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A Phase II Study of SYHA1813 for Recurrent or Progressive High-Grade Meningioma

ConditionRecurrent or Progressive High Grade Meningioma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Runshi Pharmaceutical Technology Co., Ltd

About this trial

This is a randomized, controlled, open-label, multicenter, Phase II clinical study designed to evaluate the efficacy and safety of SYHA1813 compared to investigators' choice in participants with recurrent or progressive high-grade meningioma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged >= 18 years;

Histologically confirmed WHO grade II/III meningioma (WHO CNS 5th)

There is at least one measurable lesion in the baseline period (RANO-meningioma);

KPS≥60;

Disqualifiers

Patients who are known or suspected to be allergic to the test drug or its components;

Meets one of the following conditions: patients with brainstem involvement; patients with severe brain herniation or at risk of brain herniation; patients with extracranial metastasis during the screening period.

A history of any other malignant tumors within 3 years (except for effectively controlled skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer or cured carcinoma in situ);

Use of glucocorticoids at an equivalent dose exceeding 5mg of dexamethasone within 7 days prior to randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SYHA1813

    Drug

    The starting dose of SYHA1813 is 20mg QD

  • Investigator's Choice Treatment

    Drug

    Investigator's Choice Treatment

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

the Progression-free survival (PFS) at 6-month（PFS-6）as evaluated by investigator (RANO-meningioma)

Time frame
Up to approximately 3years

Secondary outcomes

1

Progression-free survival (PFS) as evaluated by INV (RANO-meningioma)

Time frame
Up to approximately 3years
2

Objective response rate (ORR) as evaluated by INV (RANO-meningioma)

Time frame
Up to approximately 3years
3

Disease control rate (DCR) as evaluated by INV (RANO-meningioma)

Time frame
Up to approximately 3years
4

Overall survival (OS)

Time frame
Up to approximately 3years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Shanghai Runshi Pharmaceutical Technology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: