Solid Tumor, AdultPhase 1NCT05388487
Tolerability and Safety of HF1K16 Injection in Patients With Refractory Solid Tumors
A Phase 1 study testing HF1K16 /Arm 45 mg/m², HF1K16 /Arm 90 mg/m² and HF1K16 /Arm 120 mg/m² in people with Solid Tumor, Adult, run by HighField Biopharmaceuticals Corporation at 7 sites in China.
Trial summary
HF1K16 is an investigational pegylated liposome formulation of All-Trans Retinoic Acid (ATRA) for the induction of remission in patients with acute promyelocytic leukemia (APL) and for the treatment of solid tumors through targeting myeloid derived suppressor cells (MDSCs). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- HF1K16 /Arm 45 mg/m², HF1K16 /Arm 90 mg/m² and HF1K16 /Arm 120 mg/m²
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 7 sitesChina
- Study dates
- 16 Feb 2022to Nov 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide the test of informed consent in writing.
- Male or female, age > 18 years and < = 75 years.
- The subjects had to be diagnosed by histology and/or cytology with locally advanced or metastatic solid tumor. There is no effective standard of care or the patient is intolerant to the standard therapy.
- Cohort 5: The subjects must be diagnosed with glioma by histology, and the disease has relapsed or progressed after previous treatment, and there is no effective standard treatment or the subject is intolerant to standard treatment.
- According to the definition of RECIST 1.1, participants must have at least one measurable lesion.
- Cohort 5: at least one lesion that can be measured in two dimensions is required ( RANO criteria).
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- Eastern group (ECOG) tumor physical state to 0 or 1. Cohort 5: According to Karnofsky physical fitness score ≥ 60.
- Expected lifetime > 12 weeks.
- Men or women of childbearing age must agree to adopt effective contraception after signing the informed consent form until 180 days after the end of the study. Premenopausal women or those within 2 years after menopause are included.
Who cannot join
- Patients received systemic antitumor therapy, including chemotherapy, radiotherapy, biologic therapy, endocrine therapy, or immunotherapy within 3 weeks prior to the first dose, except for the following: Nitrosoureas or mitomycin C within 6 weeks; Oral fluorouracils and small molecule drugs within 2 weeks or within 5 half-life periods of the drug (whichever is longer); Antitumour traditional Chinese medicine within 2 weeks.
- Adverse effects of previous anti-tumor therapy have not recovered to CTCAE 5.0 grade rating of ≤ grade 1 (except for toxicity judged by the investigator be of no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, etc.)
- Patients received other unlisted clinical trial drugs or treatments within 28 days prior to the first dose.
- Taken vitamin A or any vitamin A derivatives within 7 days prior to the first dose.
- Past history of deep vein thrombosis or pulmonary embolism.
- Evidence that there is poor control of thyroid diseases, or diseases of the retina.
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- Patients have symptomatic central nervous system (CNS) metastases, meningeal metastases, or a primary CNS tumor that is associated with progressive neurological symptoms. Except that the brain metastases are shown to be stable judged by imaging examination within 4 weeks.
- Cohort 5: The above criteria do not apply to the fifth cohort. The fifth cohort allowed inhaled or topical corticosteroids, or hormone therapy at physiological replacement doses due to adrenal insufficiency; short-term (≤7 days) corticosteroids were allowed for prophylaxis (eg, contrast media allergy) or treatment of non-autoimmune conditions ( For example, delayed-type hypersensitivity reactions caused by exposure to allergens); systemic corticosteroids (≥10 mg/day prednisone, or other equivalent corticosteroids) for 7 consecutive days within 14 days of the first dose are not allowed or Immunosuppressant therapy.
- Evidences of serious or uncontrolled systemic disease (for example: instability or decompensated respiratory disease, liver or kidney disease)
- Serious liver and kidney function damage;
- Has clinical significance of cardiovascular disease;
- Have known immune inhibitory disease or human immunodeficiency virus (HIV) infection.
- Patients with severe osteoporosis or with bone metastases with serum 25-hydroxyvitamin D assay values less than 50 nmol/L.
- Active hepatitis (Hepatitis B: HBsAg-positive and HBV-DNA ≥ 500 cps/mL or 200 IU/mLL; HCV RNA-positive).
- Persons with known hypersensitivity to any of the active ingredients or excipients or a history of atopic allergic reactions.
- The pregnancy test positive (blood beta human chorionic gonadotropin - HCG [B] test positive) or lactationWomen.
- Researchers believe that patients with combined disease may affect the compliance.
- Participants not willing to or fail to follow the procedure.
- Cohort 5: Brain MRI not available.
- Cohort 5: uncontrolled epilepsy.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Yonggao Mu, +86-13808816691, mouyg@sysucc.org.cn
- Recruiting
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jian LIU, +86-13958054006, lindaliu87@zju.edu.cn
Xiaochen ZHANG, zhangxiaochen@zju.edu.cn
- Recruiting
Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang
Jian CHEN, +86-13588084969, cj21_0503@163.com
Hongming FANG, +86-571-83865832, 3295988078@qq.com
- Recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
Jinsong WU, +86-13701707118, wujinsong@huashan.org.cn
Ruofan HUANG, +86-13701859301, huang_ruofan@fudan.edu.cn
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Weiming Zheng, +86-13706662668, zhwm61@126.com
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Kai Shu, +86-18986292515, kshu@tjh.tjmu.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Xinting Wei, +86-13613860990, weixinting777@126.com
About this study
Official title: A Phase 1 Open-Label Dose-Escalation Study to Evaluate the Tolerability, DLT, Pharmacokinetics, and Preliminary Efficacy of HF1K16 in Patients With Refractory Solid Tumors
HF1K16 is an investigational pegylated liposome formulation of All-Trans Retinoic Acid (ATRA) for the induction of remission in patients with acute promyelocytic leukemia (APL) and for the treatment of solid tumors through targeting myeloid derived suppressor cells (MDSCs).
Read the detailed description
Myeloid Derived Suppressor Cells (MDSCs) play important roles in constituting the immune suppressive environment promoting cancer development and progression. While previous studies had shown that all-trans retinoic acid (ATRA) could induce MDSC differentiation and maturation, the very poor solubility and fast metabolism of the drug limited its applications as an immune-modulator for cancer immunotherapy
HF1K16 is an investigational pegylated liposome formulation with great ATRA dose loading capacity and sustained drug release property. In preclinical studies, HF1K16 was shown to be able to remodel the host systemic immune homeostasis as well as modify tumor microenvironment (TME). It promotes MDSCs maturation into DCs and facilitates immune responses against cancer cells.
- Conditions
- Solid Tumor, Adult
- Being tested
- HF1K16 /Arm 45 mg/m², HF1K16 /Arm 90 mg/m², HF1K16 /Arm 120 mg/m², HF1K16 /Arm 160 mg/m², HF1K16 /Arm 120 mg or 180 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF1K16 /Arm 45 mg/m²Drug
HF1K16 is a liposome suspension containing encapsulated ATRA. Drug concentration is 2mg/ml, and infusion should be completed between 60 minutes and 90 minutes
HF1K16 /Arm 90 mg/m²Drug
HF1K16 is a liposome suspension containing encapsulated ATRA. Drug concentration is 2mg/ml, and infusion should be completed between 60 minutes and 90 minutes
HF1K16 /Arm 120 mg/m²Drug
HF1K16 is a liposome suspension containing encapsulated ATRA. Drug concentration is 2mg/ml, and infusion should be completed between 60 minutes and 90 minutes
HF1K16 /Arm 160 mg/m²Drug
HF1K16 is a liposome suspension containing encapsulated ATRA. Drug concentration is 2mg/ml, and infusion should be completed between 60 minutes and 90 minutes
HF1K16 /Arm 120 mg or 180 mgDrug
HF1K16 is a liposome suspension containing encapsulated ATRA. Drug concentration is 2mg/ml, and infusion should be completed between 60 minutes and 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation cohort 1: HF1K16 given QOD at 45 mg/m² | Experimental | The first dosing group (45 mg/m²) will include a sentinel subject receiving one dose followed by a 7-day safety evaluation interval. Three or more subjects will receive 7 doses of HF1K16 QOD at 45 mg/m2 per cycle of 21 days. Receives: Drug: HF1K16 /Arm 45 mg/m² |
| Dose escalation cohort 2: Oral ATRA followed by HF1K16 QOD at 90 mg/m² | Experimental | The second dosing group will receive oral ATRA at 45mg/m², and three days later HF1K16 QOD at 90 mg/m2 for 7 times per cycle of 21 days. Receives: Drug: HF1K16 /Arm 90 mg/m² |
| Dose escalation cohort 3: HF1K16 QOD at 120 mg/m² | Experimental | The cohort 3 will receive 7 doses of HF1K16 QOD at 120 mg/m² per cycle of 21 days. Receives: Drug: HF1K16 /Arm 120 mg/m² |
| Dose escalation cohort 4: HF1K16 QOD at 160 mg/m² | Experimental | The cohort 4 will receive 7 doses of HF1K16 QOD at 160 mg/m² per cycle of 21 days. Receives: Drug: HF1K16 /Arm 160 mg/m² |
| Dose escalation cohort 5: HF1K16 QOD at 120mg or180 mg | Experimental | The cohort 5 will receive 7 doses of HF1K16 QOD at 120 mg or 180mg per cycle of 21 days. Receives: Drug: HF1K16 /Arm 120 mg or 180 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)
Measured: 30 days after administration
Incidence of dose-limiting toxicities(DLT)
Observe the dose limiting toxicity, and Incidence of dose-limiting toxicities(DLT) will be assessed
Measured: 21 days after administration
Respiration rate of Vital Signs by stethoscope
Changes from baseline for respiration rate in breaths per minute of Vital Signs
Measured: 30 days after administration
Red blood cell count in whole blood sample
Changes from baseline for Red blood cell count in whole blood in10^9 /L
Measured: 30 days after administration
Ventricular rate of ECG
Changes from baseline for ventricular rate in beats per minute
Measured: 30 days after administration
Respiration rate in mg μl/h·g of ECG
Changes from baseline for respiration rate in mg μl/h·g
Measured: 30 days after administration
Heart rate in beats per minute in beats per minute of ECG
Changes from baseline for heart rate in beats per minute
Measured: 30 days after administration
Blood pressure by sphygmomanometer
Changes from baseline for blood pressure in mmHg, both systolic and diastolic pressures will be assessed.
Measured: 30 days after administration
Body temperature by thermometer
Changes from baseline for body temperature in Celsius degree
Measured: 30 days after administration
White blood cell count in whole blood sample
Changes from baseline for white blood cell count in whole blood in 10^9 /L
Measured: 30 days after administration
Neutrophil count in whole blood sample
Changes from baseline for neutrophil count in whole blood in 10^9 /L
Measured: 30 days after administration
Hemoglobin concentration in g/dL in whole blood sample
Changes from baseline for hemoglobin concentration in g/dL in whole blood
Measured: 30 days after administration
Prothrombin time in whole blood sample
Changes from baseline for Prothrombin time in s
Measured: 30 days after administration
International standardized ratio in whole blood sample
Changes from baseline for international standardized ratio
Measured: 30 days after administration
International sensitivity index in whole blood sample
Changes from baseline for international sensitivity index
Measured: 30 days after administration
Activated partial thromboplastin time in whole blood sample
Changes from baseline for activated partial thromboplastin time in s
Measured: 30 days after administration
Total bilirubin concentration in whole blood sample
Changes from baseline for total bilirubin concentration in μmol/L
Measured: 30 days after administration
ALT concentration in whole blood sample
Changes from baseline for alanine aminotransferase(ALT) concentration in U/L
Measured: 30 days after administration
AST concentration in whole blood sample
Changes from baseline for aspartate aminotransferase(AST) concentration in U/L
Measured: 30 days after administration
Total protein concentration in whole blood sample
Changes from baseline for total protein concentration in g/L
Measured: 30 days after administration
Urea concentration in whole blood sample
Changes from baseline for urea concentration in mmol/L
Measured: 30 days after administration
Creatinine concentration in whole blood sample
Changes from baseline for creatinine concentration in μmol/L
Measured: 30 days after administration
Total cholesterol concentration in whole blood sample
Changes from baseline for total cholesterol concentration in mmol/L
Measured: 30 days after administration
Triglycerides concentration in whole blood sample
Changes from baseline for triglycerides concentration in mmol/L
Measured: 30 days after administration
HDL-C in whole blood sample
Changes from baseline for high density lipoprotein cholesterol (HDL-C) in mmol/L
Measured: 30 days after administration
LDL-C in whole blood sample
Changes from baseline for low density lipoprotein cholesterol (LDL-C) in mmol/L
Measured: 30 days after administration
PR interval by ECG
Changes from baseline for PR interval in ms of ECG
Measured: 30 days after administration
QRS by ECG
Changes from baseline for QRS in ms of ECG
Measured: 30 days after administration
QT by ECG
Changes from baseline for QT in ms of ECG
Measured: 30 days after administration
QTc by ECG
Changes from baseline for QTc in ms of ECG
Measured: 30 days after administration
Cohort 5: Determination of overall response rate (ORR) according to RANO criteria
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks
Cohort 5: Duration of response (DOR)
DOR, defined as the time between the start of the subject's first assessment of CR or PR and the first assessment of PD or death from any cause, according to RANO criteria by the investigator
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks
Cohort 5: disease control rate (DCR)
DCR , defined as the proportion of subjects with a best overall response of CR, PR, or SD in the study as assessed by the investigator according to RANO criteria
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks
Cohort 5: progression-free survival (PFS).
PFS, defined as the time between the subject's first dose and the onset of (any aspect of) tumor progression or death from any cause
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks
Secondary outcomes (12)
HF1K16 pharmacokinetic parameters with Cmax
Maximum plasma concentration (Cmax) after administration of HF1K16
Measured: Up to 48 hours postdose
the overall response rate(ORR) of HF1K16
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Measured: Once every six weeks in the first year, then once every 12 weeks afterwards through study completion, an average of 1 year
Peripheral blood mononuclear cells by whole blood sample
Assessing peripheral blood mononuclear cells after dose in cells/mL
Measured: Before injection on Day1,7,13, 21 in each cycle（each cycle is 21 days）
AUC48h by plasma concentration of whole blood sample
Area under plasma concentration -time curve from 0 time ot 48 h(AUC0-48) after dose
Measured: Up to 48 hours postdose
Tmax by plasma concentration of whole blood sample
Peak time (Tmax) after dose
Measured: Up to 48hours postdose
T1/2 by plasma concentration of whole blood sample
Elimination half-life (T1/2) after dose
Measured: Up to 48hours postdose
CL by plasma concentration of whole blood sample
Clearance (CL) after dose
Measured: Up to 48 hours postdose
Vd by plasma concentration of whole blood sample
Volume of distribution(Vd) after dose
Measured: Up to 48 hours postdose
AUClast by plasma concentration of whole blood sample
Ratios of geometric means of AUClast (Area under the plasma concentration-time curve from zero to time of last quantifiable concentration) after dose
Measured: Up to 48 hours postdose
Cohort 5: To assess the changes in MDSC after HF1K16 treatment, including changes in MDSC number
Assessing peripheral blood mononuclear cells after dose in cells/mL
Measured: Before injection on Day1 in each cycle（each cycle is 21 days）
Cohort 5: Incidence of Adverse Events
Defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)
Measured: after administration
Cohort 5: To assess the changes in MDSC after HF1K16 treatment, including changes in MDSC phenotype
Assessment of MDSC phenotype in peripheral blood after drug administration
Measured: Before injection on Day1 in each cycle（each cycle is 21 days）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start16 Feb 2022
- Primary completionApr 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HighField Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Jinsong Wu, MD, Principal investigator, Huashan Hospital Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388487
- Sponsor's protocol ID
- HF1K16-101(CN)
- Status last verified
- Jan 2024
- First submitted
- 4 May 2022
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label Dose-Escalation Study to Evaluate the Tolerability, DLT, Pharmacokinetics, and Preliminary Efficacy of HF1K16 in Patients With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT05388487
- Acronym / sponsor ID
- HF1K16-101(CN)
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- HighField Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 24 May 2022 (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.
HF1K16 is an investigational pegylated liposome formulation of All-Trans Retinoic Acid (ATRA) for the induction of remission in patients with acute promyelocytic leukemia (APL) and for the treatment of solid tumors through targeting myeloid derived suppressor cells (MDSCs).
Detailed description
Myeloid Derived Suppressor Cells (MDSCs) play important roles in constituting the immune suppressive environment promoting cancer development and progression. While previous studies had shown that all-trans retinoic acid (ATRA) could induce MDSC differentiation and maturation, the very poor solubility and fast metabolism of the drug limited its applications as an immune-modulator for cancer immunotherapy
HF1K16 is an investigational pegylated liposome formulation with great ATRA dose loading capacity and sustained drug release property. In preclinical studies, HF1K16 was shown to be able to remodel the host systemic immune homeostasis as well as modify tumor microenvironment (TME). It promotes MDSCs maturation into DCs and facilitates immune responses against cancer cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose escalation cohort 1: HF1K16 given QOD at 45 mg/m² | Experimental | Drug: HF1K16 /Arm 45 mg/m²The first dosing group (45 mg/m²) will include a sentinel subject receiving one dose followed by a 7-day safety evaluation interval. Three or more subjects will receive 7 doses of HF1K16 QOD at 45 mg/m2 per cycle of 21 days. |
| Dose escalation cohort 2: Oral ATRA followed by HF1K16 QOD at 90 mg/m² | Experimental | Drug: HF1K16 /Arm 90 mg/m²The second dosing group will receive oral ATRA at 45mg/m², and three days later HF1K16 QOD at 90 mg/m2 for 7 times per cycle of 21 days. |
| Dose escalation cohort 3: HF1K16 QOD at 120 mg/m² | Experimental | Drug: HF1K16 /Arm 120 mg/m²The cohort 3 will receive 7 doses of HF1K16 QOD at 120 mg/m² per cycle of 21 days. |
| Dose escalation cohort 4: HF1K16 QOD at 160 mg/m² | Experimental | Drug: HF1K16 /Arm 160 mg/m²The cohort 4 will receive 7 doses of HF1K16 QOD at 160 mg/m² per cycle of 21 days. |
| Dose escalation cohort 5: HF1K16 QOD at 120mg or180 mg | Experimental | Drug: HF1K16 /Arm 120 mg or 180 mgThe cohort 5 will receive 7 doses of HF1K16 QOD at 120 mg or 180mg per cycle of 21 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing and able to provide the test of informed consent in writing.
- Male or female, age > 18 years and < = 75 years.
- The subjects had to be diagnosed by histology and/or cytology with locally advanced or metastatic solid tumor. There is no effective standard of care or the patient is intolerant to the standard therapy.
- Cohort 5: The subjects must be diagnosed with glioma by histology, and the disease has relapsed or progressed after previous treatment, and there is no effective standard treatment or the subject is intolerant to standard treatment.
- According to the definition of RECIST 1.1, participants must have at least one measurable lesion.
Key exclusion criteria (20 listed)
- Patients received systemic antitumor therapy, including chemotherapy, radiotherapy, biologic therapy, endocrine therapy, or immunotherapy within 3 weeks prior to the first dose, except for the following: Nitrosoureas or mitomycin C within 6 weeks; Oral fluorouracils and small molecule drugs within 2 weeks or within 5 half-life periods of the drug (whichever is longer); Antitumour traditional Chinese medicine within 2 weeks.
- Adverse effects of previous anti-tumor therapy have not recovered to CTCAE 5.0 grade rating of ≤ grade 1 (except for toxicity judged by the investigator be of no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, etc.)
- Patients received other unlisted clinical trial drugs or treatments within 28 days prior to the first dose.
- Taken vitamin A or any vitamin A derivatives within 7 days prior to the first dose.
- Past history of deep vein thrombosis or pulmonary embolism.
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 |
|---|---|---|
| HF1K16 /Arm 45 mg/m²HF1K16 is a liposome suspension containing encapsulated ATRA. Drug concentration is 2mg/ml, and infusion should be completed between 60 minutes and 90 minutes | Drug | Dose escalation cohort 1: HF1K16 given QOD at 45 mg/m² |
| HF1K16 /Arm 90 mg/m²HF1K16 is a liposome suspension containing encapsulated ATRA. Drug concentration is 2mg/ml, and infusion should be completed between 60 minutes and 90 minutes | Drug | Dose escalation cohort 2: Oral ATRA followed by HF1K16 QOD at 90 mg/m² |
| HF1K16 /Arm 120 mg/m²HF1K16 is a liposome suspension containing encapsulated ATRA. Drug concentration is 2mg/ml, and infusion should be completed between 60 minutes and 90 minutes | Drug | Dose escalation cohort 3: HF1K16 QOD at 120 mg/m² |
| HF1K16 /Arm 160 mg/m²HF1K16 is a liposome suspension containing encapsulated ATRA. Drug concentration is 2mg/ml, and infusion should be completed between 60 minutes and 90 minutes | Drug | Dose escalation cohort 4: HF1K16 QOD at 160 mg/m² |
| HF1K16 /Arm 120 mg or 180 mgHF1K16 is a liposome suspension containing encapsulated ATRA. Drug concentration is 2mg/ml, and infusion should be completed between 60 minutes and 90 minutes | Drug | Dose escalation cohort 5: HF1K16 QOD at 120mg or180 mg |
Primary outcome
Incidence of Adverse Events
Time frame: 30 days after administration
Defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)
Incidence of dose-limiting toxicities(DLT)
Time frame: 21 days after administration
Observe the dose limiting toxicity, and Incidence of dose-limiting toxicities(DLT) will be assessed
Respiration rate of Vital Signs by stethoscope
Time frame: 30 days after administration
Changes from baseline for respiration rate in breaths per minute of Vital Signs
Red blood cell count in whole blood sample
Time frame: 30 days after administration
Changes from baseline for Red blood cell count in whole blood in10^9 /L
Ventricular rate of ECG
Time frame: 30 days after administration
Changes from baseline for ventricular rate in beats per minute
Respiration rate in mg μl/h·g of ECG
Time frame: 30 days after administration
Changes from baseline for respiration rate in mg μl/h·g
Heart rate in beats per minute in beats per minute of ECG
Time frame: 30 days after administration
Changes from baseline for heart rate in beats per minute
Blood pressure by sphygmomanometer
Time frame: 30 days after administration
Changes from baseline for blood pressure in mmHg, both systolic and diastolic pressures will be assessed.
Body temperature by thermometer
Time frame: 30 days after administration
Changes from baseline for body temperature in Celsius degree
White blood cell count in whole blood sample
Time frame: 30 days after administration
Changes from baseline for white blood cell count in whole blood in 10^9 /L
Neutrophil count in whole blood sample
Time frame: 30 days after administration
Changes from baseline for neutrophil count in whole blood in 10^9 /L
Hemoglobin concentration in g/dL in whole blood sample
Time frame: 30 days after administration
Changes from baseline for hemoglobin concentration in g/dL in whole blood
Prothrombin time in whole blood sample
Time frame: 30 days after administration
Changes from baseline for Prothrombin time in s
International standardized ratio in whole blood sample
Time frame: 30 days after administration
Changes from baseline for international standardized ratio
International sensitivity index in whole blood sample
Time frame: 30 days after administration
Changes from baseline for international sensitivity index
Activated partial thromboplastin time in whole blood sample
Time frame: 30 days after administration
Changes from baseline for activated partial thromboplastin time in s
Total bilirubin concentration in whole blood sample
Time frame: 30 days after administration
Changes from baseline for total bilirubin concentration in μmol/L
ALT concentration in whole blood sample
Time frame: 30 days after administration
Changes from baseline for alanine aminotransferase(ALT) concentration in U/L
AST concentration in whole blood sample
Time frame: 30 days after administration
Changes from baseline for aspartate aminotransferase(AST) concentration in U/L
Total protein concentration in whole blood sample
Time frame: 30 days after administration
Changes from baseline for total protein concentration in g/L
Urea concentration in whole blood sample
Time frame: 30 days after administration
Changes from baseline for urea concentration in mmol/L
Creatinine concentration in whole blood sample
Time frame: 30 days after administration
Changes from baseline for creatinine concentration in μmol/L
Total cholesterol concentration in whole blood sample
Time frame: 30 days after administration
Changes from baseline for total cholesterol concentration in mmol/L
Triglycerides concentration in whole blood sample
Time frame: 30 days after administration
Changes from baseline for triglycerides concentration in mmol/L
HDL-C in whole blood sample
Time frame: 30 days after administration
Changes from baseline for high density lipoprotein cholesterol (HDL-C) in mmol/L
LDL-C in whole blood sample
Time frame: 30 days after administration
Changes from baseline for low density lipoprotein cholesterol (LDL-C) in mmol/L
PR interval by ECG
Time frame: 30 days after administration
Changes from baseline for PR interval in ms of ECG
QRS by ECG
Time frame: 30 days after administration
Changes from baseline for QRS in ms of ECG
QT by ECG
Time frame: 30 days after administration
Changes from baseline for QT in ms of ECG
QTc by ECG
Time frame: 30 days after administration
Changes from baseline for QTc in ms of ECG
Cohort 5: Determination of overall response rate (ORR) according to RANO criteria
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Cohort 5: Duration of response (DOR)
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks
DOR, defined as the time between the start of the subject's first assessment of CR or PR and the first assessment of PD or death from any cause, according to RANO criteria by the investigator
Cohort 5: disease control rate (DCR)
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks
DCR , defined as the proportion of subjects with a best overall response of CR, PR, or SD in the study as assessed by the investigator according to RANO criteria
Cohort 5: progression-free survival (PFS).
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks
PFS, defined as the time between the subject's first dose and the onset of (any aspect of) tumor progression or death from any cause
12 secondary outcomes
HF1K16 pharmacokinetic parameters with Cmax
Time frame: Up to 48 hours postdose
the overall response rate(ORR) of HF1K16
Time frame: Once every six weeks in the first year, then once every 12 weeks afterwards through study completion, an average of 1 year
Peripheral blood mononuclear cells by whole blood sample
Time frame: Before injection on Day1,7,13, 21 in each cycle（each cycle is 21 days）
AUC48h by plasma concentration of whole blood sample
Time frame: Up to 48 hours postdose
Tmax by plasma concentration of whole blood sample
Time frame: Up to 48hours postdose
T1/2 by plasma concentration of whole blood sample
Time frame: Up to 48hours postdose
CL by plasma concentration of whole blood sample
Time frame: Up to 48 hours postdose
Vd by plasma concentration of whole blood sample
Time frame: Up to 48 hours postdose
AUClast by plasma concentration of whole blood sample
Time frame: Up to 48 hours postdose
Cohort 5: To assess the changes in MDSC after HF1K16 treatment, including changes in MDSC number
Time frame: Before injection on Day1 in each cycle（each cycle is 21 days）
Cohort 5: Incidence of Adverse Events
Time frame: after administration
Cohort 5: To assess the changes in MDSC after HF1K16 treatment, including changes in MDSC phenotype
Time frame: Before injection on Day1 in each cycle（each cycle is 21 days）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
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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 First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Jinsong Wu, MD principal investigator
Huashan Hospital Shanghai
7 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 HF1K16 /Arm 45 mg/m², HF1K16 /Arm 90 mg/m² and HF1K16 /Arm 120 mg/m² in people with Solid Tumor, Adult, run by HighField Biopharmaceuticals Corporation at 7 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 20 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 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: 30 days after administration). The study lists 34 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 16 Jan 2024.