

    Measured: From first dose through 30(±7) days after the last dose of study medication

Timeline

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

  1. First posted23 Oct 2023
  2. Study start18 Dec 2023
  3. Primary completionJun 2025 (estimated)
  4. Study completionDec 2025 (estimated)

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
Sequential
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06094777
Sponsor's protocol ID
YL-0102-02
Status last verified
Oct 2023
First submitted
16 Oct 2023
Last updated
13 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HY-0102 in people with Advanced Solid Tumor, run by Shanghai YingLi Pharmaceutical Co. Ltd. at 1 site 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 14 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dingwei Ye, PhD (13701663571, dwyeli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of drug limited toxicities (DLTs) (time frame: From Time of First dose through DLT observation period, 28 days). The study lists 5 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 NCT06094777.

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 13 Jun 2024.

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