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OncoMatch/Clinical Trials/NCT06703255

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

Is NCT06703255 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies HX301+/Temozolomide for glioma.

Phase 1/2RecruitingHangzhou Hanx Biopharmaceuticals, Ltd.NCT06703255Data as of May 2026

Treatment: HX301+/TemozolomideThe 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.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Disease stage

Required: Stage GRADE III, GRADE IV (WHO)

Grade: IIIIV (WHO)

WHO classification grade III or IV

Prior therapy

Must have received: alkylating agent (temozolomide) — Part I: at least one prior temozolomide treatment

Part I: ... At least one prior temozolomide treatment

Must have received: radiation therapy — Part II: standard concurrent chemoradiotherapy (Stupp regimen)

Part II: ... standard concurrent chemoradiotherapy ... according to the Stupp regimen

Cannot have received:

Participation in another study involving an investigational drug within 30 days prior to the first dose of study drug

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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