Locally Advanced/Metastatic Solid TumorsPhase 1NCT04914351
HY-0102 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumours
A Phase 1 study testing HY-0102 in people with Locally Advanced/Metastatic Solid Tumors, run by Shanghai HyaMab Biotech Co.,Ltd. at 3 sites in United States.
Trial summary
This is a Phase I, first-in-human 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced/Metastatic Solid Tumors
- 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
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 May 2022to 30 Dec 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
- Male or female ≥ 18 years
- Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
- Histologically or cytologically confirmed incurable, unresectable, locally advanced or metastatic cancer that is refractory to standard therapies.
- Prior Therapy
- Have progressed on or are intolerant to all standard therapies
- Have no available therapies known to confer clinical benefit
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- Measurable or evaluable disease per RECIST v1.1 Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam.
- ECOG performance status 0 or 1; Life expectancy ≥ 3 months.
- Adequate hepatic function as evidenced by meeting all the following requirements:
- Total bilirubin ≤ 1.5 ×within institutional upper limit of normal (ULN); or ≤ 2.5 × institutional ULN for patients who have serum bilirubin increases due to underlying Gilbert's Syndrome or familial benign.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 × ULN; AST or ALT ≤ 5 × ULN if liver metastases are present.
- Serum creatinine < 1.5 × ULN and calculated creatinine clearance (CrCL) > 30 mL/min (Cockroft-Gault Equation).
- Hematological function defined as:
- Absolute neutrophil count ≥ 1,500//L without growth factor support in the 2 weeks prior to study entry
- Hemoglobin > 9 g/dL without transfusion in the 2 weeks prior to study entry
- Platelet count ≥ 75,000/L without transfusion in the 2 weeks prior to study entry
- Prothrombin time, international normalized ratio or activated partial thromboplastin time < 1.5 × ULN; Use of full dose anticoagulants is permitted. These laboratories should be maintained within the therapeutic range and closely monitored by the Investigator.
- Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy except alopecia, < Grade 2 sensory neuropathy, lymphopenia, and endocrinopathies controlled with hormone replacement therapy.
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception during study treatment that results in a low failure rate of <1% per year when used consistently and correctly. Female and male patient treated with HY-0102 should continue contraception use for 6 months after the last dose. Such methods include combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation together with another additional barrier method always containing a spermicide, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion or vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence.
- Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drug. The same rules are valid for male patients involved in this clinical trial if they have a partner of childbirth potential. Male patients must always use a condom.
- Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 7 days prior to initiation of study drug.
- Women are excluded from birth control if they had had tubal ligation or a hysterectomy.
Who cannot join
- Symptomatic central nervous system metastases. Patients with asymptomatic CNS metastases who are radiologically and neurologically stable ≥ 4 weeks following CNS-directed therapy, and are on a stable or decreasing dose of corticosteroids are eligible for study entry.
- Uncontrolled hypertension (systolic blood pressure >150 mmHg and diastolic blood pressure >90 mmHg), a history of hypertension crisis, or a history of hypertensive encephalopathy.
- Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina within 6 months of study entry; NYHA class III or IV heart failure within 6 months of study entry; Uncontrolled arrhythmia within 6 months of study entry.
- QTc > 450 ms at baseline; no concomitant medications that would prolong the QT interval; no family history of long QT syndrome [consider QTc < 480 rather than 450]
- Concurrent malignancy within 5 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer under active surveillance, prostate cancer that has undergone definitive treatment, ductal carcinoma in situ of the breast, or < T1 urothelial carcinoma.
- Active infection requiring intravenous therapy within 2 weeks prior to entry.
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- Active HIV, hepatitis B or hepatitis C virus. or
- Patients infected with the HIV virus will be eligible if their CD4 count is > 350 cells/mm3 and the patient is on anti-retroviral therapy with an HIV viral load that is below the level of detection.
- Active hepatitis B or C. HBV carriers without active disease (HBV DNA titer < 1000 cps/mL or 200 IU/mL), or cured Hepatitis C (negative HCV RNA test) may be enrolled. For patients with hepatocellular carcinoma, patient with chronic infections with hepatitis C virus (treated or untreated); and patients with hepatitis B virus who were treated with antiviral therapy and who had a HBV viral load less than 200 IU/mL may also be enrolled.
- Active tuberculosis
- Anticancer therapy or radiation therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to study entry; Palliative radiotherapy to a single area of metastasis is within 2 weeks prior to study entry.
- Prior treatment with drugs in the same class.
- Major surgery within 4 weeks prior to study entry; minor surgery within 2 weeks prior to study entry.
- Allergy to study drug or components of its formulation.
- No history of a Grade 3-4 allergic reaction to treatment with another monoclonal antibody.
- Pregnant or breast-feeding females.
- Women of childbearing potential who do not consent to use two highly effective methods of birth control (including one barrier method) during treatment and for an additional 5 half lives after the last administration of study drug.
- Men with a partner of childbearing potential who do not consent to use two highly effective methods of birth control (including one barrier method) during treatment and for an additional 5 half lives after the last administration of study drug.
- Any condition that the investigator or primary physician believes may not be appropriate for participating the study.
- Live virus vaccine within 30 days prior to study entry.
- Active autoimmune disease or history of autoimmune disease requiring systemic therapy within 2 years prior to entry except hypothyroidism, vitiligo, Grave's disease, Hashimoto's disease, or Type I diabetes.
- History of Grade 3-4 immune-related adverse events or immune-related adverse events requiring discontinuation of prior therapies.
- Use of systemic corticosteroids in a dose equivalent to > 10 mg/d of prednisone or other immunosuppressive agent within 2 weeks prior to entry; Use of inhaled, topical, or ophthalmological steroids are allowed. Short term (< 30 days) uses of corticosteroids at doses equivalent to > 10 mg/d of prednisone (e.g., pre-medication for IV contrast) is allowed.
- Prior allogeneic stem cell, bone marrow, or solid organ transplant.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89119
Sarah Cannon Research Institute
Orlando, Florida, 32827
Texas Oncology
Tyler, Texas, 75702
About this study
Official title: A Phase Ⅰ, Multi-center, Open-label, Single-arm, Dose Escalation, First-in-human Clinical Study of HY-0102 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumours
This is a Phase I, first-in-human 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.
Read the detailed description
This is a Phase I, first-in-human 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 (head and neck, liver, colorectal and lung cancers, etc).
Six dosing cohorts are planned with the dose of 0.03, 0.3, 1, 2, 4 and 10 mg/kg. The first two dose levels (0.03 and 0.3 mg/kg) will each enroll one patient using an accelerated escalation design that will convert to a 3+3 design upon the occurrence of one treatment-related Grade 2 toxicity occurring in the safety evaluation window following the first dose of treatment. After the initial two cohorts are completed, the study will use a standard 3+3 dose escalation design.
The number of enrolled patients is estimated to be up to 32. 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.
- Conditions
- Locally Advanced/Metastatic Solid Tumors
- Being tested
- HY-0102
- Keywords
- HY-0102, solid tumors
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 group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Cohort 1: 0.03 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Accelerated dose escalation: One patient will be enrolled. Cohort 2: 0.3 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Accelerated dose escalation: One patient will be enrolled. Cohort 3: 1 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Standard 3+3 Dose escalation: Three patients will be enrolled for each dose cohort.
Cohort 4: 2 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Standard 3+3 Dose escalation: Three patients will be enrolled for each dose cohort.
Cohort 5: 4 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Standard 3+3 Dose escalation: Three patients will be enrolled for each dose cohort.
Cohort 6: 10 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Standard 3+3 Dose escalation: Three patients will be enrolled for each dose cohort. Receives: Drug: HY-0102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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 90 days after the last dose of study drug
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
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
Number of participants with changes in left ventricular ejection fraction (LVEF) 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
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 (15)
Cmax (Maximum observed serum concentration) of HY-0102
Cmax of HY-0102 was observed directly from data
Measured: From first dose through 30days(±7) days after the last dose of study medication
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
Tmax (Time of maximum observed serum concentration) of HY-0102
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
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
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
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
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
CL(Total body clearance) of HY-0102
CL = Dose/AUCinf for Cycle 1 and Dose/AUCtau for Cycle 2. It was reported in units of milliliter per hour per kilogram (mL/hr/kg).
Measured: From first dose through 30(±7) days after the last dose of study medication
Vss (Volume of distribution at steady state) of HY-0102
Vss = CL × MRT, where CL is clearance and MRT is the mean residence time after intravenous administration.
Measured: From first dose through 30(±7) days after the last dose of study medication
Anti-drug Antibody (ADA) and Neutralizing Antibody (NAb)
To assess the immunogenicity of HY-0102
Measured: From first dose through 30(±7) days after the last dose of study medication
ORR (confirmed complete or partial response)
According to the modified RECIST1.1 for immune based therapeutics (iRECIST) 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
DCR (confirmed response or stable disease lasting for at least 6 months)
According to the modified RECIST1.1 for immune based therapeutics (iRECIST) 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
Duration of Response (DoR)
According to the modified RECIST1.1 for immune based therapeutics (iRECIST) 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
Progression Free Survival (PFS)
According to the modified RECIST1.1 for immune based therapeutics (iRECIST) 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
PD parameters: receptor occupancy (RO) of HY-0102
RO of HY-0102 of red blood cells, white blood cells, platelets and neoplastic cells in peripheral blood.
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.
- First posted4 Jun 2021
- Study start3 May 2022
- Primary completion27 Nov 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced/Metastatic Solid TumorsStudies 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
- Model description
- This is a Phase I, first-in-human, single-arm and multi-centre trial to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of HY-0102 in adult patients with locally advanced/metastatic malignant solid tumors.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai HyaMab Biotech Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914351
- Sponsor's protocol ID
- HY-0102-01
- Status last verified
- Apr 2023
- First submitted
- 31 May 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰ, Multi-center, Open-label, Single-arm, Dose Escalation, First-in-human Clinical Study of HY-0102 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumours
- ClinicalTrials.gov ID
- NCT04914351
- Acronym / sponsor ID
- HY-0102-01
- Conditions
- Locally Advanced/Metastatic Solid Tumors
- Keywords
- HY-0102, solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Shanghai HyaMab Biotech Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 May 2022 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 4 Jun 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.
This is a Phase I, first-in-human 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.
Detailed description
This is a Phase I, first-in-human 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 (head and neck, liver, colorectal and lung cancers, etc).
Six dosing cohorts are planned with the dose of 0.03, 0.3, 1, 2, 4 and 10 mg/kg. The first two dose levels (0.03 and 0.3 mg/kg) will each enroll one patient using an accelerated escalation design that will convert to a 3+3 design upon the occurrence of one treatment-related Grade 2 toxicity occurring in the safety evaluation window following the first dose of treatment. After the initial two cohorts are completed, the study will use a standard 3+3 dose escalation design.
The number of enrolled patients is estimated to be up to 32. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a Phase I, first-in-human, single-arm and multi-centre trial to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of HY-0102 in adult patients with locally advanced/metastatic malignant solid tumors.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: HY-0102Cohort 1: 0.03 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Accelerated dose escalation: One patient will be enrolled. Cohort 2: 0.3 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Accelerated dose escalation: One patient will be enrolled. Cohort 3: 1 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Standard 3+3 Dose escalation: Three patients will be enrolled for each dose cohort. Cohort 4: 2 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Standard 3+3 Dose escalation: Three patients will be enrolled for each dose cohort. Cohort 5: 4 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Standard 3+3 Dose escalation: Three patients will be enrolled for each dose cohort. Cohort 6: 10 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Standard 3+3 Dose escalation: Three patients will be enrolled for each dose cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Male or female ≥ 18 years
- Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
- Histologically or cytologically confirmed incurable, unresectable, locally advanced or metastatic cancer that is refractory to standard therapies.
- Prior Therapy
- Measurable or evaluable disease per RECIST v1.1 Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam.
Key exclusion criteria (24 listed)
- Symptomatic central nervous system metastases. Patients with asymptomatic CNS metastases who are radiologically and neurologically stable ≥ 4 weeks following CNS-directed therapy, and are on a stable or decreasing dose of corticosteroids are eligible for study entry.
- Uncontrolled hypertension (systolic blood pressure >150 mmHg and diastolic blood pressure >90 mmHg), a history of hypertension crisis, or a history of hypertensive encephalopathy.
- Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina within 6 months of study entry; NYHA class III or IV heart failure within 6 months of study entry; Uncontrolled arrhythmia within 6 months of study entry.
- QTc > 450 ms at baseline; no concomitant medications that would prolong the QT interval; no family history of long QT syndrome [consider QTc < 480 rather than 450]
- Concurrent malignancy within 5 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer under active surveillance, prostate cancer that has undergone definitive treatment, ductal carcinoma in situ of the breast, or < T1 urothelial carcinoma.
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 |
|---|---|---|
| HY-0102Multiple dose cohorts, 60 minute IV infusion, every two weeks, 28 days as a cycle | Drug | Dose Escalation |
Primary outcome
Occurrence of Drug Limited Toxicities (DLTs)
Time frame: From Time of First dose through DLT observation period, 28 days
To assess by the occurrence of Drug Limited Toxicities (DLTs)
Incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs).
Time frame: From the start of treatment until up to 90 days after the last dose of study drug
To assess by the occurrence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)
Number of patients with changes in laboratory parameters from baseline
Time frame: From the start of treatment until up to 30(±7) days after the last dose of study drug
To assess safety of HY-0102
Number of patients with changes in electrocariogram (ECG) from baseline
Time frame: From the start of treatment until up to 30(±7) days after the last dose of study drug
To assess safety of HY-0102
Number of participants with changes in left ventricular ejection fraction (LVEF) from baseline
Time frame: From the start of treatment until up to 30(±7) days after the last dose of study drug
To assess safety of HY-0102
Number of participants with changes in Clinically Significant Vital Sign from baseline
Time frame: From the start of treatment until up to 30(±7) days after the last dose of study drug
To assess safety of HY-0102
15 secondary outcomes
Cmax (Maximum observed serum concentration) of HY-0102
Time frame: From first dose through 30days(±7) days after the last dose of study medication
Ctrough (Trough observed serum concentration) of HY-0102
Time frame: From first dose through 30(±7) days after the last dose of study medication
Tmax (Time of maximum observed serum concentration) of HY-0102
Time frame: From first dose through 30(±7) days after the last dose of study medication
AUC(0-T) [Area under the concentration-time curve from time zero to the last quantifiable concentration] of HY-0102
Time frame: From first dose through 30(±7) days after the last dose of study medication
AUC(tau) [Area under the concentration-time curve in one dosing interval] of HY-0102
Time frame: From first dose through 30(±7) days after the last dose of study medication
AUC(inf) [Area under the concentration-time curve from time zero to infinity and the extrapolated area] of HY-0102
Time frame: From first dose through 30(±7) days after the last dose of study medication
T1/2 (Elimination half life) of HY-0102
Time frame: From first dose through 30 days (+/- 7 days) after the last dose of study medication
CL(Total body clearance) of HY-0102
Time frame: From first dose through 30(±7) days after the last dose of study medication
Vss (Volume of distribution at steady state) of HY-0102
Time frame: From first dose through 30(±7) days after the last dose of study medication
Anti-drug Antibody (ADA) and Neutralizing Antibody (NAb)
Time frame: From first dose through 30(±7) days after the last dose of study medication
ORR (confirmed complete or partial response)
Time frame: FU period/EOS visits every 3 months (± 14 days) after the EOT visit for 6 months
DCR (confirmed response or stable disease lasting for at least 6 months)
Time frame: FU period/EOS visits every 3 months (± 14 days) after the EOT visit for 6 months
Duration of Response (DoR)
Time frame: FU period/EOS visits every 3 months (± 14 days) after the EOT visit for 6 months
Progression Free Survival (PFS)
Time frame: FU period/EOS visits every 3 months (± 14 days) after the EOT visit for 6 months
PD parameters: receptor occupancy (RO) of HY-0102
Time frame: From first dose through 30(±7) days after the last dose of study medication
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 13 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HY-0102 in people with Locally Advanced/Metastatic Solid Tumors, run by Shanghai HyaMab Biotech Co.,Ltd. at 3 sites in United States.
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 22 inclusion and 24 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 13 Mar 2024. 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 United States. 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?
Occurrence of Drug Limited Toxicities (DLTs) (time frame: From Time of First dose through DLT observation period, 28 days). The study lists 6 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 13 Mar 2024.