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A Phase 2 Study of HX301 in Patients with High-grade Giloma

ConditionGlioma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou Hanx Biopharmaceuticals, Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • HX301+/Temozolomide

    Drug

    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.

Treatment groups

72 Participants
are divided into 1 treatment group
Group A: Patients received HX301/+Temozolomide treatment at assigned dose level on a 4 weeks basisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
All AEs up to 28(±7)days after the last dose of study treatment
2

Part I: Identify the recommended phase IIa dose (RP2D) of HX301 in patients with high-grade glioma;

RP2D is Recommended Phase II Dose.

Time frame
24 Cycles of 28 days each.
3

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.

Time frame
All AEs up to 28(±7)days after the last dose of study treatment
4

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.

Time frame
24 Cycles of 28 days each.

Secondary outcomes

1

Part I : Objective response rate（ORR） per Investigator assessed using RANO criteria.

Time frame
24 Cycles of 28 days each.
2

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.
3

Part II (HX301 in combination with temozolomide) :Overall survival（OS） per Investigator assessed using RANO criteria.

Time frame
24 Cycles of 28 days each.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hangzhou Hanx Biopharmaceuticals, Ltd.

Lead sponsor

Source ClinicalTrials.gov
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