GlioblastomaNCT05551013
Treatment of Recurrent GBM With APG-157 Via Expanded Access
A study testing APG-157 in people with Glioblastoma and Glioblastoma Multiforme, run by Aveta Biomics, Inc..
Trial summary
This expanded access request will evaluate APG-157, a botanical drug under development for other cancers, as potential treatment for recurrent Glioblastoma multiforme (GBM) patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glioblastoma, Glioblastoma Multiforme
- What is being tested?
- APG-157
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Who may be able to join
- This study will enroll patients with histologically confirmed glioblastoma (GBM).
- Patients must have received prior treatment with standard first-line therapy for GBM, including maximal surgical resection and postoperative external-beam radiotherapy or Tumor Treating Fields (Optune). Concurrent chemoradiation with TMZ or Tumor Treating Field (Optune) is allowed but not mandatory.
- Patients are eligible for enrollment only if they have unequivocal evidence of tumor recurrence/progression by MRI a minimum of 12 weeks following completion of radiation therapy or TMZ-Radiotherapy or Optune. Patients who have received prior bevacizumab or other anti-vascular endothelial growth factor(anti-VEGF) agents are not eligible to enroll.
- Baseline MRI should be performed within 28 days prior to enrollment.
- Other key inclusion criteria include Eastern Cooperative Oncology Group (ECOG) status of 0-1 (KPS ≥ 70%) and adequate bone marrow, hepatic, and renal function at baseline.
Who cannot join
- Patients with severe neutropenia
About this study
This expanded access request will evaluate APG-157, a botanical drug under development for other cancers, as potential treatment for recurrent Glioblastoma multiforme (GBM) patients.
Read the detailed description
Glioblastoma patients with disease recurrence after primary, currently approved primary treatments have limited options. Therefore, this expanded access trial is designed to test a new therapeutic option for these patients.
Patients who have progressed on a combination of both Temozolomide and Tumor Treating Field (Optune) or as single treatment Temozolomide (TMZ) OR Tumor Treating Fields (Optune) are eligible to receive APG-157. During APG-157 dosing, TMZ or Optune may be concurrently given at the decision of the Principal Investigator. APG-157 will be given until disease progression or intolerance by the patient.
Radiation followed by adjuvant Temozolomide for 6 to 12 months which is a current standard of care (SOC). Upon progression of this disease after SOC treatment, there are very limited further options for these patients. This expanded access administration will evaluate the potential of APG-157, a novel drug under development for head and neck cancer, as a potential treatment for these recurrent glioblastoma patients.
Brief Description of Objectives:
- Improve six-month progression-free survival (PFS) and overall survival (OS) of the patients eligible for the treatment under Expanded Access protocol.
- Improvement in Quality of Life
- Achievements of above two objectives without any Serious Adverse Events (SAEs) and adverse drug-drug interactions.
Brief Description of Plans for Efficacy Assessment:
- Improvement in Quality of Life
- Efficacy will be assessed using Imaging (objective tumor response using Response Assessment in Neuro-Oncology criteria (RANO), hematological assessment, and tolerance.
- Conditions
- Glioblastoma, Glioblastoma Multiforme
- Being tested
- APG-157
- Keywords
- Temozolomide, Tumor Treating Field, Optune, Progression
- Medical subject headings
- Glioblastoma, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APG-157Drug
APG-157 is an orally administered drug encased in a hydrogel pastille.
Arms:
- Ongoing Stupp protocol (will receive concurrent TMZ + APG-157)
- Progression post TMZ (will receive APG-157 only)
- Ongoing Optune (will receive concurrent Optune + APG-157)
- Progression post Optune (will receive APG-157 only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Aveta Biomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551013
- Sponsor's protocol ID
- BSW AVTA
- Status last verified
- Aug 2024
- First submitted
- 12 Sep 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Recurrent GBM With APG-157 Via Expanded Access
- ClinicalTrials.gov ID
- NCT05551013
- Acronym / sponsor ID
- BSW AVTA
- Conditions
- Glioblastoma, Glioblastoma Multiforme
- Keywords
- Temozolomide, Tumor Treating Field, Optune, Progression
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Aveta Biomics, Inc.Industry (pharma, biotech, devices)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This expanded access request will evaluate APG-157, a botanical drug under development for other cancers, as potential treatment for recurrent Glioblastoma multiforme (GBM) patients.
Detailed description
Glioblastoma patients with disease recurrence after primary, currently approved primary treatments have limited options. Therefore, this expanded access trial is designed to test a new therapeutic option for these patients.
Patients who have progressed on a combination of both Temozolomide and Tumor Treating Field (Optune) or as single treatment Temozolomide (TMZ) OR Tumor Treating Fields (Optune) are eligible to receive APG-157. During APG-157 dosing, TMZ or Optune may be concurrently given at the decision of the Principal Investigator. APG-157 will be given until disease progression or intolerance by the patient.
Radiation followed by adjuvant Temozolomide for 6 to 12 months which is a current standard of care (SOC). Upon progression of this disease after SOC treatment, there are very limited further options for these patients. This expanded access administration will evaluate the potential of APG-157, a novel drug under development for head and neck cancer, as a potential treatment for these recurrent glioblastoma patients.
Brief Description of Objectives:
- Improve six-month progression-free survival (PFS) and overall survival (OS) of the patients eligible for the treatment under Expanded Access protocol.
- Improvement in Quality of Life
- Achievements of above two objectives without any Serious Adverse Events (SAEs) and adverse drug-drug interactions.
Brief Description of Plans for Efficacy Assessment:
- Improvement in Quality of Life
- Efficacy will be assessed using Imaging (objective tumor response using Response Assessment in Neuro-Oncology criteria (RANO), hematological assessment, and tolerance.
Study design
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- This study will enroll patients with histologically confirmed glioblastoma (GBM).
- Patients must have received prior treatment with standard first-line therapy for GBM, including maximal surgical resection and postoperative external-beam radiotherapy or Tumor Treating Fields (Optune). Concurrent chemoradiation with TMZ or Tumor Treating Field (Optune) is allowed but not mandatory.
- Patients are eligible for enrollment only if they have unequivocal evidence of tumor recurrence/progression by MRI a minimum of 12 weeks following completion of radiation therapy or TMZ-Radiotherapy or Optune. Patients who have received prior bevacizumab or other anti-vascular endothelial growth factor(anti-VEGF) agents are not eligible to enroll.
- Baseline MRI should be performed within 28 days prior to enrollment.
- Other key inclusion criteria include Eastern Cooperative Oncology Group (ECOG) status of 0-1 (KPS ≥ 70%) and adequate bone marrow, hepatic, and renal function at baseline.
Key exclusion criteria (1 listed)
- Patients with severe neutropenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APG-157APG-157 is an orally administered drug encased in a hydrogel pastille. Arms: * Ongoing Stupp protocol (will receive concurrent TMZ + APG-157) * Progression post TMZ (will receive APG-157 only) * Ongoing Optune (will receive concurrent Optune + APG-157) * Progression post Optune (will receive APG-157 only) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing APG-157 in people with Glioblastoma and Glioblastoma Multiforme, run by Aveta Biomics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.