Aperçu

Éligibilité

Détails de la conception

Bras et interventions

Mesures des résultats

Sites d'essai

Source : NCT05533463

Statut inconnu

Phase I Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation

Interventionnel

Phase 1

Shanghai Pulmonary Hospital

Sponsor: Jiangsu HengRui Medicine

Dernière synchronisation : 7 novembre 2023
Avis - Les informations proviennent de registres publics et peuvent ne pas refléter les changements en temps réel sur le site local.

The study is being conducted to evaluate the safety and tolerability of HRS-4642 in patients with advanced solid tumors harboring KRAS G12D mutation.To estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg, recommended phase 2 dose [RP2D]) within investigated subject population groups

Catégorie de traitement

Autres médicaments

Mutations requises

RAS, KRAS, HRAS, NRAS

Essai commencé

15 septembre 2022

Dernière mise à jour par le sponsor

7 novembre 2023

Achèvement estimé

30 avril 2024

Contact de l'étude

Nom:Wei Shi

E-mail:Wei.shi@hengrui.com

Téléphone:+021-61053363

Éligibilité

Critères d'inclusion

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

2. Male or female ≥ 18 years old.

3. Histologically confirmed diagnosis of advanced solid tumor harbouring with KRAS G12D mutation

4. ECOG performance status of 0-1.

5. With a life expectancy of ≥3 months.

6. Have at least one measurable lesion.

7. Adequate laboratory parameters during the screening period

Critères d'exclusion

1. Previously received KRAS G12D inhibitors

2. Priot radiotherapy within 28 days for non-thoracic radiation

3. Prior anti-tumor chemotherapy (< 6 weeks if chemotherapy including nitrosoureas or mitomycin) within 4 weeks before the study drug administration

4. Any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or inclusion/exclusion criteria level (The investigators determined that safe and controllable toxicity was excluded, such as alopecia and ≤ grade 2 peripheral neuropathy ).

5. Central nervous system (CNS) metastases

6. Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study.

7. Known history of hypersensitivity to any components of HRS-4642.

8. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.

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Détails de la conception

AllocationN/A

Modèle d'interventionSingle Group Assignment

MasquageNone (Open Label)

Nombre à inscrire108

Bras et interventions

Bras

Interventions

Type : Experimental

Description : In Dose Escalation: HRS-4642 will be injected QW. Six dose levels are preset. In Dose Expansion: 1 to 2 dose cohorts will be selected for dose expansion stage. In Indication Expansion: Enrollment into the dose expansion cohorts may be from any eligible solid tumor type.

Interventions :

HRS-4642

Mesures des résultats

Mesures des résultats primaires

Safety endpoints: adverse events(AEs), serious adverse events（SAEs）.24 months

Assess safety and tolerability of HRS-4642 by way of adverse events (CTCAE v5.0).

Dose Limited Toxicity(DLT)from day 1 to Day 21

A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 Day 1 (C1D1), excluding toxicities clearly related to disease progression or intercurrent illness

Maximum tolerated dose (MTD)From Day 1 to Day 21

Incidence and category of dose limiting toxicities (DLTs) during the first 21-day cycle of HRS-4642 treatment.

RP2D24 months

RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in dose escalation and dose expansion stages.

Mesures des résultats secondaires

Number of Participants With Abnormal Laboratory Values24months.

Number of subjects with clinically significant changes in ECOG, vital signs and physical examination.24months.

Number of subjects with changes on ECG.24months.

Efficacy endpoints: Overall response rate (ORR).24months.

Evaluated by RECIST v1.1.

Efficacy endpoints: Duration of response (DoR).24 months.

Evaluated by RECIST v1.1

Efficacy endpoints: Disease control rate (DCR).24months.

Evaluated by RECIST v1.1.

Efficacy endpoints: Progression free survival (DoR).24months.

Evaluated by RECIST v1.1.

Efficacy endpoints: overall survival (OS).24minths

Evaluated by RECIST v1.1

Cmax.24 months.

Maximal plasma concentration.

Tmax.24 months

Time to Cmax.

AUC.24 months.

Area under the plasma concentration-time curve.

t1/2.24 months.

Terminal-phase elimination half-life.

Vz/F.24 months.

Apparent volume of distribution during terminal phase after non-intravenous administration.

CL/F.24 months.

Apparent total clearance of the drug from plasma after oral administration.

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Sites d'essai

Cette étude compte 1 site d'essai

Shanghai Pulmonary Hospital

ShangHai, Shanghai, CN

Nom:Caicun Zhou

Recrutement en cours

ShangHai, Shanghai, 200433 CN

Shanghai Pulmonary Hospital

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