GlioblastomaPhase 2/3AFGB2NCT05669820
Antisecretory Factor Glioblastoma Phase 2
A Phase 2/3 study testing Salovum in people with Glioblastoma, run by Peter Siesjö at 1 site in Sweden.
Trial summary
This is a randomised, double blinded and multiple center , Phase 2 study in patients with newly diagnosed glioblastoma. Participants will receive an egg powder enriched for antisecretory factor (AF), Salovum, or a placebo egg powder daily from 2 days before concomitant radio-chemo therapy or chemotherapy until 14 days… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Salovum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jan 2024to 1 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathology verified glioblastoma or astrocytoma grade 4
- Age 18-75 years
- Surgical treatment-resection.
- Scheduled concomitant radiochemotherapy, or only chemotherapy.
- Informed consent
Who cannot join
- No informed consent
- Egg yolk allergy
- Only surgical biopsy
- Only radiotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Johan Bengzon, MD, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Skåne University Hospital
Lund, 22185
Peter Siesjö, MD, +46705655778, peter.siesjo@med.lu.se
Erik Ehinger, MD, +46707970783, erik.ehinger@med.lu.se
About this study
Official title: Antisecretory Factor During Concomitant and Adjuvant Therapy of Primary Glioblastoma, a Randomised, Prospective and Double Blinded Study
This is a randomised, double blinded and multiple center , Phase 2 study in patients with newly diagnosed glioblastoma. Participants will receive an egg powder enriched for antisecretory factor (AF), Salovum, or a placebo egg powder daily from 2 days before concomitant radio-chemo therapy or chemotherapy until 14 days after finalisation plus during adjuvant chemotherapy.The primary aims of are overall survival at 6 and 12 months after diagnosis
Read the detailed description
Glioblastoma (GB) is the most common primary brain tumor and also has the worst prognosis with a mean survival time below 1 year and a 5-year survival rate of less than 2%. AF is a 41kilodalton endogenous and essential protein with antisecretory and anti-inflammatory effects. Endogenous AF activity increases after exposure to bacterial toxins and endogenous triggers of inflammation. The active amino-terminal portion of AF has been synthesized as a 16 amino acid peptide (AF-16) and has been used in animal experimental studies. Salovum® is a product based on egg yolk powder B221® and contains high levels of AF. Salovum® is classified as food for special medicinal purposes (FSMP) by the European Union an din other countries.
Many tumors show elevated interstitial fluid pressure (IFP) compared to the surrounding tissue due to vascular leakage, providing a barrier for drug uptake in solid tumors, as well as poor perfusion, resulting in hypoxia and relative resistance to radiochemotherapy.
AF-16 was reported to significantly reduce the IFP in xenotransplanted human glioblastoma by inhibiting an ionic pump, NKCC1, in the tumor tissue. Both Salovum® and AF-inducing specific processed cereals (SPC) prolonged survival in the same models. Systemic temozolomide treatment combined with AF inducing SPC completely blocked tumor growth in GBM xenografts. Likewise, SPC treatment abrogated 90% of pre-established syngeneic tumors in immune competent animals.
Intratumoral delivery of AF-16 potentiated the effect of intratumoral temozolomide in an experimental model of glioblastoma.
Mechanistically, it remains unclear whether AF's effect in tumor models is mediated through decrease of IFP and/or immunomodulation. Also, an effect on the complement system through modulation of circulating complement complexes with proteasome units has been proposed.
Salovum® has been administered to patients with various diseases as, inflammatory bowel disease, Mb Ménière and mastitis and traumatic brain injury without signs of any adverse effects.
In a completed phase1-2 trial in participants with primary gliobalstoma the add on of Salovum during concomitant radiochemotherapa was considered safe and feasible.
The current study is aimed at assessing the efficacy of Salovum in a RCT (randomised controlled trail).
- Conditions
- Glioblastoma
- Being tested
- Salovum, Placebo egg yolk powder
- Keywords
- Antisecretory factor, Trials, Randomized Clinical
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalovumDietary supplement
Also called Antisecretory factor
Salovum is an eggyolkpowder derived from hens fed with SPC (specially processed cereals) and contains increased amounts of the endogenous protein antisecretory factor.
Placebo egg yolk powderDietary supplement
Egg yolk powder derived from hen fed with normal feed.
| Study group | Role | What they receive |
|---|---|---|
| Salovum | Active comparator | Salovum, an egg yolk powder will be orally at dose of 11 g 3 times daily. Receives: Dietary Supplement: Salovum |
| Placebo | Placebo comparator | Placebo, an egg yolk powder will be orally at dose of 11 g 3 times daily. Receives: Dietary Supplement: Placebo egg yolk powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Survival
Measured: up to 12 months from primary surgery
Secondary outcomes (1)
Progress free survival at 6 and 12 months
Progress free survival as a compound assessment by a multidisciplinary conference (MDC)
Measured: At 6 and 12 months from primary surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study start15 Jan 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, prospective, double blinded
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Siesjö
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor-investigator, Peter Siesjö, Skane University Hospital
- Investigators
- Charlotte Edwardsson, Study chair, Skane University HospitalErik Ehinger, MD, Study chair, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669820
- Sponsor's protocol ID
- FPAFGB2ver6
- Acronym
- AFGB2
- Status last verified
- Oct 2025
- First submitted
- 20 Dec 2022
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and analysed in the current trial will be available in anonymized form after completion of the study, on reasonable request.
Publications
Ehinger E, Darabi A, Visse E, Edvardsson C, Tomasevic G, Cederberg D, Kinhult S, Rydelius A, Nilsson C, Belting M, Bengzon J, Siesjo P. Antisecretory factor as add-on treatment for newly diagnosed glioblastoma, IDH wildtype: study protocol for a randomized double-blind placebo-controlled trial. Trials. 2025 Mar 13;26(1):86. doi: 10.1186/s13063-025-08792-z.
PubMed 40083039
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antisecretory Factor During Concomitant and Adjuvant Therapy of Primary Glioblastoma, a Randomised, Prospective and Double Blinded Study
- ClinicalTrials.gov ID
- NCT05669820
- Acronym / sponsor ID
- AFGB2 / FPAFGB2ver6
- Conditions
- Glioblastoma
- Keywords
- Antisecretory factor, Trials, Randomized Clinical
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peter SiesjöUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 3 Jan 2023 (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 is a randomised, double blinded and multiple center , Phase 2 study in patients with newly diagnosed glioblastoma. Participants will receive an egg powder enriched for antisecretory factor (AF), Salovum, or a placebo egg powder daily from 2 days before concomitant radio-chemo therapy or chemotherapy until 14 days after finalisation plus during adjuvant chemotherapy.The primary aims of are overall survival at 6 and 12 months after diagnosis
Detailed description
Glioblastoma (GB) is the most common primary brain tumor and also has the worst prognosis with a mean survival time below 1 year and a 5-year survival rate of less than 2%. AF is a 41kilodalton endogenous and essential protein with antisecretory and anti-inflammatory effects. Endogenous AF activity increases after exposure to bacterial toxins and endogenous triggers of inflammation. The active amino-terminal portion of AF has been synthesized as a 16 amino acid peptide (AF-16) and has been used in animal experimental studies. Salovum® is a product based on egg yolk powder B221® and contains high levels of AF. Salovum® is classified as food for special medicinal purposes (FSMP) by the European Union an din other countries.
Many tumors show elevated interstitial fluid pressure (IFP) compared to the surrounding tissue due to vascular leakage, providing a barrier for drug uptake in solid tumors, as well as poor perfusion, resulting in hypoxia and relative resistance to radiochemotherapy.
AF-16 was reported to significantly reduce the IFP in xenotransplanted human glioblastoma by inhibiting an ionic pump, NKCC1, in the tumor tissue. Both Salovum® and AF-inducing specific processed cereals (SPC) prolonged survival in the same models. Systemic temozolomide treatment combined with AF inducing SPC completely blocked tumor growth in GBM xenografts. Likewise, SPC treatment abrogated 90% of pre-established syngeneic tumors in immune competent animals.
Intratumoral delivery of AF-16 potentiated the effect of intratumoral temozolomide in an experimental model of glioblastoma.
Mechanistically, it remains unclear whether AF's effect in tumor models is mediated through decrease of IFP and/or immunomodulation. Also, an effect on the complement system through modulation of circulating complement complexes with proteasome units has been proposed.
Salovum® has been administered to patients with various diseases as, inflammatory bowel disease, Mb Ménière and mastitis and traumatic brain injury without signs of any adverse effects.
In a completed phase1-2 trial in participants with primary gliobalstoma the add on of Salovum during concomitant radiochemotherapa was considered safe and feasible.
The current study is aimed at assessing the efficacy of Salovum in a RCT (randomised controlled trail).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, prospective, double blinded
| Arm | Type | Receives |
|---|---|---|
| Salovum | Active comparator | Dietary Supplement: SalovumSalovum, an egg yolk powder will be orally at dose of 11 g 3 times daily. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo egg yolk powderPlacebo, an egg yolk powder will be orally at dose of 11 g 3 times daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathology verified glioblastoma or astrocytoma grade 4
- Age 18-75 years
- Surgical treatment-resection.
- Scheduled concomitant radiochemotherapy, or only chemotherapy.
- Informed consent
Key exclusion criteria (4 listed)
- No informed consent
- Egg yolk allergy
- Only surgical biopsy
- Only radiotherapy
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 |
|---|---|---|
| SalovumAlso: Antisecretory factorSalovum is an eggyolkpowder derived from hens fed with SPC (specially processed cereals) and contains increased amounts of the endogenous protein antisecretory factor. | Dietary supplement | Salovum |
| Placebo egg yolk powderEgg yolk powder derived from hen fed with normal feed. | Dietary supplement | Placebo |
Primary outcome
Overall survival
Time frame: up to 12 months from primary surgery
Survival
1 secondary outcome
Progress free survival at 6 and 12 months
Time frame: At 6 and 12 months from primary surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Derived from this study: PubMed 40083039Ehinger E, Darabi A, Visse E, Edvardsson C, Tomasevic G, Cederberg D, Kinhult S, Rydelius A, Nilsson C, Belting M, Bengzon J, Siesjo P. Antisecretory factor as add-on treatment for newly diagnosed glioblastoma, IDH wildtype: study protocol for a randomized double-blind placebo-controlled trial. Trials. 2025 Mar 13;26(1):86. doi: 10.1186/s13063-025-08792-z.
- Individual participant dataSharing planned: No. The datasets used and analysed in the current trial will be available in anonymized form after completion of the study, on reasonable request.
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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.
Johan Bengzon, MD, PhD contact
Charlotte Edwardsson study chair
Skane University Hospital
Erik Ehinger, MD study chair
Skane University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Salovum in people with Glioblastoma, run by Peter Siesjö at 1 site in Sweden.
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 4 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: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Siesjö, MD, PhD (+4646171274, peter.siesjo@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: up to 12 months from primary surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05669820, which also lists 1 linked publication.
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 Jan 2026.