Advanced Solid Tumor MalignanciesPhase 1/2NCT06649708
HX044,FIH Study in Patients with Advanced Solid Tumor Malignancies
A Phase 1/2 study testing HX044 in people with Advanced Solid Tumor Malignancies, run by Hanx Biopharmaceuticals (Wuhan) Co., Ltd. at 3 sites in Australia.
Trial summary
The study will consist of a dose-escalation and dose-expansion component to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and to evaluate the preliminary antitumor activity of HX044. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor Malignancies
- What is being tested?
- HX044
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesAustralia
- Study dates
- 30 Dec 2024to 31 Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Subjects must voluntarily agree to participate by providing written informed consent and agreeing to comply with protocol and scheduled visit;
- Male or female subject aged 18-75 years, inclusive;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- Histologically confirmed advanced malignant solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.
- At least 1 measurable tumor (It is acceptable to allow patients with no measurable lesion but evaluable tumor lesion in the first 2 dose levels in Phase I and at least 1 measurable tumor lesion must be present in Phase IIa) according to RECIST v1.1
- Life expectancy ≥ 12 weeks.
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- Adequate organ function, as indicated by the following laboratory values: •Hematology (no growth factor and blood transfusion are allowed within 14 days before start of first dose study treatment): Hemoglobin ≥90g/L Absolute neutrophil count ≥1.5×109/L Platelet count ≥100×109/L
- Hepatic: Serum total bilirubin ≤1.5 × upper limit of normal (ULN); or direct bilirubin ≤ULN for patients with total bilirubin levels >1.5 × ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (ALT and AST ≤ 5 × ULN for subjects with liver metastases)
- Renal:Serum creatinine ≤1.5 × ULN
- Coagulation: Prothrombin time/international normalized ratio ≤1.5 × ULN or activated partial thromboplastin time ≤ 1.5 × ULN (for subjects on anticoagulants, prothrombin time or activated partial thromboplastin time must be within the normal range foranticoagulants).
Who cannot join
- Prior malignancy active within the previous 5 years except for the tumor for which a subject is enrolled in the study and locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
- Receipt of any anticancer (chemotherapy, radiation therapy, investigational drugs including small molecular inhibitors, endocrine therapy, immunotherapy) therapy within 4 weeks prior to the first dose of study treatment or 5 half-lives of the therapy, whichever is shorter.
- Severe cardiovascular disease including symptomatic congestive heart failure (New York Heart Association class III or IV), unstable angina, uncontrolled hypertension, cardiac arrhythmia, a history of myocardial infarction within 6 months or a history of arterial thromboembolic event and pulmonary embolism within 3 months of the first dose of investigational agent, as follows:
- QT/QTc interval prolongation (using Fredericia's QT correction formula) at baseline, Female > 470 ms, Male > 450 ms;
- Medications to prolong the QT/QTc interval are currently being taken;
- Family history of long QT syndrome.
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- Patients with a history of or presently experiencing an active autoimmune disease within 2 years of initiating study drug, or those who are at high risk of relapse ; however, subjects with the following are allowed to enroll:
- Type I diabetes that is stable after a fixed dose of insulin or other hypoglycemic;
- Only requiring hormone replacement therapy for autoimmune hypothyroidism;
- Skin disease that does not require systemic treatment such as eczema rash that accounts for <10% of the body surface, psoriasis without ophthalmic symptoms.
- Subjects who received any major surgery within 4 weeks before the first dose of study treatment (except for diagnostic surgery), and/or subjects who may require major surgery during the study.
- Lung diseases such as, interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, interstitial pneumonia. Patients with well controlled chronic obstructive pulmonary disease (COPD) are allowed.
- Subjects with primary central nervous system (CNS) malignancies, symptomatic CNS metastases, symptomatic parenchymal brain leptomeningeal disease or spinal cord compression, except for the following: who has received prior treatment (surgery/radiotherapy) before signing informed consent form (ICF) and is clinically stable for at least 3 months is allowed (prior treatment with corticosteroids are permitted but must stop 14 days before commencing study treatment）
- Use of any live vaccines within 4 weeks before the first dose of study treatment.
- A history of psychotropic substance abuse who is unable to quit.
- Any patient with an uncontrolled illness such as cardiovascular and cerebrovascular diseases, diabetes, high blood pressure, et, and other severe, acute or chronic medical or psychiatric diseases or laboratory abnormalities that, in the Investigator's opinion, may increase the study-related risks or interfere with the interpretation of the findings.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
Icon Cancer Centre Wesley
Auchenflower, Queensland, 4066
Paul Vasey, +610737374500, Paul.Vasey@icon.team
- Not yet recruiting
Blacktown Hospital
Blacktown, New South Wales, 2148
Rosemary Habib, +61142122770, rosemary.habib@health.nsw.gov.au
- Recruiting
Cabrini Health Limited
Malvern, Victoria, 3144
Prachi Bhave, +611433322012, Prachi_bhave@yahoo.com
About this study
Official title: A Phase I/IIa, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HX044 in Patients with Advanced Solid Tumor Malignancies
The study will consist of a dose-escalation and dose-expansion component to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and to evaluate the preliminary antitumor activity of HX044.
HX044 is an investigational drug that has not yet been approved by the Food and Drug Administration (FDA) or any other regulatory authorities for commercial purposes. This is the first study in which HX044 will be given to humans. The study drug has been tested in animals and was found to be well-tolerated with minimal side effects.
- Conditions
- Advanced Solid Tumor Malignancies
- Being tested
- HX044
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HX044Drug
Conventional dose-escalation design with 3+3 cohort size. All administered on a Q3 weekly basis. Dose escalation will be based on the absence of DLTs during the 21-day DLT evaluation after a review of safety data by the Safety Review Escalation Committee. Subjects will continue on study treatment until the subject develops an intolerable toxicity, withdraws consent, develops progression of disease, death, lost to follow-up, start of new anticancer treatment or up to study treatment duration of 24 months, whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| HX044 | Experimental | Conventional dose-escalation design with 3+3 cohort size. Patients received HX044 treatment at assigned dose level on a Q3 weekly basis. Receives: Drug: HX044 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing Adverse Events (AEs)
An AE is any untoward medical occurence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: All AEs up to 90(±7）days after the last dose of study treatment
Number of Participants With Dose-Limiting Toxicities(DLT) of HX044
All AEs/toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events,Vesion5.0(NCI CTCAE v5.0);For the purpose of dose escalation, any of the following AEs occurring during the DLT observation period that were attributable to one or both study drugs were classified as DLTs.
Measured: At the end of Cycle 2(each cycle is 21±3 days)
Secondary outcomes (6)
Objective response rate (ORR) per Investigator Assessment Using RECIST 1.1 and iRECIST
Objective response rate (ORR) ,using RECIST 1.1 and iRECIST criteria, is defined as the proportion of subjects with best overall response of complete response(CR)/iCR or partial response(PR)/iPR after treatment.
Measured: Approximately 2 years
Disease control rate(DCR) per Investigator Assessment Using RECIST 1.1 and iRECIST
Disease control rate(DCR) ,using RECIST 1.1 and iRECIST criteria, is defined as the proportion of subjects with best overall response of complete response(CR)/iCR or partial response(PR)/iPR or disease stabilization(SD)/iSD after treatment.
Measured: Approximately 2 years
Number of participants with positive Anti-Drug Antibody(ADA) of HX044
ADA blood samples are assayed for anti-HX044 antibodies.
Measured: Cycle 1,2,3,4,5,6,10,14,18 and then every 8 cycles,Day 1: with 60 minutes before the start of the infusion.
Time of Cmax(Tamx) of HX044
Time to reach HX044 maximum observed serum concentration
Measured: Approximately 2 years
Terminal Half life( t½) of HX044
HX044 terminal half-life.
Measured: Approximately 2 years
Area Under the serum concentration-time curve(AUC)
HX044 area under the serum concentration-time curve
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start30 Dec 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumor MalignanciesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanx Biopharmaceuticals (Wuhan) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649708
- Sponsor's protocol ID
- HX044-I-01
- Status last verified
- Jan 2025
- First submitted
- 3 Oct 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HX044 in Patients with Advanced Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT06649708
- Acronym / sponsor ID
- HX044-I-01
- Conditions
- Advanced Solid Tumor Malignancies
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hanx Biopharmaceuticals (Wuhan) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 21 Oct 2024 (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.
The study will consist of a dose-escalation and dose-expansion component to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and to evaluate the preliminary antitumor activity of HX044.
HX044 is an investigational drug that has not yet been approved by the Food and Drug Administration (FDA) or any other regulatory authorities for commercial purposes. This is the first study in which HX044 will be given to humans. The study drug has been tested in animals and was found to be well-tolerated with minimal side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HX044 | Experimental | Drug: HX044Conventional dose-escalation design with 3+3 cohort size. Patients received HX044 treatment at assigned dose level on a Q3 weekly basis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must voluntarily agree to participate by providing written informed consent and agreeing to comply with protocol and scheduled visit;
- Male or female subject aged 18-75 years, inclusive;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- Histologically confirmed advanced malignant solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.
- At least 1 measurable tumor (It is acceptable to allow patients with no measurable lesion but evaluable tumor lesion in the first 2 dose levels in Phase I and at least 1 measurable tumor lesion must be present in Phase IIa) according to RECIST v1.1
Key exclusion criteria (16 listed)
- Prior malignancy active within the previous 5 years except for the tumor for which a subject is enrolled in the study and locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
- Receipt of any anticancer (chemotherapy, radiation therapy, investigational drugs including small molecular inhibitors, endocrine therapy, immunotherapy) therapy within 4 weeks prior to the first dose of study treatment or 5 half-lives of the therapy, whichever is shorter.
- Severe cardiovascular disease including symptomatic congestive heart failure (New York Heart Association class III or IV), unstable angina, uncontrolled hypertension, cardiac arrhythmia, a history of myocardial infarction within 6 months or a history of arterial thromboembolic event and pulmonary embolism within 3 months of the first dose of investigational agent, as follows:
- Patients with a history of or presently experiencing an active autoimmune disease within 2 years of initiating study drug, or those who are at high risk of relapse ; however, subjects with the following are allowed to enroll:
- Subjects who received any major surgery within 4 weeks before the first dose of study treatment (except for diagnostic surgery), and/or subjects who may require major surgery during the study.
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 |
|---|---|---|
| HX044Conventional dose-escalation design with 3+3 cohort size. All administered on a Q3 weekly basis. Dose escalation will be based on the absence of DLTs during the 21-day DLT evaluation after a review of safety data by the Safety Review Escalation Committee. Subjects will continue on study treatment until the subject develops an intolerable toxicity, withdraws consent, develops progression of disease, death, lost to follow-up, start of new anticancer treatment or up to study treatment duration of 24 months, whichever comes first. | Drug | HX044 |
Primary outcome
Number of participants experiencing Adverse Events (AEs)
Time frame: All AEs up to 90(±7）days after the last dose of study treatment
An AE is any untoward medical occurence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Number of Participants With Dose-Limiting Toxicities(DLT) of HX044
Time frame: At the end of Cycle 2(each cycle is 21±3 days)
All AEs/toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events,Vesion5.0(NCI CTCAE v5.0);For the purpose of dose escalation, any of the following AEs occurring during the DLT observation period that were attributable to one or both study drugs were classified as DLTs.
6 secondary outcomes
Objective response rate (ORR) per Investigator Assessment Using RECIST 1.1 and iRECIST
Time frame: Approximately 2 years
Disease control rate(DCR) per Investigator Assessment Using RECIST 1.1 and iRECIST
Time frame: Approximately 2 years
Number of participants with positive Anti-Drug Antibody(ADA) of HX044
Time frame: Cycle 1,2,3,4,5,6,10,14,18 and then every 8 cycles,Day 1: with 60 minutes before the start of the infusion.
Time of Cmax(Tamx) of HX044
Time frame: Approximately 2 years
Terminal Half life( t½) of HX044
Time frame: Approximately 2 years
Area Under the serum concentration-time curve(AUC)
Time frame: Approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HX044 in people with Advanced Solid Tumor Malignancies, run by Hanx Biopharmaceuticals (Wuhan) Co., Ltd. at 3 sites in Australia.
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 11 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuang Liu (+8618601689862, shuang.liu@hanxbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants experiencing Adverse Events (AEs) (time frame: All AEs up to 90(±7）days after the last dose of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025; AzTrials last refreshed its copy on 2 Nov 2026.