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Small Molecule Inhibitor

Safusidenib for Brain Cancer

Phase 2

Recruiting

Research Sponsored by AnHeart Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has received no more than 2 prior therapies for disease recurrence/progression.

Patient must be ≥ 18 years of age at the time of signing the informed consent form (ICF).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from drug treatment to 2 years

Awards & highlights

Study Summary

This trial studies the efficacy, safety, & PK of an experimental drug to treat recurrent/progressive IDH1 mutant glioma (brain cancer). It will enroll up to 60 patients in 2 parts & an exploratory surgery cohort.

Who is the study for?

Adults over 18 with recurrent or progressive brain tumors (WHO Grade 2/3 glioma) and specific IDH1 mutations can join this trial. They must have had no more than two prior treatments, a measurable lesion, good organ function, and a life expectancy of at least three months. Women must not be able to bear children or use contraception; men should use condoms.Check my eligibility

What is being tested?

The study tests different doses of safusidenib, an oral drug for brain tumors with IDH1 mutation. Part 1 assesses safety and initial efficacy in up to 25 patients across five dosage groups. Part 2 evaluates the drug's effectiveness in larger cohorts for each tumor grade.See study design

What are the potential side effects?

Specific side effects are not listed here but may include typical reactions to cancer drugs such as nausea, fatigue, liver issues, blood count changes, and potential allergic reactions based on similar medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had 2 or fewer treatments for my cancer coming back or getting worse.

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I am 18 years or older and can sign the consent form.

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My brain tumor is a Grade 2 or 3 glioma with a specific IDH1 mutation.

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My cancer has an IDH mutation confirmed by a certified lab test.

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My cancer has come back or gotten worse, or I can't handle my current treatment.

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I have a tumor that can be measured by specific medical criteria.

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I can care for myself but may need occasional assistance.

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My kidneys are functioning well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from drug treatment to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from drug treatment to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from drug treatment to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

part1: Incidence of adverse events (AEs) and serious adverse events (SAEs)

part2: ORR by the IRC

Secondary outcome measures

Part 1 Stage 1: AUC12h of safusidenib

Part 1 Stage 1: AUC24h [QD only] of safusidenib

Part 1 Stage 1: AUC8h of safusidenib

+21 more

Other outcome measures

for part 1 stage 2 surgical participants: 2-hydroxyglutarate (2-HG) concentrations in the tumor tissue

for part 1 stage 2 surgical participants: Safusidenib concentrations in both plasma and tumor tissues

Trial Design

5Treatment groups

Experimental Treatment

Group I: safusidenib 500mg qdExperimental Treatment1 Intervention

safusidenib 500mg qd administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.

Group II: safusidenib 500mg bidExperimental Treatment1 Intervention

safusidenib 500mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.

Group III: safusidenib 375mg bidExperimental Treatment1 Intervention

safusidenib 375mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.

Group IV: safusidenib 250mg bidExperimental Treatment1 Intervention

safusidenib 250mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.

Group V: safusidenib 125mg bidExperimental Treatment1 Intervention

safusidenib 125mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

AnHeart Therapeutics Inc.Lead Sponsor

10 Previous Clinical Trials

713 Total Patients Enrolled

Media Library

AB-218 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05303519 — Phase 2

Brain Tumor Research Study Groups: safusidenib 500mg bid, safusidenib 125mg bid, safusidenib 250mg bid, safusidenib 500mg qd, safusidenib 375mg bid

Brain Tumor Clinical Trial 2023: AB-218 Highlights & Side Effects. Trial Name: NCT05303519 — Phase 2

AB-218 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05303519 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research still open to participants?

"According to the online database, clinicaltrials.gov this study is actively enrolling participants. The trial was first advertised on May 26th 2023 and had most recently been updated two days prior, on May 23rd 2023."

Answered by AI

Has the Food and Drug Administration sanctioned safusidenib 125mg bid as a viable treatment?

"The safety of safusidenib 125mg bid was judged a 2 on the 1-3 risk scale, since there is proof of its security but no data to back up its effectiveness."

Answered by AI

Approximately how many individuals have joined the clinical trial thus far?

"That is accurate. According to clinicaltrials.gov, this medical trial has been actively seeking participants since May 26th 2023 and was recently updated on the 23rd of that same month. The study requires 95 people from one location for further evaluation."

Answered by AI

What is the purported outcome of this medical experiment?

"This clinical trial's primary outcome, spanning from the time of participant enrollment to 30 days after final dose administration, will be evaluated by an Independent Response Committee (IRC) in terms of Objective Response Rate. Secondary outcomes encompass Safusidenib Maximum Concentration (Tmax), 8-hour Area Under the Plasma Concentration Curve (AUC8h) and 12-hour Area Under the Plasma Concentration Curve (AUC12h)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safusidenib Phase 2 Study in IDH1 Mutant Glioma

2023. "Safusidenib Phase 2 Study in IDH1 Mutant Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05303519.

All > Glioma