GliomaPhase 1/2NCT06703255
A Phase 2 Study of HX301 in Patients with High-grade Giloma
A Phase 1/2 study testing HX301+/Temozolomide in people with Glioma, run by Hangzhou Hanx Biopharmaceuticals, Ltd. at 1 site in China.
Trial summary
The study will include a dose-escalation and dose-expansion component to establish the recommended Phase 2 dose (RP2D) for HX301 in combination with Temozolomide and to evaluate the preliminary antitumor activity of HX301.HX301 is an investigational drug that has not yet been approved by the Food and Drug… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- HX301+/Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2025to 31 Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form;
- Age ≥ 18 years;
- Expected survival ≥ 12 weeks;
- Part I:1) Histologically confirmed high-grade glioma (WHO classification grade III or IV); 2) At least one prior temozolomide treatment; 3) Patients with recurrent or progressive clinically assessed disease according to RANO criteria with evaluable lesions; Part II: Patients with histological or cytological diagnosis of glioblastoma according to World Health Organization (WHO) classification (2021) who received surgical treatment for the first time and standard concurrent chemoradiotherapy and who have not received any other prior treatment;
- Part II: Subjects must undergo partial or complete surgical resection, and available results of postoperative brain contrast-enhanced MRI were documented as follows: 1) complete resection without gadolinium enhancement ; or 2) complete resection (80% or more);
- Part II: Subjects must complete initial radiotherapy combined with TMZ (concurrent chemoradiotherapy) for glioblastoma according to the Stupp regimen (Stupp 2005) (total radiation dose 5 4-60 G y);
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- Part I: If radiotherapy has been performed, the completion of radiotherapy shall last for 3 months, or there shall be tumor progression or histopathological confirmation of progression in the original radiation field within 3 months; Part II: there shall be no evidence of disease progression after chemoradiotherapy, except for pseudo progression;
- Dexamethasone was administered at ≤ 5 mg/day at study entry.Corticosteroids should be reduced as far as possible to the smallest dose necessary to control neurological symptoms before receiving study treatment;
- Karnofsky performance status (KPS) ≥ 70 within 1 4days prior to receiving study treatment ;
- Willing and able to comply with the protocol.
Who cannot join
- Part II: Patients with recurrent glioblastoma;
- Distant metastasis involving brainstem and meninges or extension of lesions to spinal cord;
- Human immunodeficiency virus (HIV) antibody positive, syphilis antibody (Anti-TP) positive, hepatitis C virus (HCV) antibody positive and HCV RNA positive, hepatitis B virus surface antigen (HBsAg) positive and HBV DNA positive (HBsAg positive requires further detection of HBV DNA, HBV DNA ≥ 200 IU/ml, or ≥ 10 3 copies/ml);
- Hypersensitivity to temozolomide and/or components of HX301;
- At risk for torsades de pointes (TdP): patients with a marked prolongation of the QT/QTc interval calculated using the Fredericia QT correction formula at baseline (eg, repeated demonstration of QTc interval > 470 ms), or a history of other TdP risk factors (eg, heart failure, hypokalemia, family history of long QT syndrome), or patients who are currently taking medications that prolong the QT/QTc interval;
- Grade ≥ 2 diarrhea at baseline;
- Participation in another study involving an investigational drug within 30 days prior to the first dose of study drug;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, 100083
Wenbin Li, 86+15301377998, Neure55@126.com
About this study
Official title: A Phase IIa Clinical Study of HX301 Alone or in Combination with Temozolomide in Patients with High-Grade Glioma (Grade III and IV)
The study will include a dose-escalation and dose-expansion component to establish the recommended Phase 2 dose (RP2D) for HX301 in combination with Temozolomide and to evaluate the preliminary antitumor activity of HX301.HX301 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.
- Conditions
- Glioma
- Being tested
- HX301+/Temozolomide
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HX301+/TemozolomideDrug
Part I: It is planned to firstly explore a dose of 160 mg and enroll approximately 3-6 subjects to receive HX301 monotherapy until disease progression, intolerable toxicity, or other reasons for stopping treatment for up to 24 cycles of 28 days each. Safety evaluation was performed using the traditional "3 + 3" rule, and the DLT observation period was 28 days (C1D1 ~ C1D28). If 160 mg was not tolerated, it was reduced to 120 mg for exploration. Part II: Combination therapy phase: HX301 will be administered in combination with temozolomide approximately 4-6 weeks after completion of chemoradiotherapy. The TMZ dose will follow the first cycle: 150 mg/m 2 qd D1-D5, starting with the second cycle, and if the criteria for TMZ dose increase are met, TMZ will be administered as 200 mg/m 2 qd D1-D5 every 2 8 days for up to 12 cycles. Monotherapy maintain period: Following the end of temozolomide treatment, HX301 monotherapy will be continued for a maximum of 12 cycles of 28 days each.
| Study group | Role | What they receive |
|---|---|---|
| Patients received HX301/+Temozolomide treatment at assigned dose level on a 4 weeks basis | Experimental | Not described Receives: Drug: HX301+/Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part I: 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 28(±7)days after the last dose of study treatment
Part I: Identify the recommended phase IIa dose (RP2D) of HX301 in patients with high-grade glioma;
RP2D is Recommended Phase II Dose.
Measured: 24 Cycles of 28 days each.
Part II (HX301 monotherapy safety run-in period) : 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 28(±7)days after the last dose of study treatment
Part II (HX301 monotherapy safety run-in period) : Identify the recommended phase IIa dose (RP2D) of HX301 combination with TMZ in patients with high-grade glioma;
RP2D is Recommended Phase II Dose.
Measured: 24 Cycles of 28 days each.
Part II (HX301 in combination with temozolomide) : Progression-free survival（PFS） per Investigator assessed using RANO criteria.
Measured: 24 Cycles of 28 days each.
Part II (HX301 in combination with temozolomide) :Objective response rate（ORR） per Investigator assessed using RANO criteria.
Measured: 24 Cycles of 28 days each.
Secondary outcomes (3)
Part I : Objective response rate（ORR） per Investigator assessed using RANO criteria.
Measured: 24 Cycles of 28 days each.
Part II (HX301 monotherapy safety run-in period) : Objective response rate（ORR） per Investigator assessed using RANO criteria.
Measured: 24 Cycles of 28 days each.
Part II (HX301 in combination with temozolomide) :Overall survival（OS） per Investigator assessed using RANO criteria.
Measured: 24 Cycles of 28 days each.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start8 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Hanx Biopharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703255
- Sponsor's protocol ID
- HX301-II-01
- Status last verified
- Jan 2025
- First submitted
- 21 Nov 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Clinical Study of HX301 Alone or in Combination with Temozolomide in Patients with High-Grade Glioma (Grade III and IV)
- ClinicalTrials.gov ID
- NCT06703255
- Acronym / sponsor ID
- HX301-II-01
- Conditions
- Glioma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hangzhou Hanx Biopharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Nov 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 include a dose-escalation and dose-expansion component to establish the recommended Phase 2 dose (RP2D) for HX301 in combination with Temozolomide and to evaluate the preliminary antitumor activity of HX301.HX301 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients received HX301/+Temozolomide treatment at assigned dose level on a 4 weeks basis | Experimental | Drug: HX301+/Temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent form;
- Age ≥ 18 years;
- Expected survival ≥ 12 weeks;
- Part I:1) Histologically confirmed high-grade glioma (WHO classification grade III or IV); 2) At least one prior temozolomide treatment; 3) Patients with recurrent or progressive clinically assessed disease according to RANO criteria with evaluable lesions; Part II: Patients with histological or cytological diagnosis of glioblastoma according to World Health Organization (WHO) classification (2021) who received surgical treatment for the first time and standard concurrent chemoradiotherapy and who have not received any other prior treatment;
- Part II: Subjects must undergo partial or complete surgical resection, and available results of postoperative brain contrast-enhanced MRI were documented as follows: 1) complete resection without gadolinium enhancement ; or 2) complete resection (80% or more);
Key exclusion criteria (7 listed)
- Part II: Patients with recurrent glioblastoma;
- Distant metastasis involving brainstem and meninges or extension of lesions to spinal cord;
- Human immunodeficiency virus (HIV) antibody positive, syphilis antibody (Anti-TP) positive, hepatitis C virus (HCV) antibody positive and HCV RNA positive, hepatitis B virus surface antigen (HBsAg) positive and HBV DNA positive (HBsAg positive requires further detection of HBV DNA, HBV DNA ≥ 200 IU/ml, or ≥ 10 3 copies/ml);
- Hypersensitivity to temozolomide and/or components of HX301;
- At risk for torsades de pointes (TdP): patients with a marked prolongation of the QT/QTc interval calculated using the Fredericia QT correction formula at baseline (eg, repeated demonstration of QTc interval > 470 ms), or a history of other TdP risk factors (eg, heart failure, hypokalemia, family history of long QT syndrome), or patients who are currently taking medications that prolong the QT/QTc interval;
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 |
|---|---|---|
| HX301+/TemozolomidePart I: It is planned to firstly explore a dose of 160 mg and enroll approximately 3-6 subjects to receive HX301 monotherapy until disease progression, intolerable toxicity, or other reasons for stopping treatment for up to 24 cycles of 28 days each. Safety evaluation was performed using the traditional "3 + 3" rule, and the DLT observation period was 28 days (C1D1 ~ C1D28). If 160 mg was not tolerated, it was reduced to 120 mg for exploration. Part II: Combination therapy phase: HX301 will be administered in combination with temozolomide approximately 4-6 weeks after completion of chemoradiotherapy. The TMZ dose will follow the first cycle: 150 mg/m 2 qd D1-D5, starting with the second cycle, and if the criteria for TMZ dose increase are met, TMZ will be administered as 200 mg/m 2 qd D1-D5 every 2 8 days for up to 12 cycles. Monotherapy maintain period: Following the end of temozolomide treatment, HX301 monotherapy will be continued for a maximum of 12 cycles of 28 days each. | Drug | Patients received HX301/+Temozolomide treatment at assigned dose level on a 4 weeks basis |
Primary outcome
Part I: Number of participants experiencing Adverse Events (AEs)
Time frame: All AEs up to 28(±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.
Part I: Identify the recommended phase IIa dose (RP2D) of HX301 in patients with high-grade glioma;
Time frame: 24 Cycles of 28 days each.
RP2D is Recommended Phase II Dose.
Part II (HX301 monotherapy safety run-in period) : Number of participants experiencing Adverse Events (AEs)
Time frame: All AEs up to 28(±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.
Part II (HX301 monotherapy safety run-in period) : Identify the recommended phase IIa dose (RP2D) of HX301 combination with TMZ in patients with high-grade glioma;
Time frame: 24 Cycles of 28 days each.
RP2D is Recommended Phase II Dose.
Part II (HX301 in combination with temozolomide) : Progression-free survival（PFS） per Investigator assessed using RANO criteria.
Time frame: 24 Cycles of 28 days each.
Part II (HX301 in combination with temozolomide) :Objective response rate（ORR） per Investigator assessed using RANO criteria.
Time frame: 24 Cycles of 28 days each.
3 secondary outcomes
Part I : Objective response rate（ORR） per Investigator assessed using RANO criteria.
Time frame: 24 Cycles of 28 days each.
Part II (HX301 monotherapy safety run-in period) : Objective response rate（ORR） per Investigator assessed using RANO criteria.
Time frame: 24 Cycles of 28 days each.
Part II (HX301 in combination with temozolomide) :Overall survival（OS） per Investigator assessed using RANO criteria.
Time frame: 24 Cycles of 28 days each.
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 15 Jan 2025.
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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.
1 site 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 HX301+/Temozolomide in people with Glioma, run by Hangzhou Hanx Biopharmaceuticals, 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 10 inclusion and 7 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 15 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 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 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?
Part I: Number of participants experiencing Adverse Events (AEs) (time frame: All AEs up to 28(±7)days after the last dose of study treatment). 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 15 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.