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

NCT06739213 | Not Yet Recruiting Phase 2

• 1 other identifier: SYHA1814-004
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Recurrent or Progressive High Grade Meningioma

Outcome Measures

Primary Outcomes (1)

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

  Up to approximately 3years

Secondary Outcomes (9)

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

  Up to approximately 3years

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

  Up to approximately 3years

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

  Up to approximately 3years

• Overall survival (OS)

  Up to approximately 3years

• Frequency and severity of TEAE and SAE

  Up to approximately 3years

Study Arms (2)

Experimental group

EXPERIMENTAL

SYHA1813

Drug: SYHA1813

Control group

ACTIVE COMPARATOR

Investigator's Choice Treatment

Drug: Investigator's Choice Treatment

Interventions

SYHA1813 DRUG

The starting dose of SYHA1813 is 20mg QD

Experimental group

Investigator's Choice Treatment DRUG

Investigator's Choice Treatment

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• The expected survival time is \>=3 months;
• The organ function level and related laboratory indicators must meet requirements (no blood transfusion within 2 weeks):
• Female participants of childbearing potential must have a negative the blood pregnancy test results of within 7 days prior to randomization and agree to use reliable and effective contraception during the study treatment period and for at least 3 months after the last study treatment (or as required by the drug's instructions). Male participants with partners of childbearing potential must agree to use reliable and effective contraception during the study treatment period and for at least 3 months after the last study treatment (or as required by the drug's instructions).

You may not qualify if:

• 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.
• The toxicity of previous anti-tumor treatments has not recovered to Grade1(including brain edema after radiotherapy), with the exception of hair loss, uncomplicated laboratory abnormalities that do not require medical intervention, and other adverse reactions deemed by the investigator not to affect the safety of the study medication.;
• Use of a strong CYP3A4 inhibitor within 14 days prior to randomization or ongoing use of such inhibitors.
• Current use of warfarin or other oral anticoagulants (except for low-dose anticoagulants used to maintain central venous access or prevent deep vein thrombosis).
• Inability to undergo contrast-enhanced MRI
• Patients with evidence of bleeding tendency or medical history within 2 moths
• Urine protein ≥ 2+, and 24-hour urine protein quantitative ≥ 1.0g/24h;
• Human immunodeficiency virus (HIV) antibody positive; active hepatitis C (anti-HCV antibody positive and HCV RNA test positive); active hepatitis B (HBV DNA test for HBsAg is positive and HBV DNA is equal to or higher than 2×10\^3 IU/ml));
• The subject has poorly healed wounds, ulcers or fractures;
• Presence of a severe chronic or active infection (including tuberculosis and other infections).requiring intravenous antibiotic, antifungal, or antiviral treatment within 14 days prior to randomization
• Other severe systemic diseases, including but not limited to uncontrolled diabetes, kidney disease requiring dialysis, severe liver disease (Child-Pugh class B or C), acute pancreatitis, etc.
• Subjects with clinically significant cardiovascular and cerebrovascular diseases.

Sponsors & Collaborators

• Shanghai Runshi Pharmaceutical Technology Co., Ltd: lead

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, controlled, open-label, multicenter, Phase II clinical trail, randomized 1:1 to receive either SYHA1813 (experimental group) or investigators' choice (control group).

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 18, 2024
• Study Start: January 31, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 13, 2028
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share