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APG-157 + Bevacizumab for Brain Tumor

Phase 1 & 2

Recruiting

Led By Joon Uhm, MD

Research Sponsored by Aveta Biomics, Inc.

Eligibility Criteria Checklist

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

Must have

Patients must have pathologically proven diagnosis of high grade (aka grade III or IV) glioma that has progressed on bevacizumab (anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, gliosarcoma, H3K27M mutant glioma)

Physiologic Status/Age: Patients must be 19 years of age or older (the age of consent in Nebraska)

Must not have

Clinically Significant Cardiovascular Disease Defined as follows: Inadequately controlled hypertension (i.e., systolic blood pressure (SBP) > 160 mm Hg and/or diastolic blood pressure (DBP) > 90 mm Hg despite antihypertensive therapy)

Major surgical procedure, open biopsy, or significant traumatic injury ≤ 28 days prior to registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks; from date of commencement of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a combination of two drugs to see if they can help people with a type of brain tumor live longer and improve their quality of life.

Who is the study for?

This trial is for adults (19+) with high-grade glioma brain tumors that have worsened despite previous treatments including Bevacizumab, radiation, and temozolomide. Participants must be in stable health otherwise, with good organ function and blood counts. Pregnant or nursing women can't join, nor those with recent heart issues or surgeries.

What is being tested?

The study tests APG-157 pastilles taken orally three times daily alongside standard Bevacizumab treatment. It aims to assess the combination's impact on tumor progression, patient survival rates, quality of life, and changes observed in imaging studies.

What are the potential side effects?

While specific side effects of APG-157 aren't listed here, common risks may include mouth sores from dissolving pastilles and typical Bevacizumab-related side effects like hypertension, bleeding problems, wound healing complications, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My high-grade brain tumor has worsened despite bevacizumab treatment.

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I am 19 years old or older.

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My blood tests show enough white cells, hemoglobin, and platelets.

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My kidney function is within the normal range based on creatinine levels.

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I am not pregnant or nursing and agree to use birth control during and 6 months after the study.

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I can care for myself but may not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood pressure is not controlled by medication and is higher than 160/90 mm Hg.

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I have not had major surgery or a significant injury in the last 28 days.

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I have an active or non-healing wound, ulcer, or untreated bone fracture.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 8 weeks; from date of commencement of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 8 weeks; from date of commencement of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks; from date of commencement of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Progression-free Survival

Secondary study objectives

Pharmacokinetics (PK) of APG-157

QOL assessment (EORTC QLQ-C30)

Radiographic studies MRI or CT of the brain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: APG-157Experimental Treatment1 Intervention

The participants will receive APG-157 daily by taking two pastilles in their mouth at around breakfast, lunch and dinner time (total of six pastilles per day). The pastilles dissolve in the mouth. The participants will continue to receive Bevacizumab as standard of care.

0 / 9Eligibility criteria met