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HMPL-306 in Participants With Postoperative Residual or Recurrent Grade 2 Glioma Harboring IDH1 or IDH2 Mutations

27 octobre 2026 mis à jour par: Hutchmed

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HMPL-306 in Participants With Postoperative Residual or Recurrent Grade 2 Glioma Harboring IDH1 or IDH2 Mutations

This study is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial evaluating the efficacy and safety of HMPL-306 in participants with postoperative residual or recurrent grade 2 gliomas carrying IDH1 or IDH2 mutations.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

This study plans to enroll approximately 210 participants with postoperative residual or recurrent grade 2 astrocytoma or oligodendroglioma carrying IDH1 or IDH2 mutations who have previously received only surgical treatment.

Participants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 250 mg or placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.

Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment.

Type d'étude

Interventionnel

Inscription (Estimé)

210

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Lu Chen
  • Numéro de téléphone: 021 -2067 3000 - 5014
  • E-mail: Luc@hutch-med.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Have fully understood this study and voluntarily signed the ICF, willing to complete the planned visits, treatments, procedures, and laboratory tests during the study period;
  2. Age ≥18 years old;
  3. Patients with grade 2 oligodendroglioma or grade 2 astrocytoma;
  4. Have confirmed presence of IDH1 or IDH2 gene mutation, and obtained chromosome 1p/19q status;
  5. Have undergone at least 1 glioma surgery and have not received any other anti-glioma treatments, including chemotherapy and radiotherapy;
  6. Confirmed by BIRC, at least 1 measurable non-enhancing lesion meeting RANO 2.0 criteria using two-dimensional magnetic resonance imaging (MRI) measurement at screening;
  7. KPS ≥80;
  8. As judged by the investigator, life expectancy of ≥12 months;
  9. Adequate bone marrow, hepatic, renal, and coagulation function

Exclusion Criteria:

  1. Previously received any other anti-glioma treatment except for surgery, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, or biological therapy, etc.;
  2. Participants assessed by the investigator as having high-risk factors, including but not limited to tumor involvement of the brainstem, or uncontrolled epilepsy;
  3. Participants with concurrent other malignant tumors or a history of other malignant tumors within 5 years prior to randomization (excluding cured basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast, etc.);
  4. Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
  5. Known allergy to any component of HMPL-306;
  6. Administration of uridine diphosphate glucuronosyltransferase (UGT) 1A1 inhibitors or UGT1A3 inhibitors less than 1 week or 5 half-lives (whichever is longer) prior to randomization; administration of strong inducers of CYP3A less than 2 weeks or 5 half-lives (whichever is longer) prior to randomization;
  7. Presence of diseases or conditions that affect drug absorption;
  8. Participants will be excluded if there is any other disease, mental abnormality, metabolic abnormality, physical examination abnormality, or laboratory parameter abnormality of significant clinical significance, etc., which, in the investigator's judgment, may affect the participant's compliance, or place the participant at high risk, or affect the interpretation of study results, or if there is reason to suspect that the participant has a disease or condition unsuitable for the use of the study drug.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: HMPL-306 tablet

Participants in HMPL-306 group will receive HMPL-306 250 mg administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.
Médicament: HMPL-306 tablet

Participants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 or placebo matched to HMPL-306 administered orally once daily (QD). Participants in HMPL-306 group will receive HMPL-306 250 mg administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.
Comparateur placebo: Placebo

Participants in placebo group will receive placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.

Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment.
Médicament: Placebo

Participants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 or placebo matched to HMPL-306 administered orally once daily (QD). Participants in placebo group will receive placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.

Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
PFS assessed by BIRC (according to Response Assessment in Neuro-Oncology [RANO] 2.0 criteria)
Délai: Up to approximately 30 months

PFS(progression-free survival ):The time from the date of randomization to the date of first disease progression (PD) confirmed by BIRC(Blinded Independent Review Committee) or death from any cause
Up to approximately 30 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
TTNI
Délai: Up to approximately 36 months

TTNI(time to next intervention ):The time from the date of randomization to the date of first initiation of any subsequent anti-tumor therapy or all-cause death
Up to approximately 36 months
TGR
Délai: every 6months,up to approximately 30 months

TGR( tumor growth rate) :The time from the date of randomization to the date of first disease progression (PD) confirmed by BIRC or death from any cause
every 6months,up to approximately 30 months
TEAEs
Délai: Up to approximately 30 months

Treatment-emergent adverse events (TEAEs) are defined as all adverse medical events that occur after participants receive the investigational medicinal product, which may manifest as symptoms, signs, diseases, or laboratory abnormalities, but are not necessarily causally related to the investigational medicinal product.
Up to approximately 30 months
PFS assessed by Investigator
Délai: Up to approximately 30 months

PFS ( progression-free survival) : the time from the date of randomization to the date of first PD confirmed by investigators or all-cause death
Up to approximately 30 months
ORR
Délai: Up to approximately 30 months

ORR(objective response rate),defined as the proportion of participants with best overall response of complete response (CR), partial response (PR), and minor response (MR)
Up to approximately 30 months
DCR
Délai: Up to approximately 30 months

DCR(disease control rate), defined as the proportion of participants with best overall response of CR(complete response), PR(partial response), MR(minor response), and SD(Stable Disease )
Up to approximately 30 months
TTR
Délai: Up to approximately 30 months

TTR(the time to response), defined as the time from the date of randomization to the date of first documented CR(complete response), PR(partial response), MR(minor response)
Up to approximately 30 months
DoR
Délai: Up to approximately 30 months

DoR( duration of response), defined as the time from the date of first documented CR(complete response), PR(partial response), MR(minor response) to the date of first documented PD(Disease Progression) or death
Up to approximately 30 months
(CR+PR) Rate
Délai: Up to approximately 30 months

CR+PR rate(the proportion of complete response and partial response), defined as the proportion of participants with best overall response of CR(complete response), and PR(partial response)
Up to approximately 30 months
Time to CR+PR
Délai: Up to approximately 30 months

Time to CR+PR, defined as the time from the date of randomization to the date of first documented CR(complete response), or PR(partial response)
Up to approximately 30 months
Duration of CR+PR
Délai: Up to approximately 30 months

Duration of CR+PR, defined as the time from the date of first documented CR or PR to the date of first documented PD or death from any cause, whichever occurs first
Up to approximately 30 months
OS
Délai: Up to approximately 30 months

Overall survival (OS) :the time from the date of randomization to the date of all-cause death
Up to approximately 30 months
HRQoL (health-related quality of life)assessed by the FACT-Br (Functional Assessment of Cancer Therapy-Brain)questionnaire
Délai: Up to approximately 30 months

The health-related quality of life (HRQoL) will be evaluated using the Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire in participants treated with HMPL-306 versus placebo
Up to approximately 30 months
PK characteristics(plasma drug concentrations at each sampling time point)
Délai: Up to approximately 6 months

Plasma drug concentrations at each sampling time point
Up to approximately 6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hutchmed

Les enquêteurs

  • Chercheur principal: Jinsong Wu, MD, Huashan Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 novembre 2026

Achèvement primaire (Estimé)

1 mars 2032

Achèvement de l'étude (Estimé)

1 septembre 2032

Dates d'inscription aux études

Première soumission

19 octobre 2026

Première soumission répondant aux critères de contrôle qualité

27 octobre 2026

Première publication (Réel)

3 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 2026-306-00CH1

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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